NIH Multicenter Trial to Assess Treadmill Training for Spinal Cord Injury [Archive]

Wise Young

08-06-2001, 01:03 AM

http://clinicaltrials.gov/ct/gui/c/a1b/show/NCT00006429?order=6&JServSessionId zone_ct=zhn5b9gan1 (http://clinicaltrials.gov/ct/gui/c/a1b/show/NCT00006429?order=6&JServSessionIdzone_ct=zhn5b9gan1)

Treadmill Training for Spinal Cord Injury

This study is currently recruiting patients.

Sponsored by

National Institute of Child Health and Human Development (NICHD)

Purpose

This is a trial to test whether treadmill training can be used to improve the "walking" of patients with partial spinal cord injury. While on the treadmill, patients will be partially supported through the use of a specially designed harness attached to an overhead lift (also called Body Weight Supported Treadmill Training, BWSTT). Patients who enroll in this study will be randomly assigned to either the experimental group, which receives 12 weeks of this specialized treadmill training with regular physical therapy, or to the control group, which receives 12 weeks regular physical therapy. The ability of the patients to "walk" will be measured before and after treatment as well as 6 and 12 months later, using standard tests that examine mobility independence and speed of ambulation. The trial takes place across five sites in the US and Canada.

Condition Treatment or Intervention Phase Spinal Cord Injury

Procedure:body weight-supported treadmill training

Phase II

MEDLINEplusrelated topics:SpinalCordInjuries

Study Type:Interventional
Study Design:Educational/Counseling/Training,Randomized,Single Blind,Active Control,Efficacy Study,Single Group Assignment

Official Title:Locomotor Therapy Trial for Spinal Cord Injury

Further Study Details:

This is a 5-site randomized clinical trial of a task-oriented locomotor intervention for acute spinal cord injury (SCI). The intervention, body weight-supported treadmill training (BWSTT), partially supports the weight of the patient via an overhead lift attached to a harness. Therapists train the patient to walk on a treadmill by correcting gait deviations and manipulating sensory input that enhance control of the stance and swing phases of walking at increasingly higher speeds and less weight support. 100 patients with incomplete SCI (from below C4 to T10/11) and 100 patients with lesions at T12 to L3 will be randomly assigned to 12 weeks of conventional therapy programs for mobility versus the same intensity and duration of a combination of conventional therapy plus BWSTT. The primary outcome measures are the level of independence for ambulation and the maximal speed for walking 50 feet. Patients will be tested by masked examiners before and after the 12 weeks of therapy, and 6 and 12 months after entry into the study.

Eligibility

Ages Eligible for Study: 16 Years - 65 Years, Genders Eligible for Study: Both

Participants: Patients

Criteria

Inclusion Criteria:
* Traumatic spinal cord injury (within 35 days) * Incomplete lesion: - ASIA C or D, from below C4 to L3 - ASIA B at or below C7 * Unable to ambulate over ground without at least moderate assistance (FIM locomotor 3 or less) * Able to offer at least 3/5 strength in elbow extensors * No clinically-significant cognitive impairment

Exclusion Criteria:
* Symptomatic fall in blood pressure greater than 30 mm Hg when upright * Halo or other cervical brace or TLSO (unless primary surgeon agrees) * Contraindication to weight bearing on lower extremities * Pressure sore with any skin breakdown below level of the SCI * Any debilitating disease prior to the acute SCI that would cause exercise intolerance * Premorbid, ongoing major depression or psychosis * Required use of anti-spasticity medication * Subject unlikely to complete intervention or return for follow-up

Expected Total Enrollment: 200

Location and Contact Information

Bruce Dobkin 1-310-306-6500 bdobkin@ucla.edu

Ontario,Canada
University of Ottawa,Ottawa, Ontario, K1H 8M2, Canada;Recruiting

Michele Badour 1-613-737-7350 mdadour@rohcg.on.ca

Quebec,Canada
Magill University,Montreal, Quebec, H3G 1Y5, Canada;Recruiting

Christine Garneau 1-514-340-2090

California
Rancho Los Amigos Medical Center,Downey, California, 90242, United States;Recruiting

Claire Beekman 562-401-6244 cheekman@dhs.co.la.ca.us

Georgia
Shepard Center,Atlanta, Georgia, 30309, United States;Recruiting North Dakota
Ohio State University,Columbus, North Dakota, 43210, United States;Recruiting

Ann M. Smith 614-293-3809 smith.270@osu.edu

Pennsylvania
Thomas Jefferson University Hospital,Philadelphia, Pennsylvania, 19107, United States;Recruiting

Mary Call 215-955-6579 mary.call@mail.tju.edu

Pennsylvania
Six Franklin Plaza,Philadelphia, Pennsylvania, 19102, United States;Recruiting

Mary Schmidt 215-587-3151 mschmidt@mageerehab.org

Study chairs or principal investigators

Bruce H. Dobkin, MD, Principal Investigator University of California at Los Angeles (UCLA)

More Information

Click here for more information about NICHD clinical trials.

