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

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: Gonarthrosis

Treatments: Device: traditional rehabilitation protocol; Device: with instrumented Orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT04225182

19-PP-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

with instrumented Orthosis

Experimental group

Description:

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

Treatment:

Device: with instrumented Orthosis

without instrumented Orthosis

Active Comparator group

Description:

patient will follow 8 weeks of traditional muscular strengthening without orthosis

Treatment:

Device: traditional rehabilitation protocol