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The Effect of Gait Training Using Virtual Reality and Real-Time Feedback on Physiological and Functional Gait Performance in Persons With a Traumatic Lower Extremity Amputation (VRVO2)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Brooke Army Medical Center.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01225432
First Posted: October 21, 2010
Last Update Posted: October 21, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Brooke Army Medical Center
  Purpose
To assess the carryover effect of an innovative new gait training program on physiological and functional gait performance in persons with a traumatic lower extremity amputation. A second objective is to clarify the relationship between gait biomechanics (joint and sgment kinematics and energy cost.

Condition Intervention
Elevated Metabolic Cost Other: Gait Training

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Gait Training Using Virtual Reality and Real-Time Feedback on Physiological and Functional Gait Performance in Persons With a Traumatic Lower Extremity Amputation

Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:
  • Gait Oxygen Consumption [ Time Frame: 3 weeks ]
  • Gait Oxygen Consumption [ Time Frame: Immediately prior to start of 3 week training. ]
  • Gait Oxygen Consumption [ Time Frame: Immediately post training ]
  • Gait Oxygen Consumption [ Time Frame: 3 weeks later from first post training testing ]

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 a treadmill with real time therapist directed feedback on gait kinematics.

  Eligibility

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
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
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): NCT01225432


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

Responsible Party: Jason M. Wilken PT, PhD, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT01225432     History of Changes
Other Study ID Numbers: C.2008.050dt
First Submitted: October 19, 2010
First Posted: October 21, 2010
Last Update Posted: October 21, 2010
Last Verified: October 2010