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Thread: RGOs looking for more information, experiences

  1. #1
    Senior Member NW-Will's Avatar
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    RGOs looking for more information, experiences

    Hi,

    I'm trying to find good information links experiences with any
    type of RGO. (ARGO HKFO FES-RGO) etc..

    I'm T4 incomplete less than 10 months post injury
    and have been using KAFO's for a month
    with a walker, doing the swing though technique looking to
    graduate to crutches. The weight of the device seems
    to make little difference to me, so I am really interested
    in RGO devices. I'm intrigued to see if I could get a
    gait type walk with an RGO device. Especially the device
    referred to as the para walker. Being stable enough to
    make it truly functional.


    AFO - Ankle Foot Orthosis
    RGO - Reciprocating Gate Orthosis -
    http://www.centerfororthoticsdesign....rgo/index.html

    KAFO - Knee Ankle Foot Orthosis

    HKAFO - Hip Knee Ankle Foot Orthosis
    http://www.fidelityorthopedic.com/orthodicproducts.html

    ARGO - Advanced Reciprocating Gait Orthosis
    http://www.rslsteeper.co.uk/NetsiteC...d/14/argo.html

    FES-RGO - ?????

    http://www.oandp.org/jpo/library/2001_01_010.asp

    Also has anyone had any experience with a reciprocating walker??
    http://www.alibaba.com/product-gs/20...ng_walker.html

    Thanks for any links or video.

  2. #2
    Senior Member NW-Will's Avatar
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    This site is cool and has a great RGO link, haven't been able
    to figure what injury level the guy has yet.

    howtoadapt.com

    howtoadapt.com RGO Page


    THE NEW GENERATION OF R.G.O.'S Nor Cal Design

  3. #3
    Senior Member NW-Will's Avatar
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    Interesting article, and as recent as I have been able to find

    Anyone have any experience with the RGO generation II ?
    Pictures
    Experiences?
    Comments.

    Article can be found here....
    http://www.medscape.com/viewarticle/408503

    Evaluation of 70 Paraplegic Patients Treated With the Reciprocating Gait Orthosis Powered by Muscle Stimulation

    Moshe Solomonow, PhD, MD (Hon), Ervin Aguilar, PharmD, Efrain Reisin, MD, Richard V. Baratta, PhD, and Robert D'Ambrosia, MD, Louisiana State University Medical Center, New Orleans, La.
    Medscape General Medicine 1(3), 1999. © 1999 Medscape

    Posted 06/24/1999
    Abstract and Introduction

    Abstract

    Seventy paraplegics (low-level injury) were fitted with an improved Reciprocating Gait Orthosis (RGO II) powered with or without electrical stimulation of the thigh muscles as a secondary rehabilitation phase for 2 to 48 weeks (mean 16). The success/failure ratio was dependent on the injury level, which was 1:1 for paraplegics with injury level at C-6/7; 1.67:1 for those with injury of T-1/3; and about 4:1 for paraplegics with injury level from T-3 to T-12. Lack of motivation and medical problems unrelated to the RGO II treatment were the primary reasons for failure.
    After an average of 14 weeks of training during which patients walked for 3 hours per week (1 hour 3 times per week), a significant reduction in spasticity, total cholesterol and low-density lipids, hydroxyproline/creatinine ratio, and knee extensor torque were evident.

    The RGO II is a viable orthosis for restoring standing and limited walking in paraplegics while providing sufficient function, safety, and reliability. The most appropriate use of such an orthosis is primarily in the patient with T-3 to T-12 injury level and good motivation, although selected patients with higher injury levels also can benefit. Regular use of the RGO II, even for exercise only, has a positive impact on the patient's health and outlook, with a general improvement in the paraplegic's physiological condition if used for a minimum of 3 to 4 hours per week.

    Introduction

    It is well-established that the major functional loss following injury to the thoracic spine is the inability of the patient to independently stand up and walk in the environment encountered while engaging in normal daily activities. While the wheelchair can provide an adequate replacement for the lost function, it leaves the patient with a set of secondary, but not unimportant, problems. They include contractures in the hip, knee, and ankle; the formation of heterotopic ossification of these joints; pressure sores; spasticity; reduced cardio-circulatory and pulmonary functions; and frequent urinary tract infection due to stagnation of fluids in the bladder. The traditional medical treatment to combat these secondary problems is long-term medication regimes, occasional hospital admission, and multiple surgical procedures. The cost of such typical treatment for one patient over a 25- to 30-year period is estimated to be more than $1 million (Headden S: Guns, Money, and Medicine. US News and World Report 121(1):30-40, 1996.), a serious drain on healthcare resources. The accompanying psychosocial burden on these patients over the same period also has significant negative impact on their rehabilitation process, attempts to gain employment, and family and social life.
    Over the years, attempts have been made to provide paraplegics with orthotic devices aimed at independent locomotion in a limited environment. The calipers (or long leg braces)[1-5] and the Hip Guidance Orthosis (HGO)[6-8] (also known as the Parawalker) have been used by many paraplegic patients in the US and Europe in the past two to three decades. In addition, we have applied the Reciprocating Gait Orthosis (RGO) to paraplegic patients in the US since 1980, following successful results in spina bifida patients.[9-11] The common limitation of these three orthotic systems was the relatively high energy consumption associated with their use.[11] Recognizing this problem, our group undertook research and development to adapt the RGO to paraplegic use with specific redesign of the hip and knee joints, as well as to introduce electrical stimulation of the quadriceps and hamstrings muscles to facilitate the standing-up function and produce the swing and push-off phases of the legs during locomotion.[9] The preliminary evaluation of this new system (RGO II) resulted in significant improvement in function and patient independence, as well as reduction of energy cost.[11]

    Since 1993, we have undertaken a full evaluation of the RGO II on a relatively large number of paraplegic patients to assess its function, utility, and acceptability by the patient.[12,13] Patients representing the general paraplegic population in age, level of injury, time since injury, and various medical complications were selected (as opposed to a highly-selected group) to assess the general utility of the orthosis. An additional aim of this study was to evaluate the changes in some physiological and metabolic parameters in paraplegic patients following the use of the RGO II.

