NCT00006429

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 1999

Longer than P75 for phase_2

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2000

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

September 26, 2016

Status Verified

May 1, 2011

Enrollment Period

4.9 years

First QC Date

November 1, 2000

Last Update Submit

September 23, 2016

Conditions

Spinal Cord Injury

Keywords

Spinal Cord InjuryBody Weight Supported Ambulation TrainingTreadmill TrainingPhysical therapyGaitAssisted Ambulation

Interventions

body weight-supported treadmill trainingPROCEDURE

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Rancho Los Amigos Medical Center

Downey, California, 90242, United States

Location

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Six Franklin Plaza

Philadelphia, Pennsylvania, 19102, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

University of Ottawa

Ottawa, Ontario, K1H 8M2, Canada

Location

McGill University

Montreal, Quebec, H3G 1Y5, Canada

Location

Related Publications (3)

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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 14503436BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Bruce H. Dobkin, MD

    University of California at Los Angeles (UCLA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

November 1, 2000

First Posted

November 2, 2000

Study Start

March 1, 1999

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

September 26, 2016

Record last verified: 2011-05

Locations

US(5)CA(2)