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:
Brooke Army Medical Center
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
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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 |
Resource links provided by NLM:
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
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 June 18, 2013