NCT06208631

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress80%
Jan 2024Dec 2026

First Submitted

Initial submission to the registry

December 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

January 18, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 9, 2025

Status Verified

October 1, 2025

Enrollment Period

2.9 years

First QC Date

December 18, 2023

Last Update Submit

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

EXPERIMENTAL

Participants will learn to change muscle coordination while walking through real-time haptic biofeedback based on the activation of the gastrocnemius muscle

Behavioral: Gait retraining

Interventions

Gait retrainingBEHAVIORAL

Changing muscle coordination while walking

Gait modification

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

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: 9262899BACKGROUND
  • Kather 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

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Scott L Delp, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

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

De-identified experimental data and simulation results will be made available.

Time Frame
After publication and no end date
Access Criteria
Data will be publicly available online at SimTK.

Locations