Gait Modification and Knee Joint Load

Not Applicable

Suspended

• Conditions: Knee Osteoarthritis
• Interventions: Other: Gait modification

• Registration Number: NCT04946136
• Lead Sponsor: Northwestern University

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).

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 Timeline

• Study Start: 2021-01-11
• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-06-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gait modification	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.

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States