Gait Modification and Knee Joint Load

Knee Osteoarthritis Clinical Trial

Official title:

The Effect of Gait Modification on Knee Joint Load in Persons With Medial Tibiofemoral Osteoarthritis - A Pilot Study

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04946136
• Other study ID #: STU00212048
• Status: Suspended
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 16
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	External knee adduction moment during walking	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.	Baseline-to-6-week change
Primary	WOMAC (Western Ontario and McMaster Universities) score	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.	Baseline-to-6-week change
Secondary	External knee flexion moment during walking	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.	Baseline-to-6-week change
Secondary	KOOS (Knee Injury and Osteoarthritis Outcome Score)	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.	Baseline-to-6-week change