Physical Work Capacity After Traumatic Brain Injury

July 9, 2018 updated by: The University of Texas Medical Branch, Galveston
The purpose of this study is to determine whether body weight supported treadmill training is more effective than traditional physical therapy at restoring gait in persons recovering from traumatic brain injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77550
        • Transitional Learning Center
      • Houston, Texas, United States, 77030
        • TIRR Memorial Hermann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • traumatic brain injury
  • follow two step commands
  • between 18 and 60 years old
  • between 3 and 36 months post injury

Exclusion Criteria:

  • known cardiovascular disease
  • uncooperative, behavioral challenges

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
body weight supported treadmill training
Procedure: body weight supported treadmill training
BWSTT for 12 weeks, 3 times per week
Placebo Comparator: 2
traditional physical therapy
Procedure: traditional physical therapy
traditional PT for 12 weeks, 3 times per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overground gait speed
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
aerobic capacity
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Kurt A. Mossberg, PT, PhD, University of Texas, Galveston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 1, 2008

First Posted (Estimate)

April 7, 2008

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

July 9, 2018

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-367
  • R01HD046570 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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