Gait Retraining to Reduce Knee Osteoarthritis Pain

March 5, 2013 updated by: Pete Bradley Shull, Stanford University

Evaluation of Haptic Technologies for Movement Retraining

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2
  • Phase 1

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

    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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: 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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Pete B Shull, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

July 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

July 18, 2011

First Submitted That Met QC Criteria

July 19, 2011

First Posted (Estimate)

July 20, 2011

Study Record Updates

Last Update Posted (Estimate)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 5, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

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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