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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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 23, 2014