Publications

Dobkin, B. "Recovery of Locomotor Control". The Neurologist 1996:239-249.

Dobkin, B. "An Overview of Treadmill Locomotor Training with Patrial Body Weight Support: A Neurologically Sound Approach Whose Time Has Come for Randomized Clinical Trials," Neurorehabilitation and Neuronal Repair, 1999 13(3):157-165.

Study ID Numbers NICHD-0103; U01 HD37439
NLM Identifier NCT00006429

Date study startedMarch 1999; Date Study Completed February 2004 Record last reviewed March 2000

[This message was edited by Wise Young on August 06, 2001 at 12:39 PM.]

Wise Young

01-07-2002, 11:01 AM

1. Field-Fote EC (2001). Combined use of body weight support, functional electric stimulation, and treadmill training to improve walking ability in individuals with chronic incomplete spinal cord injury. Arch Phys Med Rehabil. 82 (6): 818-24. Summary: OBJECTIVE: To assess the effect of an intervention combining body weight support (BWS), functional electric stimulation (FES), and treadmill training on overground walking speed (OGWS), treadmill walking speed, speed and distance, and lower extremity motor scores (LEMS). DESIGN: Before and after comparison. SETTING: Miami Project to Cure Paralysis. PARTICIPANTS: Nineteen subjects with American Spinal Injury Association class C injury who were at least 1 year postinjury and had asymmetrical lower extremity function. INTERVENTION: Subjects trained 1.5 hours per day, 3 days per week, for 3 months. The training consisted of body weight-supported treadmill walking assisted by electric stimulation. Stimulation was applied to common peroneal nerve of the weaker lower extremity (LE) and timed to assist with the swing phase of the step cycle. MAIN OUTCOME MEASURES: OGWS in the absence of both BWS and FES; LEMS, and treadmill training parameters of speed and distance. RESULTS: Over the course of training, there was a significant increase in OGWS (from.12 +/- 0.8m/s to .21 +/- .15m/s, p = .0008), treadmill walking speed (from .23 +/- .12m/s to.49 +/- .20m/s, p = .00003), and treadmill walking distance (from 93 +/- 84m to 243 +/- 139m, p = .000001). The median LEMS increased significantly for both the stimulated and nonstimulated leg (from 8 to 11 in the FES-assisted leg, from 15 to 18 in the nonassisted leg, p < .005 for each). CONCLUSIONS: All subjects showed improvement in OGWS and overall LE strength. Further research is required to delineate the essential elements of these particular training strategies. <http://www.mosby.com/scripts/om.dll/serve?action=searchDB&searchDBfor=art&artType=abs&id=aapmr0820818&target=
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11387589> Division of Physical Therapy and the Miami Project to Cure Paralysis, University of Miami School of Medicine, Miami, FL, USA. edee@miami.edu

2. Protas EJ, Holmes SA, Qureshy H, Johnson A, Lee D and Sherwood AM (2001). Supported treadmill ambulation training after spinal cord injury: a pilot study. Arch Phys Med Rehabil. 82 (6): 825-31. Summary: OBJECTIVES: To conduct a pilot study of weight-supported ambulation training after incomplete spinal cord injury (SCI), and to assess its safety. DESIGN: Quasiexperimental, repeated measures, single group. SETTING: Veterans Affairs medical center. PATIENTS: Three subjects with incomplete, chronic, thoracic SCIs; 2 classified as D on the American Spinal Injury Association (ASIA) impairment scale and 1 as ASIA impairment scale C. INTERVENTION: Subjects participated in 12 weeks of training assisted by 2 physical therapists. The training consisted of walking on a treadmill while supported by a harness and a pneumatic suspension device. Support started at 40% of body weight and a treadmill speed of.16kmph, and progressed by reducing support and increasing treadmill speed and continuous treadmill walking time up to 20 minutes. Training was conducted for 1 hour per day, 5 days per week for 3 months. Treadmill walking occurred for 20 minutes during the sessions. MAIN OUTCOME MEASURES: Gait function (speed, endurance, walking status, use of assistive device and orthotics); oxygen costs of walking; brain motor control assessment; self-report indices; ASIA classification; muscle function test; and safety. RESULTS: All 3 subjects increased gait speed (.118m/s initially to.318m/s after training 12wk), and gait endurance (20.3m/5min initially to 63.5m/5min). The oxygen costs decreased from 1.96 to 1.33mL x kg(-1) x m(-1) after 12 weeks of training. CONCLUSIONS: This pilot study suggests that supported treadmill ambulation training can improve gait for individuals with incomplete SCIs by using objective gait measures. The self-report indices used have promise as patient-centered outcome measures of this new form of gait training. A larger, controlled study of this technique is warranted. <http://www.mosby.com/scripts/om.dll/serve?action=searchDB&searchDBfor=art&artType=abs&id=aapmr0820825&target=
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11387590> School of Physical Therapy, Texas Woman's University, Houston 77030-2897, USA. hf_protas@twu.edu

