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Physical Work Capacity After Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00653640
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief Summary:
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 or disease Intervention/treatment Phase
Traumatic Brain Injury Procedure: body weight supported treadmill training Procedure: traditional physical therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Work Capacity After Traumatic Brain Injury
Study Start Date : May 2006
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Overground gait speed [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. aerobic capacity [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653640


Locations
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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 Medical Branch, Galveston
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Kurt A. Mossberg, PT, PhD University of Texas, Galveston
Publications of Results:
Other Publications:
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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00653640    
Other Study ID Numbers: 98-367
R01HD046570 ( U.S. NIH Grant/Contract )
First Posted: April 7, 2008    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: June 2012
Keywords provided by The University of Texas Medical Branch, 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:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System