Purpose

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.

Condition	Treatment or Intervention	Phase

Spinal Cord Injury

 Procedure: body weight-supported treadmill training

Phase II

MEDLINEplus related topics:  Spinal Cord Injuries

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study

Official Title: Locomotor Therapy Trial for Spinal Cord Injury

Further Study Details: 

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.

Eligibility

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

Criteria

 

Inclusion Criteria:

• Traumatic spinal cord injury (within 35 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

Expected Total Enrollment:  200

Location and Contact Information

Bruce Dobkin       

California

 

Rancho Los Amigos Medical Center, Downey,   California,   90242,   United States; Recruiting

   Claire Beekman   

Georgia

 

Shepherd Center, Atlanta,   Georgia,   30309,   United States; Recruiting

 

North Dakota

 

Ohio State University, Columbus,   North Dakota,   43210,   United States; Recruiting

   Ann M. Smith   

Pennsylvania

 

Thomas Jefferson University Hospital, Philadelphia,   Pennsylvania,   19107,   United States; Recruiting

   Mary Call   

 

Six Franklin Plaza, Philadelphia,   Pennsylvania,   19102,   United States; Recruiting

   Mary Schmidt   

Canada, Ontario

 

University of Ottawa, Ottawa,   Ontario,   K1H 8M2,   Canada; Recruiting

   Michele Badour   

Canada, Quebec

 

Magill University, Montreal,   Quebec,   H3G 1Y5,   Canada; Recruiting

   Christine Garneau   

Study chairs or principal investigators

Bruce H. Dobkin, MD,  Principal Investigator

University of California at Los Angeles (UCLA)   

More Information

Click here for more information about NICHD clinical trials.

Publications

Dobkin, B. "Recovery of Locomotor Control". The Neurologist 1996:239-249.

Study ID Numbers  NICHD-0103;  U01 HD37439

Date study started March 1999;  Study Completion Date  February 2004

Record last reviewed  March 2000

NLM Identifier  NCT00006429

ClinicalTrials.gov processed this record on 2002-10-31