Spinal Cord Injury Clinical Trial
Official title:
Locomotor Therapy Trial for Spinal Cord Injury
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. Patients eligible for this trial will have had a traumatic spinal cord injury within 8 weeks of trial entry.
Status | Completed |
Enrollment | 200 |
Est. completion date | February 2004 |
Est. primary completion date | February 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Traumatic spinal cord injury (within 56 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind
Country | Name | City | State |
---|---|---|---|
Canada | McGill University | Montreal | Quebec |
Canada | University of Ottawa | Ottawa | Ontario |
United States | Shepherd Center | Atlanta | Georgia |
United States | Ohio State University | Columbus | Ohio |
United States | Rancho Los Amigos Medical Center | Downey | California |
United States | Six Franklin Plaza | Philadelphia | Pennsylvania |
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States, Canada,
Dobkin BH, Apple D, Barbeau H, Basso M, Behrman A, Deforge D, Ditunno J, Dudley G, Elashoff R, Fugate L, Harkema S, Saulino M, Scott M. Methods for a randomized trial of weight-supported treadmill training versus conventional training for walking during inpatient rehabilitation after incomplete traumatic spinal cord injury. Neurorehabil Neural Repair. 2003 Sep;17(3):153-67. — View Citation
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.
Dobkin, B. "Recovery of Locomotor Control". The Neurologist 1996:239-249.
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