Clinical trial NCT06208631: Effects of Movement Retraining on Knee Loading in Individuals With Knee Osteoarthritis
Official title: Effects of Haptic Movement Retraining on Osteoarthritis Progression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in knee contact force
timeFrame: Evaluated during the second session of up to 30 minutes of gait retraining
Secondary outcomes:
measure: Change from baseline in gastrocnemius activation
timeFrame: Evaluated during first session of up to 30 minutes of gait retraining and the second session of up to 30 minutes of gait retraining
measure: Proportion of participants that reduce gastrocnemius activation
timeFrame: Evaluated during first session of up to 30 minutes of gait retraining and the second session of up to 30 minutes of gait retraining
measure: Proportion of participants that reduce knee contact force
timeFrame: Evaluated during the second session of up to 30 minutes of gait retraining
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Human Performance Lab
state: California
Study officials:
affiliation: Stanford University
name: Scott L Delp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.