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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)

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ClinicalTrials.gov Identifier: NCT01225432
Recruitment Status : Unknown
Verified October 2010 by Brooke Army Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : October 21, 2010
Last Update Posted : October 21, 2010
Sponsor:
Information provided by:
Brooke Army Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Elevated Metabolic Cost Other: Gait Training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
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
Study Start Date : August 2007
Estimated Primary Completion Date : September 2011

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




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


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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.

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

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 Posted: October 21, 2010    Key Record Dates
Last Update Posted: October 21, 2010
Last Verified: October 2010