Gait Modification Treatments for Knee Pathology

Study Overview
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Brief Summary
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The objective of this study is complete a longitudinal cross-over clinical study to investigate the effect of treatments for knee pathology, including cutaneous stimulation (skin vibration and soft knee brace), on locomotion tasks (i.e. walking, jogging, stair ascending and descending), muscle function, and pain/function.

Official Title
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Analysis of Pain, Function, and Joint Mechanics in Response to Two Treatments for Knee Pathology

Conditions
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Knee Injuries, Knee Osteoarthritis

Intervention / Treatment
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* Device: Cutaneous Stimulation
* Device: Knee Sleeve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 Ambulatory Symptomatic knee pain ≥ 3/10 on most of the past 30 days Prior ACL injury/surgery, meniscus injury/surgery, and/or physician-diagnosed medial compartment knee osteoarthritis (KL grade 1-3) Agreement and ability to use provided interventions during the study period (suggested cumulative wear time during walking of 1-2 hr/day) Committed to not starting any new therapies for knee condition during the trial, other than rescue pain medication. Exclusion Criteria: Use of walking aid (e.g. cane, crutch, walker, or wheelchair) BMI ≥ 35 kg/m2 Injection in the affected knee during the previous three months Known neuropathy due to diabetes or other causes Inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Treatment A then B<br>Subjects will receive two treatments: (1) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback (vibration) to the subject and (2) a commercially-available knee sleeve, separated by a washout period. | Device: Cutaneous Stimulation<br>* A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.<br>Device: Knee Sleeve<br>* Commercially-available knee sleeve.<br>|
| Experimental: Experimental Treatment B then A<br>Subjects will receive two treatments: (1) a commercially-available knee sleeve and (2) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback (vibration) to the subject, separated by a washout period. | Device: Cutaneous Stimulation<br>* A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.<br>Device: Knee Sleeve<br>* Commercially-available knee sleeve.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Peak Knee Flexion Moment (%Bw*Ht) | Within-subject change (follow-up - baseline) in peak knee flexion moment (%Bodyweight*Height) with the intervention at 4-week follow-up versus control (without the intervention) at baseline. | Baseline and 4 week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain | Within-subject change (follow-up - baseline) in pain (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Baseline and 4 week follow-up | 
| Change in Function | Within-subject change (follow-up - baseline) in function (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Baseline and 4 week follow-up | 
| Change in Symptoms | Within-subject change (follow-up - baseline) in symptoms (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Baseline and 4-week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee pathology