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Gait Retraining to Reduce Knee Osteoarthritis Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pete Bradley Shull, Stanford University
ClinicalTrials.gov Identifier:
NCT01397981
First received: July 18, 2011
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to determine how well people can be trained to produce new and different movements through the use of haptic feedback. One particular application is retraining individuals to walk differently in order to reduce knee joint loads to prevent or treat knee osteoarthritis as an alternative to surgical treatments.


Condition Intervention Phase
Osteoarthritis, Knee
Behavioral: Gait retraining
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Haptic Technologies for Movement Retraining

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Measure: Knee pain and function [ Time Frame: four weeks ] [ Designated as safety issue: No ]
    Knee pain and function will be assessed through the standardized KOOS survey


Secondary Outcome Measures:
  • Learning retention, knee adduction moment [ Time Frame: four weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 25
Study Start Date: July 2011
Study Completion Date: November 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Walking modification
Changing kinematics for walking
Behavioral: Gait retraining
Changing the kinematics of walking

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397981

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Study Director: Pete B Shull Stanford University
  More Information