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Gait Retraining to Reduce Knee Osteoarthritis Pain

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gait retraining
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Walking modification

Arm Description

Changing kinematics for walking

Outcomes

Primary Outcome Measures

Measure: Knee pain and function
Knee pain and function will be assessed through the standardized KOOS survey

Secondary Outcome Measures

Learning retention, knee adduction moment
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

Full Information

First Posted
July 18, 2011
Last Updated
March 5, 2013
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT01397981
Brief Title
Gait Retraining to Reduce Knee Osteoarthritis Pain
Official Title
Evaluation of Haptic Technologies for Movement Retraining
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Walking modification
Arm Type
Experimental
Arm Description
Changing kinematics for walking
Intervention Type
Behavioral
Intervention Name(s)
Gait retraining
Intervention Description
Changing the kinematics of walking
Primary Outcome Measure Information:
Title
Measure: Knee pain and function
Description
Knee pain and function will be assessed through the standardized KOOS survey
Time Frame
four weeks
Secondary Outcome Measure Information:
Title
Learning retention, knee adduction moment
Description
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
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pete B Shull
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21459384
Citation
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.
Results Reference
background
PubMed Identifier
21428681
Citation
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.
Results Reference
background
PubMed Identifier
23146322
Citation
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.
Results Reference
result

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Gait Retraining to Reduce Knee Osteoarthritis Pain

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