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OpenTrials
Completed

NCT Number: NCT04225182

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

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, 06000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

traditional rehabilitation protocol

Device

muscular strengthening protocol with traditional rehabilitation protocol without orthosis

with instrumented Orthosis

Device

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

Primary outcomes

  1. Change External Knee Moment Abduction (EKAM) during gait cycle from baseline at 8 weeks after rehabilitation

    Time frame: At the baseline (inclusion) and after 8 weeks of muscular strengthening

    Assessment of knee external knee moment abduction

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 13, 2020
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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