    Materials and Methods

    The project protocol, including the fitting of the RGO II and the medical evaluation procedure, were approved by the Institutional Review Board (IRB) prior to screening patients.
    Screening of patients consisted of a general orthopedic examination of the extremities and spine to determine joint integrity, sufficient bone density, possible heterotopic ossification, spinal stability, and contractures. Full sets of radiographs of the lower extremities and spine were available. In addition, the patient's medical history was reviewed for medical problems that may interfere with or contraindicate the use of the RGO II (eg, cardiovascular or metabolic problems, medications, pregnancy).

    Participation in the study was limited to patients with spasticity ranging from none to severe, contractures of all levels as long as the joint was flexible to manipulation, mild to moderate osteoporosis, pressure sores in areas that would not be in contact with the orthosis or stimulating electrodes, sufficient arm/hand function to use a walker and press the stimulator switches, stable spine, and cardiopulmonary system integrity.

    The criteria excluded patients with nonflexible contractures, heterotopic ossification of the hip, knee, or ankle joints, severe osteoporosis, pregnancy, patients under medication for cardiopulmonary problems, malunion of fractures in the lower extremity, or severe deformities of the spine or lower extremities. Patients with pressure sores in areas that could make contact with the orthosis or stimulating electrodes were also excluded.

    Patients ranging in age from 16 to 55 with various levels of injury, spasticity, contractures, heterotopic ossifications, scoliosis, and other problems were accepted into the program (some with additional preambulatory treatment, eg, tendon lengthening, removal of joint ossification, and physiotherapy) to provide the maximal breadth and depth of perspective in evaluating the RGO II with respect to the general paraplegic population.

    Patients were initiated with the fitting of the RGO, and after final calibration received several weeks of gait training including standing up, sitting down, walking on flat surfaces, grass, or ramps, and negotiating curbs. Simultaneously, patients with thigh muscles that responded to electrical stimulation (normally T-10 or higher injury level) received up to 20 stimulation sessions in order to strengthen the muscles and reverse the atrophy due to the paraplegia.

    Patients were then trained to walk, stand, and sit using the RGO powered with a portable muscle stimulator for 5 to 12 additional sessions as necessary.

    Patients with contractures of the lower extremity received additional therapy sessions in order to reduce the contractures to levels acceptable and necessary for stable balance and locomotion.

    Results

    Patient Data
    The patient population fitted with the RGO II consisted of 50 males and 20 females who voluntarily sought treatment with the RGO II. Injury level distribution is noted in Figure 1A. The majority of patients fell into the T-11/12, T-8/10, and T-4/7 categories. Other categories included were T-1/3 and C-6/7. Type of spinal cord injury is shown in Figure 1B; gun shot wounds were the most frequent cause of paraplegia in this group. Figure 1C describes when the patients were admitted and Figure 1D gives the age distribution of the cohort.






    Figure 1. Data describing distribution of the 70 patients who participated in evaluation according to: A) injury level; B) cause of injury (GSW = gun shot wound, MVA = motor vehicle accident, MED = medical, IND = industrial accident, OTH = other); C) time since injury; and D) age at beginning of therapy.
    Training Outcome

    The training outcome showed that 66 (94.3%) patients were able to don and doff the RGO II equipment independently, whereas 4 (5.7%) needed assistance (Fig. 2A). Fifty-three patients (76%) were able to stand up from the seated position without help, and 17 (24%) required assistance (Fig. 2B).



    Figure 2. Data describing distribution of patients according to performance criteria, including: A) ability to independently don and doff RGO II; B) ability to independently stand up from a seat; C) ability to independently ambulate distances of 180m to more than 450m; and D) ability to independently walk on grass, ramps, and over curbs.
    After patients completed their training period to the satisfaction of the staff (ie, the staff felt that near-optimal performance was obtained according to the patient's individual circumstances, such as weight, injury level, etc.), the following was noted: 13 patients could continuously walk without assistance for at least 180m, 9 walked up to 270m, 11 walked up to 360m, and 18 walked up to 450m. Nineteen patients walked distances over 450m, as shown in Figure 2C. Several patients managed to walk more than 1,000m.

    At the end of the training period, 77% of the patients could walk independently on grass, up and down handicap ramps, and up and down curbs. Twenty-one percent of the patients did not wish to attempt walking on anything other than flat, smooth surfaces, and 1.5% of the patients negotiated with the grass, curbs, and the ramp with active assistance (Fig. 2D).

    The success/failure ratio based on the criteria set (Fig. 3A) consisted of 75.7% of the patients successfully completing the training, whereas 24.3% were considered failures. The relationship between the success or failure and the injury level (Fig. 3B) was significant, as 17 patients with injury level at T-11/12 succeeded and 4 failed, yielding a ratio of 4.25:1. At the T-8/10 level, 15 patients succeeded and 4 failed (3.75:1). At the T-4/7 level, 14 patients succeeded and 4 failed (3.5:1), while 5 patients with T-1/3 injury level succeeded and 3 failed (1.66:1). At the C-6/7 level, 2 patients succeeded and 2 failed (1:1).




    Figure 3. Success/failure data of the 70 patients accepted to the RGO II rehabilitation treatment including: A) success/failure ratio; B) success/failure distribution as function of injury level; and C) causes of failure.
    The cause for failure was diverse, as shown in Figure 3C. Nine patients abandoned the use of the RGO II due to medical problems not related to the use of the RGO II (eg, pressure sores, lack of physical strength, bone fractures), and 2 patients abandoned the program due to personal problems (moving away, death in family). Five patients left the program due to lack of motivation, and 1 patient was dismissed due to behavioral problems.

