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

Not Applicable

Completed

• Conditions: Gonarthrosis
• Interventions: Device: traditional rehabilitation protocol; Device: with instrumented Orthosis

• Registration Number: NCT04225182
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Study Start: 2020-01-22
• Primary Completion: 2022-06-02
• Study Completion: 2022-06-02
• Status Verified: 2022-08
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
without instrumented Orthosis	traditional rehabilitation protocol	patient will follow 8 weeks of traditional muscular strengthening without orthosis
with instrumented Orthosis	with instrumented Orthosis	patient will follow 8 weeks of muscular strengthening with the orthosis connected to the phone app associated

Primary Outcome Measures

Name	Time	Method
Change External Knee Moment Abduction (EKAM) during gait cycle from baseline at 8 weeks after rehabilitation	At the baseline (inclusion) and after 8 weeks of muscular strengthening	Assessment of knee external knee moment abduction

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France