Effects of Movement Retraining on Knee Loading in Individuals With Knee Osteoarthritis
Effects of Haptic Movement Retraining on Osteoarthritis Progression
1 other identifier
interventional
31
1 country
1
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. Some participants will train on a treadmill in the laboratory for up to two 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. Other participants will train outside the laboratory for one session with 30 minutes of walking with feedback 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2023
CompletedFirst Posted
Study publicly available on registry
January 17, 2024
CompletedStudy Start
First participant enrolled
January 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
October 9, 2025
October 1, 2025
2.9 years
December 18, 2023
October 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 30 minutes of feedback walking in the second in-lab session and out-of-lab session
Secondary Outcomes (3)
Change from baseline in gastrocnemius activation
Evaluated during the 30 minutes of feedback walking in the first in-lab session, the second in-lab session, and the out-of-lab session
Proportion of participants that reduce gastrocnemius activation
Evaluated during the 30 minutes of feedback walking in the first in-lab session, the second in-lab session, and the out-of-lab session
Proportion of participants that reduce knee contact force
Evaluated during the 30 minutes of feedback walking in the second in-lab session and the out-of-lab session
Study Arms (1)
Gait modification
EXPERIMENTALParticipants will learn to change muscle coordination while walking through real-time haptic biofeedback based on the activation of the gastrocnemius muscle
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford Human Performance Lab
Stanford, California, 94305, United States
Related Publications (2)
Lee KJ, Hahm KB, Kim YS, Kim JH, Cho SW, Jie H, Park CH, Yim H. The usefulness of Tc-99m HMPAO labeled WBC SPECT in eosinophilic gastroenteritis. Clin Nucl Med. 1997 Aug;22(8):536-41. doi: 10.1097/00003072-199708000-00005.
PMID: 9262899BACKGROUNDKather L, Smidt D. [Composition of porcine uterine secretion]. Berl Munch Tierarztl Wochenschr. 1974 Oct 1;87(19):372-4. No abstract available. German.
PMID: 4409006BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott L Delp, PhD
Stanford University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Bioengineering and Mechanical Engineering
Study Record Dates
First Submitted
December 18, 2023
First Posted
January 17, 2024
Study Start
January 18, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
October 9, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- After publication and no end date
- Access Criteria
- Data will be publicly available online at SimTK.
De-identified experimental data and simulation results will be made available.