    The duration of the treatment from beginning to discharge is shown in Figure 4A. Eight patients completed the program within 4 weeks (on an inpatient basis); 8 patients within 8 weeks; 9 patients within 12 weeks; and 10 patients within 16 weeks. Overall, more than half of the patients completed the program within 16 weeks, with nearly one quarter of the patients finishing within 8 weeks. The remainder of the patients required up to 48 weeks of treatment.




    Figure 4. Treatment duration of the 70 patients who underwent rehabilitation with RGO II including: A) distribution of patients according to treatment duration from start to end; and B) treatment duration as function of injury level.
    The duration of treatment (beginning to discharge) versus injury level (based on 3 visits per week) was 86 (average 47) days for patients with T-11/12 injury; 115 (average 73) days for patients with T-8/10 injury; and 114 (average 56) days for T-4/7 injury (Fig. 4B). Patients with T-1/3 injury required 137 (average 75) days to complete the training, and patients with C-5/6 injury required 144 (average 36) days.

    Spasticity

    The effect of electrical stimulation of the thigh muscle on spasticity varied among the patients as shown in Figure 5. Of the 70 patients in the study, 33 patients participated in this investigation. Of the 37 patients who did not participate, 21 patients with lower motor neuron damage (T-11 or T-12) were excluded, as they did not receive electrical stimulation therapy. Eleven patients did not suffer from any appreciable spasticity, and 5 did not respond.




    Figure 5. Effect of electrical stimulation on spasticity.
    Twenty (61%) of the 33 patients who participated reported a significant reduction in spasm that lasted for 1 and up to 3 days. Two patients (6%) reported a significant but short-term reduction that lasted for several hours. Three (9%) patients reported only a slight reduction in spasticity due to the electrical stimulation, and 5 (15%) reported no change in frequency or strength of the spasms. The remaining 3 (9%) patients reported decreased frequency of spasms but increased strength (eg, force) when spasms did occur.

    Lipid Profiles

    Figure 6 shows that 8 patients with an initial high total cholesterol level (>200mg/dL) demonstrated a significant (paired t-test, p<0.02) decrease from 231mg/dL to 196mg/dL at the end of their training (average length of training = 14.6 weeks). Their HDL showed a slight, insignificant decrease, while the LDL level demonstrated a significant (p=0.009) decrease from 160mg/dL to 130mg/dL. Twenty patients with initial normal cholesterol levels (<200mg/dL) did not register a statistically significant change in total cholesterol, HDL, or LDL levels (Fig. 7). The remaining 42 patients took the initial blood test, but either did not want to take the final test or did not comply with the fasting requirement.




    Figure 6. Variations in total cholesterol, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) levels in 8 patients who started RGO II program with total cholesterol level >200 mg/dL.




    Figure 7. Variations in cholesterol and lipid levels in 20 patients whose total cholesterol was normal (<200 mg/dL).
    Serum Calcium and Alkaline Phosphatase Levels

    Blood test samples taken in the initial and final days of the RGO II training show a decrease in serum calcium and alkaline phosphatase levels, although the decrease was not statistically significant (Fig. 8). Only 8 patients were included in this analysis as the other 20 patients sustained spinal injury less than 2 years prior to the treatment and their bone metabolism had not stabilized.[14,15]




    Figure 8. Changes in serum calcium and alkaline phosphate levels during RGO II program.
    Urine Studies

    Urine tests in the same 8 patients resulted in a statistically significant (paired t-test, p=.018) reduction in the hydroxyproline/creatinine ratio over the training period with slight, nonsignificant reduction in calcium/creatinine ratios (Fig. 9).



    Figure 9. Variations in hydroxyproline, calcium, and creatinine levels as measured from urine tests during RGO II training.
    Cardiac Output and Stroke Volume

    An increase in cardiac output was present at the end of the RGO II training period (Fig. 10), increasing from 5.05 L/minute at the beginning of the training to 5.41 L/minute. The change, however, was not statistically significant (paired t-test) due to the large variability. Similarly, the stroke volume increased from 66.7mL at the beginning of the RGO II training to 70.05mL at the end of the training. This change was not statistically significant.



    Figure 10. Cardiac output and stroke volume of patients at beginning and end of RGO program.
    Vital Capacity

    The average vital capacity of the patients increased by 14.7% over the RGO II training program as shown in Figure 11. The subjective nature of this test resulted in relatively large variability, yet it demonstrates the overall improvement in pulmonary function.



    Figure 11. Changes in vital capacity due to use of RGO II.
    Muscle Hypertrophy



    Figure 12 demonstrates that a strong improvement in quadriceps torque had occurred by the end of the RGO II training. An average increase of 78.2% was measured from the 23 patients who completed this test, demonstrating the effect of the muscle stimulation component of the RGO II.



    Figure 12. Increase in quadriceps torque due to use of muscle stimulation during locomotion with RGO II.
    Heart Rate



    Figure 13 illustrates the initial and final heart rate of the 70 patients after walking 30m on a level surface at their preferred average speed of 0.22m/s (average 0.09). The figure also compares the initial and final heart rates when patients walked in the RGO II with the heart rates associated with walking in the RGO,[11] the Parawalker,[16] the Long Leg Brace (LLB),[17] Marsolais[17] muscle stimulation walking system, and the Parastep.[18] The initial and final heart rate data of the other walking orthoses were taken under conditions somewhat different from those described in the literature.[11,14-16]The RGO II demonstrates the lowest heart rate of 119 pulses per minute at the end of the 30m walk compared with the 131 pulses/minute for the original RGO, the 134 pulses/minute for the Parawalker, the 150 pulses/minute for the LLB, the 161 pulses/minute for the Marsolais muscle-stimulation orthosis, and the 170 pulses/minute for the Parastep.

    Post-discharge Survey

    Forty-one of the 70 patients treated in the RGO II program were contacted for purposes of assessing the orthosis' use, utility, and impact on the patient's quality of life. The remaining 29 could not be located due to changed addresses.

