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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06208631
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Stanford University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Scott L Delp, PhD
Principal Investigator Affiliation Stanford University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Knee
Arms & Interventions

Arms

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

Interventions

Behavioral: - Gait retraining

Changing muscle coordination while walking

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford Human Performance Lab, Stanford, California

Status

Recruiting

Address

Stanford Human Performance Lab

Stanford, California, 94305

Site Contact

Scott D Uhlrich, PhD

[email protected]

650-721-2547