Treadmill Training for Spinal Cord Injury

September 23, 2016 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1999

Primary Completion (Actual)

February 1, 2004

Study Completion

February 1, 2004

Study Registration Dates

First Submitted

November 1, 2000

First Submitted That Met QC Criteria

November 1, 2000

First Posted (Estimate)

November 2, 2000

Study Record Updates

Last Update Posted (Estimate)

September 26, 2016

Last Update Submitted That Met QC Criteria

September 23, 2016

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NICHD-0103
  • U01HD037439 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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