    Of the 41 patients participating in the postdischarge assessment, 9 (22%) used the RGO II more than 3 times per week; 11 (26.8%) used it 1 to 3 times per week; 5 (12.2%) used it 1 or more times per month; and 8 (19.5%) used it regularly but were at present not using it due to nonrelated medical conditions (eg, pressure sores, pregnancy, burns); however, they were planning to resume usage when conditions were resolved. Eight patients (19.5%) were found to be nonusers. The nonusers indicated the following reasons for not using the orthosis: environment around their homes was not conducive to using the RGO II; demands of attending school full-time; having no time in general; and absence of family support.

    In summary, 80.5% of the 41 patients contacted were using the RGO II on a regular basis, and 19.5% were nonusers. Thirty-nine patients indicated that they were satisfied with the RGO II and that it met their expectations; 2 patients expressed disappointment. Interestingly, 6 of the 39 patients who expressed satisfaction were nonusers.

    Thirty-eight patients indicated that they were not willing to return the RGO II for a refund under any circumstances, whereas 3 patients indicated they would return it. Despite the wide variability in the frequency of usage of the orthosis, it seems that it had significant importance in the physical and psychological domains of the patients' lives.

    The mode of usage shed light onto the importance of the RGO II on the patient's quality of life. Twenty-seven (65.9%) patients were using it as a mode of exercise and 6 (14.6%) were using it in daily life functions, such as shopping or visiting friends, during social occasions (eg, church, clubs, barbecues), to do housework, and for "going places."

    Twenty-three of the 41 (56%) patients provided additional commentary on the RGO's influence in improving quality of life, indicating that the use of the orthosis had a distinct and noticeably positive impact on one or more of the following: spasticity, bowel and bladder functions, endurance, back or muscle pain, energy and appetite, weight control, skin problems, or posture and range of motion. Improvement in these areas was, in fact, the motivation for RGO II use by the group of patients who employed the orthosis for exercise purposes.

    Of the 41 patients who were surveyed, 26 were given the RGO II including the muscle stimulator, whereas 15 patients were given only the mechanical orthosis due to lower motor unit damage. Of the 26 patients who had the complete RGO II system, 7 were nonusers and 19 were users. All 19 patients used the muscle stimulator unit separately as well, in order to suppress spasticity, improve skin condition, and maintain muscle tone and cosmetic appearance of the legs.

    Finally, none of the 41 patients surveyed had any medical problems related to the RGO II. The equipment of several patients required routine maintenance, such as adjustment of the brace due to weight change or repair due to wear. Several patients also reported repair to the muscle stimulator due to damage incurred when it was dropped. One stimulator was submerged in water during the Midwest flood in 1994 and was returned for replacement after its recovery.

    Discussion

    Patient Selection
    One of the aims of this evaluation was to assess the function and performance of the RGO II on the widest possible paraplegic population. Jaeger and colleagues[19] pointed out succinctly that if highly selective criteria are set, various types of walking orthoses may apply only to less than 5% of the spinal cord injury population. It is important, therefore, to assess acceptability of a walking orthosis on the largest population possible to justify any efforts and financial investments in developing and applying such devices to paraplegic patients. Our data indicate that patients who otherwise would not be selected to participate in such rehabilitation programs did participate and many completed them successfully. Of the 72 applicants to the program, 2 were not accepted due to nonunions in the femur and severe cardiac problems.

    The most important finding of the evaluation is that over 75% of the paraplegics admitted to the program completed it successfully, and that the success ratio was highly dependent on the injury level.

    Independent Ambulation

    According to the definition of success/failure as given in the "Methods" section, each patient categorized as successful was able to don and doff the RGO II equipment, stand up from the seated position, ambulate at least 180m, and negotiate with grass, ramps, and curbs, all without any assistance. This implies that such a patient could take his RGO II home and use it for personal objectives without burdening family members. This is an important point to consider: independence from assistance from family members does not limit the use of the RGO II to evenings and weekends (when family members are available). In fact, the modifications of the RGO were performed with this objective in mind (ie, allowing paraplegics to put on and use the orthosis at any time, without expecting or depending on assistance). Furthermore, the ability to negotiate with simple environmental features such as ramps, grass, and curbs affords patients the option of using the RGO II both in and out of their homes, greatly improving their options. This conclusion is justified if one assumes that a wheelchair-bound paraplegic patient has already made arrangements for accessibility to the home for the chair in the form of ramps. The ability to walk at least 180m continuously may not seem an exceptionally long distance, yet considering the typical home size, this distance is more than sufficient to allow functional use of the RGO II. The outdoor utility of the RGO II was demonstrated by many of our patients after discharge, as they reported using the orthosis to walk in their garden, take a short stroll in a nearby park with the children and dog, walk into church or synagogue, and host barbecues for family and friends on weekends.

    While 13 patients could walk a distance of only 180m, more than half of the patients could walk continuously up to distances of or exceeding 450m (several patients could walk distances of 1,000m). This is certainly a sufficient range for utilizing the RGO II for various purposes inside and outside the home, excluding environments with staircases or other barriers.

    A limiting factor in some circumstances was the relatively low speed of ambulation. The average speed for the patients we treated was 0.22 m/s.[11] Most of the patients stated that under the circumstances they planned to use the RGO II -- its low speed was not a problem. That stable, safe, and balanced standing and walking and the free use of hands during standing were achievable was much more important than the speed of locomotion. Yet, on some occasions, the patients preferred to use the wheelchair, as its speed offered an advantage for a specific function. The overall outcome posttherapy shows that the combined use of the wheelchair and the RGO II was the preferred mode for most patients. A typical example is the option to roll the wheelchair to a park a block or two away and upon arrival to stand up and walk with the RGO II. Another example often reported is the use of the wheelchair to cross a large parking lot when transporting from a car to an enclosed shopping mall, and the use of the RGO II in the mall itself.

