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Physical Work Capacity After Traumatic Brain Injury

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Kurt Mossberg, The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00653640
First received: April 1, 2008
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Traumatic Brain Injury
 Procedure: body weight supported treadmill training
Procedure: traditional physical therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Physical Work Capacity After Traumatic Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Overground gait speed [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • aerobic capacity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: May 2006
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653640

Locations
United States, Texas
Transitional Learning Center
Galveston, Texas, United States, 77550
TIRR Memorial Hermann
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas, Galveston
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Kurt A. Mossberg, PT, PhD University of Texas, Galveston
  More Information

Publications:

Responsible Party: Kurt Mossberg, Professor, The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00653640     History of Changes
Other Study ID Numbers: 98-367, R01 HD046570
Study First Received: April 1, 2008
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:
rehabilitation
head injury
3 months post injury
 require manual assistance or walking aids to walk
very slow walking speed
able to follow two step commands

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013