Treadmill Training for Spinal Cord Injury

Completed · Phase 2

Conditions studied: Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT00006429

Run by

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

People needed

200

Starts

1999-03-01

Expected to finish

2004-02-01

Last updated by the study team

2016-09-26

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• University of Ottawa — Ottawa, Ontario, Canada
• McGill University — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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