Physical Work Capacity After Traumatic Brain Injury

This study is currently recruiting participants.

Verified by The University of Texas, Galveston, August 2008

Sponsors and Collaborators:	The University of Texas, Galveston Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	The University of Texas, Galveston
ClinicalTrials.gov Identifier:	NCT00653640

Purpose

The purpose of this study is to determine whether body weight support 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

MedlinePlus related topics: Traumatic Brain Injury

Drug Information available for: Amphetamine Methamphetamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Physical Work Capacity After Traumatic Brain Injury

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 ]

Estimated Enrollment:	40
Study Start Date:	May 2006
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental body weight supported treadmill training	Procedure: body weight supported treadmill training BWSTT for 12 weeks, 3 times per week
2: Placebo Comparator 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

Contacts

Contact: Kurt A Mossberg, PT, PhD	409-772-3069	kmossber@utmb.edu
Contact: Paula Skinkis, MEd	409-772-9520	pskinkis@utmb.edu

Locations

United States, Texas
Transitional Learning Center	Recruiting
Galveston, Texas, United States, 77550
Contact: Kurt A Mossberg, PT, PhD 409-772-3069 kmossber@utmb.edu

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 of Results:

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.

Other Publications:

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.

Responsible Party:	The University of Texas Medical Branch ( Kurt A. Mossberg, PT, PhD )
Study ID Numbers:	98-367, R01 HD046570
Study First Received:	April 1, 2008
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00653640
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

Study placed in the following topic categories:

Craniocerebral Trauma
Methamphetamine
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases

Amphetamine
Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009