Effects of Movement Retraining on Knee Loading in Individuals With Knee Osteoarthritis

Effects of Haptic Movement Retraining on Osteoarthritis Progression

This study investigates how well individuals with knee osteoarthritis can learn to alter their calf muscle activation using haptic biofeedback while walking and evaluates how these changes affect knee loading.

Prior research has utilized musculoskeletal simulations to determine that reducing the activation of one of the calf muscles, the gastrocnemius, can have a large impact on reducing knee loading. However, this has not been tested in individuals with knee osteoarthritis. In this study, participants will be trained to alter the activation of their gastrocnemius muscle, by receiving haptic feedback after each step. The feedback will indicate how the participant changed their muscle activation relative to baseline. Participants will train for up to three sessions, with 30 minutes of walking with feedback in each session. If a participant can learn to adjust their muscle activation in the first training session, they will be able to complete the second training session. An exploratory third session may be conducted to investigate changes in knee loading while using the new walking strategy during over-ground walking.

The movement data collected during the training sessions will be used as inputs to computer simulations of the musculoskeletal system to determine if walking with the new muscle activation strategy reduces knee loading.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Behavioral: Gait retraining

• Study Type: Interventional
• Enrollment (Estimated): 13
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Team; Phone Number: 650-721-2547; Email: oawalking@lists.stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford Human Performance Lab
      • Contact: Scott D Uhlrich, PhD; Phone Number: 650-721-2547; Email: oawalking@lists.stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Medial and/or lateral compartment knee osteoarthritis
• Diagnosed with knee osteoarthritis of at least six months duration
• Ambulatory without aids
• Able to walk for at least 60 minutes
• Typical pain rating less than or equal to 4 on scale of 0-10
• Able to reduce gastrocnemius muscle activation by 10% from baseline

Exclusion Criteria:

• History of symptomatic arthritis in lower limb joints other than the knees
• Replacement of any lower extremity joint
• Symptoms originating from the patellofemoral joint
• Body mass index equal to or greater than 35
• Nerve or muscle disease associated with walking difficulty
• History of rheumatoid arthritis, gout, or autoimmune disease
• History of lower limb fracture or surgery requiring hospitalization
• Pregnant
• Severe knee malalignment, defined as a hip-knee-ankle angle of more than 5 degrees from neutral
• Recurrent giving way of the knee

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gait modification; Participants will learn to change muscle coordination while walking through real-time haptic biofeedback based on the activation of the gastrocnemius muscle	Behavioral: Gait retraining; Changing muscle coordination while walking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in knee contact force	Knee contact force will be evaluated using motion capture data and musculoskeletal modeling and simulations, for participants that are able to reduce gastrocnemius activation.	Evaluated during the second session of up to 30 minutes of gait retraining

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in gastrocnemius activation	Gastrocnemius activation measured through EMG signals.	Evaluated during first session of up to 30 minutes of gait retraining and the second session of up to 30 minutes of gait retraining
Proportion of participants that reduce gastrocnemius activation	Gastrocnemius activation will be measured through electromyography (EMG) signals, and the muscle activation during gait retraining will be compared to baseline walking. Participants that can reduce gastrocnemius activation 10% or more from baseline within 30 minutes of gait retraining will be counted as participants that can reduce gastrocnemius activation out of the total number of participants who try the gait retraining.	Evaluated during first session of up to 30 minutes of gait retraining and the second session of up to 30 minutes of gait retraining
Proportion of participants that reduce knee contact force	For the participants who can successfully reduce gastrocnemius activation from baseline, knee contact force will be calculated using motion capture data and musculoskeletal modeling and simulations. The proportion of participants that reduce knee contact force from baseline during gait retraining out of the total participants that reduce gastrocnemius activation will be evaluated.	Evaluated during the second session of up to 30 minutes of gait retraining

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Scott L Delp, PhD, Stanford University

Publications and helpful links

General Publications

• Uhlrich SD, Jackson RW, Seth A, Kolesar JA, Delp SL. Muscle coordination retraining inspired by musculoskeletal simulations reduces knee contact force. Sci Rep. 2022 Jul 7;12(1):9842. doi: 10.1038/s41598-022-13386-9.
• Demers MS, Pal S, Delp SL. Changes in tibiofemoral forces due to variations in muscle activity during walking. J Orthop Res. 2014 Jun;32(6):769-76. doi: 10.1002/jor.22601. Epub 2014 Feb 26.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: January 6, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 34928

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified experimental data and simulation results will be made available.
• IPD Sharing Time Frame: After publication and no end date
• IPD Sharing Access Criteria: Data will be publicly available online at SimTK.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No