Treadmill Training for Spinal Cord Injury

Phase 2

Completed

• Conditions: Spinal Cord Injury

• Registration Number: NCT00006429
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 1999-03
• Study First Submitted: 2000-11-01
• Study First Submitted QC: 2000-11-01
• Study First Posted: 2000-11-02
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Status Verified: 2011-05
• Last Update Submitted: 2016-09-23
• Last Update Posted: 2016-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (7)

Rancho Los Amigos Medical Center; 🇺🇸 Downey, California, United States

Shepherd Center; 🇺🇸 Atlanta, Georgia, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Six Franklin Plaza; 🇺🇸 Philadelphia, Pennsylvania, United States

McGill University; 🇨🇦 Montreal, Quebec, Canada

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Ottawa; 🇨🇦 Ottawa, Ontario, Canada