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Physical Work Capacity After Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
body weight supported treadmill training
traditional physical therapy
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring 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

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Transitional Learning Center
  • TIRR Memorial Hermann

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

body weight supported treadmill training

traditional physical therapy

Outcomes

Primary Outcome Measures

Overground gait speed

Secondary Outcome Measures

aerobic capacity

Full Information

First Posted
April 1, 2008
Last Updated
July 9, 2018
Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00653640
Brief Title
Physical Work Capacity After Traumatic Brain Injury
Official Title
Physical Work Capacity After Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
body weight supported treadmill training
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
traditional physical therapy
Intervention Type
Procedure
Intervention Name(s)
body weight supported treadmill training
Intervention Description
BWSTT for 12 weeks, 3 times per week
Intervention Type
Procedure
Intervention Name(s)
traditional physical therapy
Intervention Description
traditional PT for 12 weeks, 3 times per week
Primary Outcome Measure Information:
Title
Overground gait speed
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
aerobic capacity
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt A. Mossberg, PT, PhD
Organizational Affiliation
University of Texas, Galveston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Transitional Learning Center
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
TIRR Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17321823
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.
Results Reference
background
PubMed Identifier
15973085
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.
Results Reference
background
PubMed Identifier
12704280
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.
Results Reference
background
PubMed Identifier
12217204
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. Erratum In: Brain Inj. 2003 Mar;17(3):266.
Results Reference
background
PubMed Identifier
18413421
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.
Results Reference
background
PubMed Identifier
18594990
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.
Results Reference
background
PubMed Identifier
20473091
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.
Results Reference
background
PubMed Identifier
17940106
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.
Results Reference
result
PubMed Identifier
22282772
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.
Results Reference
result

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Physical Work Capacity After Traumatic Brain Injury

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