- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01225432
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)
October 20, 2010 updated by: Brooke Army Medical Center
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Fort Sam Houston, Texas, United States, 78234
- Center for the Intrepid
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gait Training
|
12 sessions, 30 minutes of walking on a treadmill with real time therapist directed feedback on gait kinematics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Gait Oxygen Consumption
Time Frame: 3 weeks
|
3 weeks
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Gait Oxygen Consumption
Time Frame: Immediately prior to start of 3 week training.
|
Immediately prior to start of 3 week training.
|
Gait Oxygen Consumption
Time Frame: Immediately post training
|
Immediately post training
|
Gait Oxygen Consumption
Time Frame: 3 weeks later from first post training testing
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3 weeks later from first post training testing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jason M Wilken, PT, PhD, Director, Military Performance Lab-Center for the Intrepid
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Anticipated)
September 1, 2011
Study Registration Dates
First Submitted
October 19, 2010
First Submitted That Met QC Criteria
October 20, 2010
First Posted (Estimate)
October 21, 2010
Study Record Updates
Last Update Posted (Estimate)
October 21, 2010
Last Update Submitted That Met QC Criteria
October 20, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- C.2008.050dt
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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