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

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ClinicalTrials.gov Identifier: NCT01225120
Recruitment Status : Unknown
Verified October 2010 by Brooke Army Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : October 20, 2010
Last Update Posted : October 20, 2010
Information provided by:
Brooke Army Medical Center

Brief Summary:
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 or disease Intervention/treatment
Abnormal Gait Kinematics Other: Gait Training

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Amputee Gait Training Using Virtual Reality and Real-Time Feedback
Study Start Date : August 2007
Estimated Primary Completion Date : September 2011

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Gait Training Other: Gait Training
12 sessions, 30 minutes of walking on treadmill with real time therapist directed feedback on gait kinematics.

Primary Outcome Measures :
  1. Gait Biomechanics [ Time Frame: 3 weeks ]
  2. Gait Biomechanics [ Time Frame: immediately prior to start of 3 week training ]
  3. Gait Biomechanics [ Time Frame: Immediately post training ]
  4. Gait Biomechanics [ Time Frame: 3 weeks from initial post training ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225120

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

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
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: October 20, 2010
Last Verified: October 2010