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)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT01225432
First received: October 19, 2010
Last updated: October 20, 2010
Last verified: October 2010
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Gait Oxygen Consumption [ Time Frame: Immediately prior to start of 3 week training. ] [ Designated as safety issue: No ]
  • Gait Oxygen Consumption [ Time Frame: Immediately post training ] [ Designated as safety issue: No ]
  • Gait Oxygen Consumption [ Time Frame: 3 weeks later from first post training testing ] [ 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 a 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 19, 2010
Last Updated: October 20, 2010
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on September 18, 2014