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

NCT ID: NCT04225182

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-22

Study Completion Date

2022-06-02

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.

Conditions

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Gonarthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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with instrumented Orthosis

patient will follow 8 weeks of muscular strengthening with the orthosis connected to the phone app associated

Group Type EXPERIMENTAL

with instrumented Orthosis

Intervention Type DEVICE

8 weeks of muscular strengthening with the orthosis connected to the phone app associated

without instrumented Orthosis

patient will follow 8 weeks of traditional muscular strengthening without orthosis

Group Type ACTIVE_COMPARATOR

traditional rehabilitation protocol

Intervention Type DEVICE

muscular strengthening protocol with traditional rehabilitation protocol without orthosis

Interventions

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traditional rehabilitation protocol

muscular strengthening protocol with traditional rehabilitation protocol without orthosis

Intervention Type DEVICE

with instrumented Orthosis

8 weeks of muscular strengthening with the orthosis connected to the phone app associated

Intervention Type DEVICE

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier GUERIN, MD

Role: PRINCIPAL_INVESTIGATOR

Nice University Hospital

Locations

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CHU de Nice

Nice, , France

Site Status

Countries

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France

Other Identifiers

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19-PP-19

Identifier Type: -

Identifier Source: org_study_id

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