NCT00653640

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 11, 2018

Status Verified

June 1, 2012

Enrollment Period

5.8 years

First QC Date

April 1, 2008

Last Update Submit

July 9, 2018

Conditions

Traumatic Brain Injury

Keywords

rehabilitationhead injury3 months post injuryrequire manual assistance or walking aids to walkvery slow walking speedable to follow two step commands

Outcome Measures

Primary Outcomes (1)

  • Overground gait speed

    12 weeks

Secondary Outcomes (1)

  • aerobic capacity

    12 weeks

Study Arms (2)

1

EXPERIMENTAL

body weight supported treadmill training

Procedure: body weight supported treadmill training

2

PLACEBO COMPARATOR

traditional physical therapy

Procedure: traditional physical therapy

Interventions

body weight supported treadmill trainingPROCEDURE

BWSTT for 12 weeks, 3 times per week

1
traditional physical therapyPROCEDURE

traditional PT for 12 weeks, 3 times per week

2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • traumatic brain injury
  • follow two step commands
  • between 18 and 60 years old
  • between 3 and 36 months post injury

You may not qualify if:

  • known cardiovascular disease
  • uncooperative, behavioral challenges

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Transitional Learning Center

Galveston, Texas, 77550, United States

Location

TIRR Memorial Hermann

Houston, Texas, 77030, United States

Location

Related Publications (9)

  • 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.

    PMID: 17321823BACKGROUND

  • 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.

    PMID: 15973085BACKGROUND

  • 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.

    PMID: 12704280BACKGROUND

  • 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.

    PMID: 12217204BACKGROUND

  • 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.

    PMID: 18413421BACKGROUND

  • 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.

    PMID: 18594990BACKGROUND

  • 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.

    PMID: 20473091BACKGROUND

  • 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.

    PMID: 17940106RESULT

  • 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.

    PMID: 22282772RESULT

MeSH Terms

Conditions

Brain Injuries, TraumaticCraniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Kurt A. Mossberg, PT, PhD

    University of Texas, Galveston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 7, 2008

Study Start

May 1, 2006

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 11, 2018

Record last verified: 2012-06

Locations

US(2)