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Gait Modification and Knee Joint Load

Sponsor
Northwestern University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04946136
Collaborator
(none)
16
Enrollment
1
Location
1
Arm
18.6
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This pilot study aims to assess the effect of a 6-week individualized gait retraining program on knee load and symptoms in persons with knee osteoarthritis (OA).

Condition or Disease Intervention/Treatment Phase
  • Other: Gait modification
 N/A

Detailed Description

This study aims to pilot-test an individualized gait retraining intervention to reduce knee load, guided by real-time visual feedback of the external knee adduction moment (KAM), a commonly used determinant for medial tibiofemoral (TF) joint load, during walking. Our central hypothesis is that individuals with predominantly medial TF OA can adapt their gait patterns to lower KAM during walking; consequently, reduce knee load and pain.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
This is a pilot single-arm study examining the effect of an intervention on biomechanical and symptomatic outcomes. There is no control group, therefore no masking employed.
Primary Purpose:
Treatment
Official Title:
The Effect of Gait Modification on Knee Joint Load in Persons With Medial Tibiofemoral Osteoarthritis - A Pilot Study
Actual Study Start Date :
Jan 11, 2021
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gait modification

In this pilot study, participants modify their gait patterns guided by real-time visual feedback on their medial knee load while walking on an instrumented treadmill.

Other: Gait modification
Individualized gait modifications guided by real-time visual feedback of knee load

Outcome Measures

Primary Outcome Measures

  1. External knee adduction moment during walking [Baseline-to-6-week change]

    The external knee adduction moment during walking will be assessed using a10-camera optical motion capture system and force plates. A visual 3D program will be used to compute and plot the pre- and post-intervention external knee adduction moment during walking.

  2. WOMAC (Western Ontario and McMaster Universities) score [Baseline-to-6-week change]

    WOMAC questionnaire contains 24 questions in three domains of pain (score range 0-20), stiffness (score range 0-8) and physical function (score range 0-68). Higher score indicates worse symptom/function.

Secondary Outcome Measures

  1. External knee flexion moment during walking [Baseline-to-6-week change]

    The external knee flexion moment during walking will be assessed using a10-camera optical motion capture system and force plates. A visual 3D program will be used to compute and plot the pre- and post-intervention external knee flexion moment during walking.

  2. KOOS (Knee Injury and Osteoarthritis Outcome Score) [Baseline-to-6-week change]

    KOOS questionnaire contains 42 items in 5 domains of pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life. Scores are transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no problems.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • people with radiographic TF OA fulfilling American College of Rheumatology classification criteria

  • reporting average knee pain on walking > 3 on an 11-point scale (0-10) in at least one knee

  • pain or tenderness predominantly located on the medial knee.

Exclusion Criteria:

  • medial TF joint space width greater than lateral

  • Kellgren/Lawrence (K/L) grade 4

  • knee surgery or intra-articular corticosteroid injection in the past 6 months

  • uncomfortable walking on treadmill for 20 minutes

  • unable to walk without a walking aide

  • inflammatory arthritis

  • other musculoskeletal or neurological disorders that affect gait patterns

  • currently receiving physical therapy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern University Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University

Investigators

  • Principal Investigator: Alison H Chang, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alison Chang, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier:
NCT04946136
Other Study ID Numbers:
  • STU00212048
First Posted:
Jun 30, 2021
Last Update Posted:
Jul 1, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee

Study Results

No Results Posted as of Jul 1, 2021