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Behavioural Intervention

Movement Retraining for Osteoarthritis

N/A

Recruiting

Led By Scott L Delp, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Kellgran-Lawrence grade I, II, or III

Diagnosed with knee osteoarthritis of at least six months duration

Must not have

Replacement of any lower extremity joint

Symptoms originating from the patellofemoral joint

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluated during first session of up to 30 minutes of gait retraining and the second session of up to 30 minutes of gait retraining

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand if individuals with knee osteoarthritis can learn to change their calf muscle activation while walking. Previous studies have shown that reducing calf muscle activation can help reduce knee loading. Participants

Who is the study for?

This trial is for individuals with knee osteoarthritis who are capable of walking and interested in learning a new way to walk that might reduce stress on their knees. Participants should be able to attend up to three training sessions.

What is being tested?

The study tests if people with knee osteoarthritis can learn to use less calf muscle (specifically the gastrocnemius) while walking, using haptic feedback. It checks whether this new walking strategy reduces the load on their knees.

What are the potential side effects?

Since this intervention involves gait retraining rather than medication, side effects may include muscle fatigue or discomfort due to the change in walking pattern.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My joint wear is mild to moderate.

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I have had knee arthritis for at least 6 months.

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I can walk without any help or devices.

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I can walk for at least 60 minutes without stopping.

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My usual pain level is 4 or less on a scale of 0 to 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a hip or knee replacement.

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My knee pain comes from the kneecap area.

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I have a nerve or muscle disease that makes it hard for me to walk.

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I have had a surgery or a fracture in my leg that needed a hospital stay.

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My knee frequently collapses or gives way.

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I have a history of rheumatoid arthritis, gout, or an autoimmune disease.

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My knee is severely misaligned, more than 5 degrees off from straight.

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I have had painful arthritis in my lower limbs, not including my knees.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evaluated during first session of up to 30 minutes of gait retraining and the second session of up to 30 minutes of gait retraining

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~evaluated during first session of up to 30 minutes of gait retraining and the second session of up to 30 minutes of gait retraining

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated during first session of up to 30 minutes of gait retraining and the second session of up to 30 minutes of gait retraining for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in knee contact force

Secondary study objectives

Change from baseline in gastrocnemius activation

Proportion of participants that reduce gastrocnemius activation

Proportion of participants that reduce knee contact force

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Gait modificationExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gait retraining

2011

Completed Phase 2

~150

0 / 13Eligibility criteria met