Treadmill Training for Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Locomotor Therapy Trial for Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006429
• Other study ID #: NICHD-0103
• Secondary ID: U01HD037439
• Status: Completed
• Phase: Phase 2
• First received: November 1, 2000
• Last updated: September 23, 2016
• Start date: March 1999
• Est. completion date: February 2004

Study information

• Verified date: May 2011
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Procedure:
• body weight-supported treadmill training

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

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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