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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04225182
Enrollment
65
Registered
2020-01-13
Start date
2020-01-22
Completion date
2022-06-02
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gonarthrosis

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.

Interventions

muscular strengthening protocol with traditional rehabilitation protocol without orthosis

DEVICEwith instrumented Orthosis

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

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change External Knee Moment Abduction (EKAM) during gait cycle from baseline at 8 weeks after rehabilitationAt the baseline (inclusion) and after 8 weeks of muscular strengtheningAssessment of knee external knee moment abduction

Countries

France

Contacts

PRINCIPAL_INVESTIGATOROlivier GUERIN, MD

Nice University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026