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NCT04225182 Clinical Trial

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

Gonarthrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04225182
Other study ID # 19-PP-19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 22, 2020
Est. completion date June 2, 2022

Study information
Verified date August 2022
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date June 2, 2022
Est. primary completion date June 2, 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• traditional rehabilitation protocol
muscular strengthening protocol with traditional rehabilitation protocol without orthosis
• with instrumented Orthosis
8 weeks of muscular strengthening with the orthosis connected to the phone app associated

Locations
Country Name City State
France CHU de Nice Nice

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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