3. Trimble MH, Behrman AL, Flynn SM, Thigpen MT and Thompson FJ (2001). Acute effects of locomotor training on overground walking speed and H-reflex modulation in individuals with incomplete spinal cord injury. J Spinal Cord Med. 24 (2): 74-80. Summary: OBJECTIVE: The purpose of this study was to assess the effect of a single bout of a locomotor-training paradigm on overground walking speed and H-reflex modulation of individuals with incomplete spinal cord injury (SCI). METHODS: Self-selected and maximum walking speeds and soleus H-reflexes (H/M ratios) during standing and stance and swing phases of walking (self-selected velocity) were obtained from 4 individuals with American Spinal Injury Association impairment classification D. Data were collected immediately before and after a single bout of locomotor training with body weight support on a treadmill. The pretraining H/M ratios of the SCI subjects were also compared with values from 4 able-bodied subjects who did not receive the intervention. Maximum H/M ratios while standing and during midstance and midswing phases of overground walking were considerably greater in the SCI subjects than in the control subjects. RESULTS: After the single bout of training, self-selected and maximum overground walking speeds of the subjects with SCI increased by 26% and 25%, respectively. Furthermore, H-reflexes were significantly more depressed in the SCI subjects during overground walking (28% less during stance, 34% less during swing). CONCLUSIONS: Although preliminary, these findings indicate that a single bout of locomotor training produced immediate increases in walking velocity and acute neurophysiologic changes in individuals with incomplete SCI. <http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11587422> Department of Physical Therapy, University of Florida, Gainesville, USA.

4. Behrman AL and Harkema SJ (2000). Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 80 (7): 688-700. Summary: Many individuals with spinal cord injury (SCI) do not regain their ability to walk, even though it is a primary goal of rehabilitation. Mammals with thoracic spinal cord transection can relearn to step with their hind limbs on a treadmill when trained with sensory input associated with stepping. If humans have similar neural mechanisms for locomotion, then providing comparable training may promote locomotor recovery after SCI. We used locomotor training designed to provide sensory information associated with locomotion to improve stepping and walking in adults after SCI. Four adults with SCIs, with a mean postinjury time of 6 months, received locomotor training. Based on the American Spinal Injury Association (ASIA) Impairment Scale and neurological classification standards, subject 1 had a T5 injury classified as ASIA A, subject 2 had a T5 injury classified as ASIA C, subject 3 had a C6 injury classified as ASIA D, and subject 4 had a T9 injury classified as ASIA D. All subjects improved their stepping on a treadmill. One subject achieved overground walking, and 2 subjects improved their overground walking. Locomotor training using the response of the human spinal cord to sensory information related to locomotion may improve the potential recovery of walking after SCI. <http://199.100.187.254/pt_journal/PTJournal/July2000/v80n7p688.html
http://199.100.187.254/pt_journal/July00/public/v80n7p688-abs.html
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=10869131> Department of Physical Therapy and University of Florida Brain Institute, University of Florida, Gainesville 32510-0154, USA. abehrman@hp.ufl.edu

