NCT01397981

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

9 months

First QC Date

July 18, 2011

Last Update Submit

March 5, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measure: Knee pain and function

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

    four weeks

Secondary Outcomes (1)

  • Learning retention, knee adduction moment

    four weeks

Study Arms (1)

Walking modification

EXPERIMENTAL

Changing kinematics for walking

Behavioral: Gait retraining

Interventions

Gait retrainingBEHAVIORAL

Changing the kinematics of walking

Walking modification

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related 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.

    PMID: 21459384BACKGROUND
  • 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.

    PMID: 21428681BACKGROUND
  • 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.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Pete B Shull

    Stanford University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 20, 2011

Study Start

July 1, 2011

Primary Completion

April 1, 2012

Study Completion

November 1, 2012

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations