Evaluation of the Effectiveness of a Muscular Strengthening Protocol With an Instrumented Orthosis for Gonarthrosis Patients

Study Overview
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Brief Summary
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The management of knee osteoarthritis via a physical activity protocol for rehabilitation has convincing results. However, the effectiveness of these protocols could be improved with a connected instrumented knee brace with an exercise protocol adapted for the patient which is supervise by an online physiotherapist to check the progression during home-based rehabilitation.

Detailed Description
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The management of knee osteoarthritis via physical activity protocol for rehabilitation has convincing results. The aim of this study is to determine the improvement of the effectiveness of a home-based rehabilitation with and without instrumented knee brace for moderated gonarthrosis patients. The study will focus during one years on 80 moderated gonarthrosis patients with a Kellgren and Lawrence (K&L) score between 2 and 3, aged between 50 and 80. Each patient will practice an 8 weeks progressive home exercise program with 3 session per weeks. The effectiveness of this protocol will be quantified with a gait analysis with kinematics, kinetics and electromyography, before and after the progressive home exercise protocol. The statistical analysis will focus on ANOVA and correlation between control group and instrumented knee brace group.

Official Title
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Evaluation of the Effectiveness of a Muscular Strengthening Protocol With an Instrumented Orthosis for Gonarthrosis Patients

Conditions
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Gonarthrosis

Intervention / Treatment
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* Device: traditional rehabilitation protocol
* Device: with instrumented Orthosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Person who signed informative consent Affiliated with the social security Male and female aged between 50 and 80 Walk without assistance Smartphone's use Exclusion criteria: Person under protective measure Orthopedics issues Neurologic issues (MMSE Test < 24) Knee or hip prothesis Person with NSAIDs and analgesics treatment with an effective intake less than 48 hours before the evaluation Predominant patello-femoral arthritis Symptomatic hip OA Knee infection Knee injuries

Ages Eligible for Study
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Minimum Age: 50 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with instrumented Orthosis<br>patient will follow 8 weeks of muscular strengthening with the orthosis connected to the phone app associated | Device: with instrumented Orthosis<br>* 8 weeks of muscular strengthening with the orthosis connected to the phone app associated<br>|
| Active Comparator: without instrumented Orthosis<br>patient will follow 8 weeks of traditional muscular strengthening without orthosis | Device: traditional rehabilitation protocol<br>* muscular strengthening protocol with traditional rehabilitation protocol without orthosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change External Knee Moment Abduction (EKAM) during gait cycle from baseline at 8 weeks after rehabilitation | Assessment of knee external knee moment abduction | At the baseline (inclusion) and after 8 weeks of muscular strengthening |