    Failures

    It is important to review the cases that constituted the 24.3% failure, and to derive the appropriate conclusions. The majority of the cases (9) that did not result in a successful completion of the training program were due to medical reasons such as fractures of leg bones, development of pressure sores, high blood pressure, pregnancy, and a preexisting chronic pain which prevented the patient from concentrating on therapy. Two C-6/7 paraplegic patients were designated as failures due to a lack of physical ability to use the orthosis (ie, strength to control the orthosis). None of these medical reasons was secondary to the use of the RGO II. Only 1 patient suffered a femur fracture during the preambulatory therapy administered to reduce contractures.

    At the time of the writing of this report, 4 of the patients who were earlier classified as failures due to pressure sores and bone fractures had returned after recovery and completed the training successfully. These cases could be designated as temporary failures, demonstrating that aggressive therapy may result in positive outcome over time.

    The second largest, and probably the most important, reason for failure was the lack of motivation exhibited by 5 patients. They did not keep their therapy appointments, and stopped and started the program several times without attempting to make reasonable progress. If one considers that sufficient aggressiveness and dedication on the part of the patient was absolutely necessary to overcome initial difficulties, the predicted success of a given paraplegic patient was directly dependent on his motivation. We found during the course of several years that well-motivated patients, determined to complete the therapy and be able to walk independently, were able to overcome a variety of serious physical obstacles (eg, being significantly overweight, having contractures and spasms) and succeed, whereas unmotivated patients with excellent physical characteristics did not. We recommend that some type of test be constructed and employed in the screening phase of any similar program to determine that sufficient motivation level is exhibited by the patients to guarantee a successful outcome. Otherwise, the large investment of time and cost (typical to such therapy) is not efficient.

    Two patients discontinued the program due to personal reasons (moving away, death in the family); 1 patient was dismissed due to an abusive attitude toward the staff.

    The success/failure ratio demonstrates a relationship with the level of injury. The ratio was 1:1 for C-6/7 patients and 1.66:1 for T-1/3 patients, whereas it jumped to about 4:1 for patients with injuries ranging from T-3 and below. It seems, therefore, that patients with a high injury level had more medical problems or a limited ability to perform with the RGO II compared to paraplegics with injury levels below T-3. Obviously, individuals with a high injury level had less control of their upper trunk and shoulders, accompanied by partial weakness of the upper extremities. They often required more assistance in donning and doffing the RGO II, in standing up, during walking, and especially when negotiating with grass, ramps, and curbs. The walking distance was also limited, yielding a low overall performance.

    Cost Analysis

    The superficial conclusions one can draw from the data is that perhaps the time and investment of funds associated with training paraplegics to utilize the RGO II is optimally expanded for individuals with a lesion below T-3. Such a conclusion, however, must be qualified with well-established medical observation. Therapy or medical treatment to the physically challenged patient is based on individual situations, in which the treatment objectives are custom-tailored for each patient and may vary across a wide spectrum. For example, the typical objective for a high-level paraplegic patient was to stand up and walk a few minutes once or twice a day, often when assistance from a family member was available. Such minimal activity has a negligible impact on performance of functions of daily living, but has a major and significant impact on the patient's psychological and medical condition. Standing up and walking a few minutes every day seemed to greatly improve the outlook of the patients in this category and also relieved the pressure, heat, and poor circulation in the lower body. The same minimal usage of the RGO II also allowed sufficient stretching and cycling of the lower extremities, probably reducing the potential for severe contractures and reducing spasticity. The question remains, therefore, as to the criteria one should use in determining whether individuals with injury levels above T-3 should or should not be considered for treatment with the RGO II (or other similar devices). A conclusive answer to such a question is further complicated if we consider that the 2 patients with C-6/7 who succeeded were fully independent in performing all functions, whereas the other 2 patients who failed were unable to perform physically.

    Prolonged Therapy

    Another important factor affecting the utility and availability of an orthosis is the duration of therapy or training required of the patient and the medical staff to produce a positive outcome. The treatment/therapy duration, therefore, has a direct impact on the overall cost of the orthosis and its acceptability by the medical staff and administration. Figure 4A demonstrates that more than one-third of the paraplegics completed the program within 12 weeks, during which they visited the outpatient clinic 3 times per week, to yield an overall total of 36 visits. More than half of the patients completed the program within 16 weeks (or 48 visits), indicating that a relationship exists between the injury level and therapy duration (Fig. 4B). Paraplegics with high injury levels at C-6/7 and T-1/3 required well over an average of 120 days to complete the program, whereas patients with injury levels below T-3 required less than an average of 120 days to complete the therapy. Again the question of possible success versus the cost of this type of rehabilitation when applied to high-level paraplegic patients is raised. It is clear from the data presented that the prospect for success is near 1:1 for high-level paraplegic patients, and that the cost is eventually much higher as well. Furthermore, high-level paraplegic patients also accounted for the majority of the individuals who had lower performance than others in standing up, donning and doffing the equipment, distance walked, and ability to negotiate with grass, ramps, and curbs.

    Not all of the individuals who required prolonged therapy consisted of paraplegic patients with high-level injuries. We noted that patients who were overweight and/or had moderate or strong contractures required additional time to become proficient with the orthosis and arrive at their optimal performance prior to discharge. The positive effects of the prolonged treatment were, however, clear. The overweight patients decreased their weight as they became more proficient in the use of the orthosis, and they walked longer distances. Loss of 7kg to 10kg was not unusual in the 8 overweight individuals. The reductions in weight were accompanied by significant drops in low-density lipoproteins and total cholesterol.

    Longer therapy duration was also common for patients with hip, knee, and/or ankle contracture. Again, the prolonged therapy resulted in positive outcomes that became apparent in the last weeks of the treatment. The upright posture loaded the ankle joint and opposed the contracture. With time, the ankle contracture diminished to insignificant levels. Based on such observation, we no longer expand efforts in direct application of conventional physiotherapy to patients with ankle contractures in the preambulatory phase. As long as the ankle joint is flexible, weightbearing is a satisfactory therapy in the ambulatory RGO II training, saving expensive therapy time.

