Full Text View
Tabular View
No Study Results Posted
Related Studies
Treadmill Training for Spinal Cord Injury
This study is ongoing, but not recruiting participants.
Study NCT00006429   Information provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First Received: November 1, 2000   Last Updated: February 21, 2007   History of Changes

November 1, 2000
February 21, 2007
March 1999
 
 
 
Complete list of historical versions of study NCT00006429 on ClinicalTrials.gov Archive Site
 
 
 
Treadmill Training for Spinal Cord Injury
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.

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.

Phase II
Interventional
Educational/Counseling/Training, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study
Spinal Cord Injury
Procedure: body weight-supported treadmill training
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
200
February 2004
 

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
Both
16 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00006429
 
NICHD-0103, U01 HD37439
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 
Principal Investigator: Bruce H. Dobkin, MD University of California at Los Angeles (UCLA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
November 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP