- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01397981
Gait Retraining to Reduce Knee Osteoarthritis Pain
Evaluation of Haptic Technologies for Movement Retraining
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
During the movement retraining session, you be given different combinations of haptic, visual, and auditory feedback in order to inform you on desired movement changes. This will take place at the Human Performance Laboratory at Stanford University. Motion analysis will be done while you perform movement activities (such as locomotion).
Prior to performing these movement tasks the investigators will attach reflective markers to your body using tape, pre-wrap and/or ace bandages. The investigators will record motion of your body's movements using infrared cameras which capture anatomical data from the reflective markers on your body.
The investigators will provide you with feedback to inform you of desired movement modifications. Haptic feedback devices such as vibration motors and skin stretch devices will be attached to your body via velcro straps and will be used to give "touch" feedback. There will be a computer monitor in front of you during testing to provide visual feedback. Sounds will be played using speakers near the testing area to provide auditory feedback.
The time needed for set up and performance of the above set of tests is approximately 90 minutes. You will be performing walking and other movements for only a small part of that time. The rest of the time will be spent preparing you for the experiment. After the investigators examine your movement data, if some of the data appear inaccurate or the investigators are unable to process the data, the investigators may ask you to repeat the movement analysis at a later time.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Symptoms of medial compartment pain during the previous 6 weeks
- Radiographic evidence (AP X-ray) of medial compartment knee osteoarthritis (KL score of 3 or less)
- Ability to walk unaided for 25 minutes without rest
- Age > 18
Exclusion Criteria:
- BMI > 30
- Previous injury or surgery on foot, ankle, knee, hip, or back inhibiting ability to adopt different walking gait
- Use of shoe insert or hinged knee brace
- Corticosteroid injection within the previous 6 weeks
- Age > 80
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Walking modification
Changing kinematics for walking
|
Changing the kinematics of walking
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure: Knee pain and function
Time Frame: four weeks
|
Knee pain and function will be assessed through the standardized KOOS survey
|
four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Learning retention, knee adduction moment
Time Frame: four weeks
|
Learning retention of gait kinematics and knee joint loading including the knee adduction moment will be measured through motion capture and ground reaction force plates
|
four weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pete B Shull, Stanford University
Publications and helpful links
General Publications
- Shull PB, Lurie KL, Cutkosky MR, Besier TF. Training multi-parameter gaits to reduce the knee adduction moment with data-driven models and haptic feedback. J Biomech. 2011 May 17;44(8):1605-9. doi: 10.1016/j.jbiomech.2011.03.016. Epub 2011 Apr 2.
- Wheeler JW, Shull PB, Besier TF. Real-time knee adduction moment feedback for gait retraining through visual and tactile displays. J Biomech Eng. 2011 Apr;133(4):041007. doi: 10.1115/1.4003621.
- Shull PB, Shultz R, Silder A, Dragoo JL, Besier TF, Cutkosky MR, Delp SL. Toe-in gait reduces the first peak knee adduction moment in patients with medial compartment knee osteoarthritis. J Biomech. 2013 Jan 4;46(1):122-8. doi: 10.1016/j.jbiomech.2012.10.019. Epub 2012 Nov 10.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-07142011-8086
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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