    Contractures of the hip and knee joints were more difficult to treat. Preambulatory treatment was prolonged and the patients had some difficulties locking their hip and knee joints for the initial gait training with the orthosis. Care was constantly taken to prevent excessive or prolonged pressure from the hook and loop fastener straps securing the knee in the mechanical frame of the RGO II. With time, however, the upright posture and the walking, together with the preambulatory treatment for contractures, resulted in a significant increase in the passive range of motion of the three joints. In the end, patients with moderate but flexible contractures of the hip, knee, and/or ankle performed just as well as other patients, fully justifying the increase in treatment duration. Patients with severe contractures responded to the contracture treatment favorably, yet never gave an acceptable performance, and in some cases contributed to the number of failures. In one case, tendon-lengthening surgery was performed to relax the contracture of the ankle. After recovery, the patient re-entered the program and completed it successfully.

    Physiological Benefits

    The most important finding of the medical evaluation is that there is a positive impact on the general physiological condition of the patients who walked with the RGO II for a minimum of 1 hour, 3 times a week. This includes improvement in spasticity, cholesterol level, bone resorption, cardiac and pulmonary functions, and muscle tone. However, while all the above parameters showed improvements due to limited ambulation with the RGO II, not all improvements were statistically significant.

    Osteoporosis

    Limited activity might accelerate bone loss, inducing osteoporosis and increasing the risk for fracture.[15] Paraplegic patients, however, rapidly develop osteoporosis in the bones located below the spinal cord lesion not only because of "disuse," but also because the neurological lesions induce local metabolic alterations characterized by an increased synthesis and degradation of bone in the first 2 years following injury.[14,20]

    To analyze the effect of the RGO II on osteoporosis development in paraplegic patients, we evaluated changes in several biochemical parameters of bone remodeling in 8 patients who were enlisted in the RGO II training 2 years postinjury. This cut-off was used because the bone metabolic profile in paraplegic patients achieves equilibrium status only 2 years after the neurological lesions occur.[14]

    We have shown that after a short period in our program (average 4 weeks), patients have a slight decrease in serum calcium and alkaline phosphatase levels and a significant decrease in urinary excretion of hydroxyproline. This results in a strong and significant decrease in the hydroxyproline/creatinine ratio, which suggests a decrease in bone resorption induced by the loading of the bones of the lower body and the aerobic training and locomotion made possible by the use of the RGO II.

    Cardiovascular Improvement

    Patients with spinal cord injury have a significantly higher incidence of cardiovascular morbidity and mortality compared with an age-matched population.[21] Previous large epidemiological studies in the general population have shown levels of HDL-cholesterol are inversely related to the incidence of coronary artery disease.[22,23] Investigators have shown that participation in exercise programs may increase HDL-cholesterol and decrease the LDL-cholesterol.[24]

    The eight patients with initial high total cholesterol (TC) levels (>200mg/dL) showed (following average 5 weeks in the RGO II program) an impressive and statistically significant decrease in TC and LDL-cholesterol levels. These changes, combined with unchanged levels of HDL-cholesterol, resulted in a significant reduction of the LDL-cholesterol/HDL-cholesterol, and TC/HDL-cholesterol ratios. The beneficial changes in the lipid profile may suggest an additional advantage of the use of the RGO II in the paraplegic population and may also imply a reduced risk for coronary artery morbidity and mortality.

    Spinal cord damage and wheelchair confinement may affect the cardiovascular system, as previous studies have described a lower stroke volume and cardiac output in paraplegic patients.[25,26] This may occur due to a decreased venous return to the heart originated by a reduced vasoconstriction in the lower paralyzed limbs. In fact, it is well-known that muscular contraction in the lower extremities serves an important role in enhancing venous return flow due to their pumping action against gravity. Stimulation of the largest leg muscles, the quadriceps and hamstrings, seems to provide such venous return enhancement, as reflected by the increase in stroke volume and cardiac output. Furthermore, it was noticeable in all of the patients who used the muscle stimulation unit that profound favorable changes occurred in the legs. The thigh circumference increased and the muscle tone improved. The skin changed in appearance from pale and dry-looking to pink, moist, and healthy. Several times it was demonstrated that minor-to-moderate skin lesions (incurred by the patients during wheelchair transfers, burns from spilled liquid, etc.) healed in record time with conventional dressing. This is attributed to the increased vascularization of the muscles and the associated improvement in circulation. Undoubtedly, the increased vascularization/circulation in the thigh muscles allowed for better metabolic exchange in the skin/muscles, allowing better supply of nutritional metabolites, as well as removal of waste material.

    The general reduction of spasticity, increased strength and tone, faster healing of skin lesions, and general healthy appearance of the legs was attributed to the muscle stimulation component of the RGO II. This was noticed by the patients, many of whom favored the use of the stimulation unit several times a day without the mechanical orthosis, which was an available feature of the device.

    Respiratory Improvement

    Patients with lower thoracic and lumbar lesions, however, have little impairment of lung function.[27] The chest wall and respiratory muscles do not affect the pump that generates the power to activate the lungs and allow breathing.

    The consistent increase in stroke volume and cardiac output noticed in our patients may have originated from an improved circulation in the lower extremities that enhanced venous return.[28] The increased vital capacity (more than 10%) was associated with the upright position allowed by the walking orthosis and may improve the breathing mechanism.