5. Gazzani F, Bernardi M, Macaluso A, Coratella D, Ditunno JF, Jr., Castellano V, Torre M, Macellari V and Marchetti M (1999). Ambulation training of neurological patients on the treadmill with a new Walking Assistance and Rehabilitation Device (WARD). Spinal Cord. 37 (5): 336-44. Summary: STUDY DESIGN: Patients with neurological walking impairment were rehabilitated with a new system, consisting of an apparatus to constantly relieve the body weight and a treadmill: The Walking Assistance and Rehabilitation Device (WARD). Patients were evaluated before and after rehabilitation with clinical scales and physiological measurements. OBJECTIVES: To evaluate the effectiveness of the WARD in improving walking capability in these patients. SETTING: The study was carried out in a clinical environment (IRCCS S. Lucia, Rehabilitation Hospital, Rome, Italy). METHODS: Seven patients (six with spinal cord injuries, one with brain injury) underwent a 1 - 2 month training period with the WARD. During the WARD training the body weight constant unloading (BWCU) applied to the patient through the WARD was regularly evaluated. Oxygen consumption, carbon dioxide production and heart rate were measured in order to obtain energy and cardiac costs of walking. These measurements were carried out while walking with the WARD at an appropriate treadmill speed (ATS) and in the open field at the most comfortable speed (MCS). All measurements, in addition to clinical scores related to the walking capability, were carried out at the beginning of the WARD training period (BWT) and at the end (EWT). At the EWT the patients were tested walking with the WARD observing the same BWT conditions (same ATS and BWCU), referred to as beginning conditions second measurements (BCSM). The relationships between physiological costs and ATS were described through second order polynomial regression curves and studied. RESULTS: Comparing the data obtained at the BWT and EWT, the following results were found significantly different: (1) Clinical scores improved; (2) All patients increased their ATS; (3) The BWCU was reduced; (4) The Walking Energy Cost (WEC) and the Walking Cardiac Cost (WCC) measured when walking with the WARD at the ATS improved in all patients; and (5) The WEC and WCC measured in the open field improved in all patients. The WEC vs ATS curve found at the EWT in the BCSM was found significantly different from the BWT curve, demonstrating a major improvement due to the WARD training. CONCLUSION: Despite some limitations due to sample size and functional ambulation scale, this study has demonstrated that the WARD training is effective in improving the walking capability and efficiency of the patients. <http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=10369170> Lab. di Ingegneria Biomedica, Istituto Superiore di Sanita, Rome, Italy.

6. Trimble MH, Kukulka CG and Behrman AL (1998). The effect of treadmill gait training on low-frequency depression of the soleus H-reflex: comparison of a spinal cord injured man to normal subjects. Neurosci Lett. 246 (3): 186-8. Summary: H-Reflex recruitment curves were obtained at 0.1 and 1 Hz in the right soleus of an incomplete SCI man before and after training and on 12 neurologically normal individuals. Low frequency depression (LFD) was calculated by the formula: 1 - (H-wave amplitude at 1 Hz/0.1 Hz) x 100. Training consisted of treadmill walking at the speed matching his overground fast walking. The subject trained for 30 min every other day for 10 days under supervision and then continued three times a week for 4 months at a health club. Maximum H/M ratio of the right soleus (78%) was greater than that of the normals (67%) and did not change following training (79%). The mean LFD of the SCI subject was 24% prior to training compared to 42% for the normal subjects. Following training, LFD increased to 35%. In addition, the reflex threshold appears to have increased following training. This was accompanied by 47 and 45% increases in the subject's self selected and fast gait velocities, respectively. We conclude that training adaptations enabled the SCI subject to increase his gait velocity due to an improved ability to gate peripheral afferent feedback during gait. <http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=9792623> Department of Physical Therapy, University of Florida, Gainesville 32610-0154, USA. mtrimble@hp.ufl.edu

7. Gardner MB, Holden MK, Leikauskas JM and Richard RL (1998). Partial body weight support with treadmill locomotion to improve gait after incomplete spinal cord injury: a single-subject experimental design. Phys Ther. 78 (4): 361-74. Summary: BACKGROUND AND PURPOSE: Gait training with partial body weight support has been used to improve gait. In this study, changes in gait relative to speed, cadence, stride length, and percentages of stance and swing for both lower extremities (LEs) during comfortable walking, fast walking, and running were studied in a subject with an incomplete C-5 on C-6 spinal cord injury. SUBJECT AND METHODS: A single-subject experimental design was used. Following a 6-week period of baseline measurements taken at various intervals (phase AI), the subject ambulated on a treadmill three times a week for 6 weeks with 32% of his body weight supported (phase B). Phase B was followed by a 3-week period without treatment during which measurements were taken at various intervals (phase AII). Gait variables were measured once a week during comfortable walking, fast walking, and running. Heart rate was monitored during treadmill training. RESULTS: During comfortable walking, fast walking, and running, improvements were seen in gait speed. During running, improvements also were seen in stride length and percentages of stance and swing for the right LE. The largest changes were recorded during running. Smaller changes were recorded during comfortable walking and fast walking. CONCLUSION AND DISCUSSION: These results justify testing the efficacy of this technique with larger groups of subjects with neurological impairments. <http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=9555919> MGH Institute of Health Professions, Boston, Mass, USA. kgard1@aol.com