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

July 18, 2011
March 5, 2013
July 2011
April 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01397981 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Gait Retraining to Reduce Knee Osteoarthritis Pain
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis, Knee
Behavioral: Gait retraining
Changing the kinematics of walking
Experimental: Walking modification
Changing kinematics for walking
Intervention: Behavioral: Gait retraining

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
November 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01397981
SU-07142011-8086
Yes
Pete Bradley Shull, Stanford University
Stanford University
Not Provided
Study Director: Pete B Shull Stanford University
Stanford University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP