Treadmill Training for Spinal Cord Injury

This study has been withdrawn prior to enrollment.
(Study Terminated/withdrawn)
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00006429
First received: November 1, 2000
Last updated: May 20, 2011
Last verified: May 2011
  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. Patients eligible for this trial will have had a traumatic spinal cord injury within 8 weeks of trial entry.


Condition Intervention Phase
Spinal Cord Injury
Procedure: body weight-supported treadmill training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Official Title: Locomotor Therapy Trial for Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 200
Study Start Date: March 1999
Estimated Study Completion Date: February 2004
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.

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006429

Locations
United States, California
Rancho Los Amigos Medical Center
Downey, California, United States, 90242
United States, Georgia
Shepherd Center
Atlanta, Georgia, United States, 30309
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Six Franklin Plaza
Philadelphia, Pennsylvania, United States, 19102
Canada, Ontario
University of Ottawa
Ottawa, Ontario, Canada, K1H 8M2
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H3G 1Y5
Sponsors and Collaborators
Investigators
Principal Investigator: Bruce H. Dobkin, MD University of California at Los Angeles (UCLA)
  More Information

Additional Information:
Publications:
Dobkin, B. "Recovery of Locomotor Control". The Neurologist 1996:239-249.
Dobkin, B. "An Overview of Treadmill Locomotor Training with Patrial Body Weight Support: A Neurologically Sound Approach Whose Time Has Come for Randomized Clinical Trials," Neurorehabilitation and Neuronal Repair, 1999 13(3):157-165.
Cobkin, BH, Methods for a Randomized Trial of Weight-Supported Treadmill Training versus Conventional Training for Walking during Inpatient Rehabilitation after Traumatic Incomplete Spinal Cord Injury. The American Society of Neurorehabilitation,2003

ClinicalTrials.gov Identifier: NCT00006429     History of Changes
Other Study ID Numbers: NICHD-0103, U01 HD37439
Study First Received: November 1, 2000
Last Updated: May 20, 2011
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Spinal Cord Injury
Body Weight Supported Ambulation Training
Treadmill Training
Physical therapy
Gait
Assisted Ambulation

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 28, 2014