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.

Condition	Treatment or Intervention	Phase
Spinal Cord Injury	Procedure: body weight-supported treadmill training	Phase II

Further Study Details: 

Expected Total Enrollment:  200

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.

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

Criteria

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

California
      Rancho Los Amigos Medical Center, Downey,  California,  90242,  United States
Georgia
      Shepherd Center, Atlanta,  Georgia,  30309,  United States
Ohio
      Ohio State University, Columbus,  Ohio,  43210,  United States
Pennsylvania
      Thomas Jefferson University Hospital, Philadelphia,  Pennsylvania,  19107,  United States
      Six Franklin Plaza, Philadelphia,  Pennsylvania,  19102,  United States
Canada, Ontario
      University of Ottawa, Ottawa,  Ontario,  K1H 8M2,  Canada
Canada, Quebec
      McGill University, Montreal,  Quebec,  H3G 1Y5,  Canada

Study chairs or principal investigators

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

Study ID Numbers:  NICHD-0103; U01 HD37439
Record last reviewed:  November 2004
Last Updated:  November 29, 2004
Record first received:  November 1, 2000
ClinicalTrials.gov Identifier:  NCT00006429
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08