Gait Retraining to Reduce Knee Osteoarthritis Pain

Osteoarthritis, Knee Clinical Trial

Official title:

Evaluation of Haptic Technologies for Movement Retraining

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01397981
• Other study ID #: SU-07142011-8086
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 18, 2011
• Last updated: March 5, 2013
• Start date: July 2011
• Est. completion date: November 2012

Study information

• Verified date: March 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Gait retraining
Changing the kinematics of walking

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: Knee pain and function	Knee pain and function will be assessed through the standardized KOOS survey	four weeks	No
Secondary	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	four weeks	No