Clinical trial NCT00653640: Physical Work Capacity After Traumatic Brain Injury
Official title: Physical Work Capacity After Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: 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
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2008-04-07
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Overground gait speed
timeFrame: 12 weeks
Secondary outcomes:
measure: aerobic capacity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Galveston
country: United States
facility: Transitional Learning Center
state: Texas
city: Houston
country: United States
facility: TIRR Memorial Hermann
state: Texas
Study officials:
affiliation: University of Texas, Galveston
name: Kurt A. Mossberg, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.apmr.2006.12.006.
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. doi: 10.1097/01.phm.0000166883.97562.cd.
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. doi: 10.1097/01.PHM.0000052589.96202.BE.
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. doi: 10.1080/02699050210131894.
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.
citation: 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.
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.
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. doi: 10.2522/ptj.20070022. Epub 2007 Oct 16.
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.