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Physical Work Capacity After Traumatic Brain Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00653640
First Posted: April 7, 2008
Last Update Posted: June 20, 2012
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.
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
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Work Capacity After Traumatic Brain Injury

Resource links provided by NLM:


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

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

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

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

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
  Contacts and Locations
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
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
Principal Investigator: Kurt A. Mossberg, PT, PhD University of Texas, Galveston
  More Information

Publications:
Mossberg KA, Orlander EE, Norcross JL. Cardiorespiratory capacity after weight-supported treadmill training in patients with traumatic brain injury. Phys Ther. 2008 Jan;88(1):77-87. Epub 2007 Oct 16.
Mossberg KA, Fortini E. Responsiveness and validity of the six-minute walk test in individuals with traumatic brain injury. Phys Ther. 2012 May;92(5):726-33. doi: 10.2522/ptj.20110157. Epub 2012 Jan 26.
Mossberg KA, Ayala D, Baker T, Heard J, Masel B. Aerobic capacity after traumatic brain injury: comparison with a nondisabled cohort. Arch Phys Med Rehabil. 2007 Mar;88(3):315-20.
Mossberg KA, Greene BP. Reliability of graded exercise testing after traumatic brain injury: submaximal and peak responses. Am J Phys Med Rehabil. 2005 Jul;84(7):492-500.
Mossberg KA. Reliability of a timed walk test in persons with acquired brain injury. Am J Phys Med Rehabil. 2003 May;82(5):385-90; quiz 391-2.
Mossberg KA, Kuna S, Masel B. Ambulatory efficiency in persons with acquired brain injury after a rehabilitation intervention. Brain Inj. 2002 Sep;16(9):789-97. Erratum in: Brain Inj. 2003 Mar;17(3):266.
Mossberg KA, Masel BE, Gilkison CR, Urban RJ. Aerobic capacity and growth hormone deficiency after traumatic brain injury. J Clin Endocrinol Metab. 2008 Jul;93(7):2581-7. doi: 10.1210/jc.2008-0368. Epub 2008 Apr 15.
Beca SG, High WM Jr, Masel BE, Mossberg KA, Urban RJ. What are critical outcome measures for patients receiving pituitary replacement following brain injury? Pituitary. 2012 Mar;15(1):10-9. doi: 10.1007/s11102-008-0133-3. Review.
Mossberg KA, Amonette WE, Masel BE. Endurance training and cardiorespiratory conditioning after traumatic brain injury. J Head Trauma Rehabil. 2010 May-Jun;25(3):173-83. doi: 10.1097/HTR.0b013e3181dc98ff. Review.

Responsible Party: Kurt Mossberg, Professor, The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00653640     History of Changes
Other Study ID Numbers: 98-367
R01HD046570 ( U.S. NIH Grant/Contract )
First Submitted: April 1, 2008
First Posted: April 7, 2008
Last Update Posted: June 20, 2012
Last Verified: June 2012

Keywords provided by Kurt Mossberg, 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:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System


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