    Effort Based on Heart Rate

    The improvements in the cardiopulmonary functions could not be fully attributable to the muscle stimulation component of the RGO II. Although the RGO II was shown to provide significant decrease in the activity and energy expenditure of the upper extremities,[9] a moderate level of activity was still required from the upper body to ambulate with the RGO II. This upper-body activity was above the activity level of the patients seated in a wheelchair and constituted an exercise. The added activity of the upper body together with the activity of the leg muscles due to stimulation was probably the reason for the general improvement in the cardiopulmonary function, as was confirmed for other stimulation conditions.[29,30]

    The heart rate values associated with locomotion with the RGO II, RGO, Parawalker, Marsolais FES system, and the Parastep provide insight into the effort associated with the use of each orthosis over a 30m distance. The data provided in Figure 13 should be qualified as one considers the variations in the conditions under which the heart rate data were collected for each orthosis. The experimental conditions for the RGO II, RGO, LLB, and Marsolais orthoses began with the patients sitting quietly for several minutes. The initial heart rate was taken, following which the patient stood up and walked a straight track of 30m. The final heart rate was taken immediately at the conclusion of the 30m walk. The data for the Parawalker was collected after the patients walked a 6.1m-long track 5 times. Heart rate was taken with the patients seated quietly, after which the patients stood up and rested until they proceeded to walk the 6.1m track, resting for 1 minute before turning around and walking the 6.1m again; they repeated this walking procedure until they accumulated a distance of 30m. The data, therefore, represent several minutes of rest after standing up and four 1-minute rests over the 30m excursion. Patients who used the Parastep walked a 5m track, then turned around and repeated the distance 6 times. The initial heart rate shown in this report was taken at the completion of the first 5m walk.

    Based on the variation in the conditions at which the data were collected for the Parawalker and Parastep, one can assume that significant periods of rest (a minimum of 5 minutes) were associated with the final heart rate presented for the Parawalker, whereas the final heart rate for the Parastep represents a reasonable estimate of the effort associated with the use of that orthosis for a 30m walk without any rest. The initial heart rate for the Parastep, however, is not comparable to that of the other orthoses, as it was taken during locomotion.

    Nevertheless, the comparison reveals an important fact: a walking orthosis composed of a mechanical brace that allows antigravity support and stability in conjunction with muscle stimulation for purposes of propagation is advantageous over a mechanical orthosis (RGO, Parawalker, and LLB) or muscle-stimulation orthosis (Marsolais and Parastep) when used separately. The data also demonstrate that mechanical walking devices such as the RGO, Parawalker, and LLB are significantly more efficient in comparison to walking orthoses based on muscle stimulation alone, eg, the Parastep and Marsolais orthoses.

    A third conclusion is that a maximal bracing orthosis, such as the hip-knee-ankle-foot orthotic design of the Parawalker and the RGO, are significantly more efficient than a minimal orthosis such as the LLB. The final heart rate associated with the RGO and the Parawalker was similar at 132 and 134 pulses/minute, respectively, whereas the LLB caused a heart rate increase of 16 pulses/minute over the Parawalker and 18 pulses/minute over the RGO.

    Finally, the muscle-stimulation orthoses (eg, the Parastep and Marsolais systems) required exceptionally high effort, demonstrated by a final heart rate of 161 and 170 pulses/minute, respectively, at the end of a 30m walk. Therefore, the use of such devices may be limited to a highly selected group of young and fit patients. It also demonstrates that the current technology of muscle stimulation as applied to the recovery of lost human locomotion is still in its infancy, and it is useful for some simple direct application, eg, in muscle reeducation and on/off control of contraction as in the RGO II, but it is far from providing an acceptable alternative to mechanical bracing when used by itself.

    Evaluation of the Results

    The data clearly represented a trend of improving physiological conditions, yet not all of it was statistically significant. Specifically, the bone metabolism, vital capacity, and cardiac output showed improvements without statistical significance. It should be noted that each patient was attending the program 3 times a week, and each session included at least 1 hour of walking. It may be possible that load-bearing combined with the upper and lower body exercise associated with locomotion in the RGO II for 3 to 4 hours a week was having a minor or moderate impact on the patient's condition, but not enough to give it statistical significance. It is conceivable that an additional hour or two a week could facilitate much more pronounced improvement in the patient's physiological conditions, especially on the reversal of the osteoporosis of the leg bones, as it is well-established that such reversal is lengthy and requires the application of substantial exercise.

    The combined percentage of patients who reported improvement in spasticity due to the RGO II treatment was 76%. Although the improvement was not surprising, as it had been reported before by Bajd and colleagues,[31,32] the degree and length of relief from spasms in our patients was higher. The primary reason for the larger improvement in our patients is probably due to each patient assessing his or her spastic episodes over a 24-hour period as opposed to an isolated test of relatively short duration. Second, together with the stimulation program associated with the RGO II, our patients walked for 3 to 4 hours daily. This added the factor of the lower-extremity joints going through their range of motion, which is also known to reduce spasticity.

    Conclusion

    The muscle-stimulation-powered orthosis and associated training necessary for the paraplegic patients to accomplish locomotion resulted in a decrease in bone resorption, beneficial changes in lipid profile, reduced spasticity, and some improvements in the cardiopulmonary system. These results, however, were accomplished with a relatively short period of training and suggest that more prolonged use of the RGO II will further benefit the cardiopulmonary mechanisms of paraplegics.
    References

