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

Osteoarthritis, Knee Clinical Trial

Official title:

Effects of Haptic Movement Retraining on Osteoarthritis Progression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06208631
• Other study ID #: 34928
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Study Team
• Phone: 650-721-2547
• Email: oawalking[@]lists.stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Gait retraining
Changing muscle coordination while walking

Locations

Country	Name	City	State
United States	Stanford Human Performance Lab	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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