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Amputee Gait Training Using Virtual Reality and Real-Time Feedback (VRGAIT)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT01225120
First received: October 19, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

The purpose of this repeated measures design gait training study is to develop and quantitatively assess the effectiveness of a virtual reality training environment using real-time feedback for modification of pelvic motion during gait.


Condition Intervention
Abnormal Gait Kinematics
 Other: Gait Training

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Amputee Gait Training Using Virtual Reality and Real-Time Feedback

Resource links provided by NLM:

MedlinePlus related topics: Limb Loss
U.S. FDA Resources

Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:
  • Gait Biomechanics [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Gait Biomechanics [ Time Frame: immediately prior to start of 3 week training ] [ Designated as safety issue: No ]
  • Gait Biomechanics [ Time Frame: Immediately post training ] [ Designated as safety issue: No ]
  • Gait Biomechanics [ Time Frame: 3 weeks from initial post training ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: August 2007
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gait Training Other: Gait Training
12 sessions, 30 minutes of walking on treadmill with real time therapist directed feedback on gait kinematics.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Unilateral traumatic trans-tibial or transfemoral amputation
  • Independent ambulation without an assistive device for a minimum of three months
  • Ability to ambulate continuously for a minimum of 15 minutes
  • Trans-femoral participants must use an ischial containment socket
  • VAS Pain scores on the involved side of less than 4/10
  • Sagittal plane ankle, knee and hip strength of 4 or greater on the uninvolved side as determined by manual muscle test.

Exclusion Criteria:

  • Blindness
  • TBI-Glascow Coma Scale score of 12 or lower at the time of injury
  • Cardiac or pulmonary problems limiting physical activity
  • PTSD or other psychological condition with symptoms that would be exacerbated by participation in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225120

Locations
United States, Texas
Center for the Intrepid
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
Brooke Army Medical Center
Investigators
Principal Investigator: Jason M Wilken, PT, PhD Director, Military Performance Lab-Center for the Intrepid
  More Information

No publications provided

Responsible Party: Jason M. Wilken PT, PhD, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT01225120     History of Changes
Other Study ID Numbers: C.2007.072t
Study First Received: October 19, 2010
Last Updated: October 19, 2010
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on May 19, 2013