Clinical trial NCT00006429: Treadmill Training for Spinal Cord Injury
Official title: Locomotor Therapy Trial for Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Cord Injury
Keywords: Spinal Cord Injury
Body Weight Supported Ambulation Training
Treadmill Training
Physical therapy
Gait
Assisted Ambulation
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2000-11-02
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos Medical Center
state: California
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Six Franklin Plaza
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: University of California at Los Angeles (UCLA)
name: Bruce H. Dobkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dobkin, B. "Recovery of Locomotor Control". The Neurologist 1996:239-249.
citation: 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.
citation: Dobkin BH, Apple D, Barbeau H, Basso M, Behrman A, Deforge D, Ditunno J, Dudley G, Elashoff R, Fugate L, Harkema S, Saulino M, Scott M. Methods for a randomized trial of weight-supported treadmill training versus conventional training for walking during inpatient rehabilitation after incomplete traumatic spinal cord injury. Neurorehabil Neural Repair. 2003 Sep;17(3):153-67. doi: 10.1177/0888439003255508.