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Recruiting NCT06208631

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

No phase Interventional Osteoarthritis, Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gait retraining.
Who it may be relevant to
Registry conditions: Osteoarthritis, Knee. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Haptic Movement Retraining on Osteoarthritis Progression

Overview

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.

Interventions

  • Behavioral Gait retraining
    Changing muscle coordination while walking

Primary outcome measures

  • Change from baseline in knee contact force [Time frame: Evaluated during the 30 minutes of feedback walking in the second in-lab session and out-of-lab session]
Secondary outcome measures (3)
  • Change from baseline in gastrocnemius activation [Time frame: 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 [Time frame: 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 [Time frame: Evaluated during the 30 minutes of feedback walking in the second in-lab session and the out-of-lab session]

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 of 1-4 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Stanford Human Performance Lab — Stanford

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. PMID 35798755
  • 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. PMID 24615885

Identifiers

NCT: NCT06208631 · 34928

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