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CompletedNCT04225182Updated Mar 24, 2026

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

An interventional study of traditional rehabilitation protocol and with instrumented Orthosis in Gonarthrosis, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gonarthrosis
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In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's enrollment of 65 is close to the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    with instrumented Orthosis

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

    Device: with instrumented Orthosis

  • Active comparator
    without instrumented Orthosis

    patient will follow 8 weeks of traditional muscular strengthening without orthosis

    Device: traditional rehabilitation protocol

Interventions

  • Devicetraditional rehabilitation protocol

    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

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What researchers measure

Primary outcomes

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

    Assessment of knee external knee moment abduction

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

07

Study locations

1 site
  • CHU de Nice
    Nice, 06000, France
08

References and documents

Publications

  • Reneaud N, Zory R, Guerin O, Thomas L, Colson SS, Gerus P, Chorin F. Validation of 3D Knee Kinematics during Gait on Treadmill with an Instrumented Knee Brace. Sensors (Basel). 2023 Feb 6;23(4):1812. doi: 10.3390/s23041812. PubMed 36850411 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04225182
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Jan 13, 2020
Start date
Jan 22, 2020
Primary completion
Jun 2, 2022
Completion
Jun 2, 2022
Last update
Mar 24, 2026

Study contacts

Olivier GUERIN, MD
principal investigator · Nice University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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