    Chantraine A, Crielaard JM, Onkelinx A, et al: Energy expenditure of ambulation in paraplegics: effects of long term use of bracing. Paraplegia 22:173-181, 1984.
    Clinkingbeard JR, Gersten JW, Hoehn D: Energy cost of ambulation in traumatic paraplegia. Am J Phys Med 43:157-165, 1964.
    Gordon EE, Vanderwalde H: Energy requirements in paraplegic ambulation. Arch Phys Med Rehabil 37:276-285, 1956.
    Huang C-T, Kuhlemeier KV, Moore NB, et al: Energy cost of ambulation in paraplegic patients using Craig-Scott braces. Arch Phys Med Rehabil 60:595-600, 1979.
    Merkel KD, Miller NE, Westbrook PR, et al: Energy expenditure of paraplegic patients standing and walking with two knee-ankle-foot orthoses. Arch Phys Med Rehabil 65:121-124, 1984.
    Whittle M, Cochrane G. A Comparative Trial of the Hip Guidance Orthosis and the Reciprocating Gait Orthosis. Nuffield Orthopedic Center, Oxford, England: Department of Health and Social Security, 1988:1-54.
    Rose G. The principles and practice of hip guidance articulation. Prosthet Orthot Int 3:37-43, 1979.
    Nene AV, Patrick JH: Energy cost of paraplegic locomotion with the ORLAU ParaWalker. Paraplegia 27:5-18, 1989.
    Solomonow M, Baratta RV, Hirokawa S, et al: The RGO Generation II: muscle stimulation powered orthosis as a practical walking system for thoracic paraplegics. Orthopedics 12:1309-1315, 1989.
    Solomonow M: Biomechanics and electrophysiology of a practical FNS powered walking orthosis for paraplegics. In: Neural Prostheses. Stein R, Peckham H, eds.Oxford, England: Oxford Press, 1992.
    Hirokawa S, Grimm M, Le T, et al: Energy consumption in paraplegics ambulation using the reciprocating gait orthosis and electric stimulation of thigh muscles. Arch Phys Med and Rehabil 71:687-694, 1990.
    Solomonow M, Aguilar E, Reisin E, et al: Reciprocating gait orthosis powered with electrical muscle stimulation (RGO 11). Part 1: Performance and medical evaluation of 70 paraplegic patients. Orthopedics 20:315-324, 1997.
    Solomonow M, Reisin E, Aguilar E, et al: Reciprocating gait orthosis powered with electrical muscle stimulation (RGO II). Part II: Medical evaluation of 70 paraplegic patients. Orthopedics 20:411-418, 1997.
    Chantraine A, Nusgens B, Ispiere CM: Bone remodeling during the development of osteoporosis in paraplegics. Calcif Tissue Int 38:323-327, 1986.
    Rubin SM, Cummings SR: Results of bone densitometry affect women's decisions about taking measures to prevent fractures. Annals Intern Med 116:990-995, 1992.
    Nene AV, Jennings SJ: Physiological cost index of paraplegic locomotion using the Orlau Parawalker. Paraplegia 30:246-252, 1992.
    Marsolais EB, Edwards BG: Energy costs of walking and standing with functional neuromuscular stimulation and long leg braces. Arch Phys Med Rehabil 69:243-249, 1988.
    Winchester P, Carollo J, Habasevich R: Physiologic costs of reciprocal gait in FES assisted walking. Paraplegia32:680-686, 1994.
    Jaeger R, Yarkony G, Roth E, et al: Estimating the user population of a single electrical stimulation system for standing. Paraplegia 28:505-511, 1990.
    Chantraine A, Van Ouwenaller C, Hachen HJ, et al: Intramedullary pressure and intra-osseous phlebography in paraplegia. Paraplegia 17:391-397, 1979.
    Hooker SP, Wells CL: Effects of low and moderate intensity training in spinal cord injured persons. Med Sci Sports Exerc 21:18-22, 1989.
    Gordon T, Coustelli WP, Jortland MC, et al: High density lipoprotein as a protective factor against coronary artery disease. Am J Med 62:707-714, 1977.
    Gordon T, Coustelli WP, Jortland MC, et al: Lipoprotein cardiovascular disease and death. The Framingham Study. Arch Intern Med. 141:1128-1131, 1981.
    Troy ZV, Weltmetr A, Glass GV, et al: The effect of exercise on blood lipids and lipoproteins. A metorolysis of studies. Med Sci Sports Exerc 15:393-402, 1983.
    Kessler KM, Pina I, Green B, et al: Cardiovascular findings in quadriplegic and paraplegic patients and in normal subjects. Am J Cardiol 58:525-530, 1986.
    Van Loan MD, McCleur S, Loftin M, et al: Comparison of physiological responses to maximal arm exercise among able-bodied, paraplegic and quadriplegic subjects. Paraplegia 25:397-405, 1987.
    Morgan MDL, Silver J, Williams S: The respiratory system of the spinal cord patient. Management of the Spinal Cord Patient. Block RF, Basbaum M, eds. Baltimore: William and Wilkins; pp. 78-116, 1986.
    Kinzer M, Convertino VA: Role of leg musculature in the cardiovascular response to arm work in wheelchair-dependent populations. Clin Physiol 9:525-533, 1989.
    Glasser RM: Physiological aspects of spinal cord injury and functional electrical stimulation. Central Nervous System Trauma 3:49-62, 1986.
    Davis GM, Servidio FJ, Glaser RM, et al: Cardiovascular response to arm cranking and FNS induced leg exercise in paraplegia. J Appl Physiol 69:671-677, 1990.
    Bajd T, Bowman B: Testing and modeling of spasticity. J Biomedical Engineering 69:9-16, 1984.
    Bajd T, Gregori M, Vodovnik L, et al: Electrical stimulation in treating spasticity resulting from spinal cord injury. Arch Phys Med Rehabil 66:515-517, 1985.
    Acknowledgements
    This work was supported by an LEQSF grant from the Louisiana Board of Regents. The authors wish to thank Dr. Y. Lu and orthotists N. Rightor and W. Walker for their contributions and assistance throughout the project.


    Dr. Solomonow is Professor and Director of Bioengineering, Dr. Aguilar is Director of Informatics, Dr. Reisin is Professor of Orthopedics, Dr. Baratta is Associate Professor of Orthopedics, and Dr. D'Ambrosia is Professor and Chairman of Orthopedic Surgery at Louisiana State University Medical Center, New Orleans, La.


    Solomonow M, Aguilar E, Reisin E, Baratta RV, D'Ambrosia R. Evaluation of 70 Paraplegic Patients Treated With the Reciprocating Gait Orthosis Powered by Muscle Stimulation. MedGenMed 1(3), 1999 [formerly published in Medscape Orthopaedics & Sports Medicine eJournal 3(3), 1999]. Available at: http://www.medscape.com/viewarticle/408503

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