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NCT00653640 Clinical Trial

Physical Work Capacity After Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:
Physical Work Capacity After Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00653640
Other study ID # 98-367
Secondary ID R01HD046570
Status Completed
Phase N/A
First received
Last updated
Start date May 2006
Est. completion date March 2012

Study information
Verified date June 2012
Source The University of Texas Medical Branch, Galveston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• body weight supported treadmill training
BWSTT for 12 weeks, 3 times per week
• traditional physical therapy
traditional PT for 12 weeks, 3 times per week

Locations
Country Name City State
United States Transitional Learning Center Galveston Texas
United States TIRR Memorial Hermann Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
The University of Texas Medical Branch, Galveston Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Overground gait speed 12 weeks
Secondary aerobic capacity 12 weeks
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