GonarthrosisNCT04225182
Evaluation of the Effectiveness of a Muscular Strengthening Protocol With an Instrumented Orthosis for Gonarthrosis Patients
A study testing traditional rehabilitation protocol and with instrumented Orthosis in people with Gonarthrosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Gonarthrosis
- What is being tested?
- traditional rehabilitation protocol and with instrumented Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2020to 2 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Person who signed informative consent
- Affiliated with the social security
- Male and female aged between 50 and 80
- Walk without assistance
- Smartphone's use
Who cannot join
- 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
Show all 9Show fewer
- Symptomatic hip OA
- Knee infection
- Knee injuries
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Gonarthrosis
- Being tested
- traditional rehabilitation protocol, with instrumented Orthosis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional rehabilitation protocolDevice
muscular strengthening protocol with traditional rehabilitation protocol without orthosis
with instrumented OrthosisDevice
8 weeks of muscular strengthening with the orthosis connected to the phone app associated
| Study group | Role | What they receive |
|---|---|---|
| with instrumented Orthosis | Experimental | patient will follow 8 weeks of muscular strengthening with the orthosis connected to the phone app associated Receives: Device: with instrumented Orthosis |
| without instrumented Orthosis | Active comparator | patient will follow 8 weeks of traditional muscular strengthening without orthosis Receives: Device: traditional rehabilitation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change External Knee Moment Abduction (EKAM) during gait cycle from baseline at 8 weeks after rehabilitation
Assessment of knee external knee moment abduction
Measured: At the baseline (inclusion) and after 8 weeks of muscular strengthening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start22 Jan 2020
- Primary completion2 Jun 2022
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GonarthrosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier GUERIN, MD, Principal investigator, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225182
- Sponsor's protocol ID
- 19-PP-19
- Status last verified
- Mar 2026
- First submitted
- 7 Jan 2020
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Muscular Strengthening Protocol With an Instrumented Orthosis for Gonarthrosis Patients
- ClinicalTrials.gov ID
- NCT04225182
- Acronym / sponsor ID
- 19-PP-19
- Conditions
- Gonarthrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with instrumented Orthosis | Experimental | Device: with instrumented Orthosispatient will follow 8 weeks of muscular strengthening with the orthosis connected to the phone app associated |
| without instrumented Orthosis | Active comparator | Device: traditional rehabilitation protocolpatient will follow 8 weeks of traditional muscular strengthening without orthosis |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Person who signed informative consent
- Affiliated with the social security
- Male and female aged between 50 and 80
- Walk without assistance
- Smartphone's use
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traditional rehabilitation protocolmuscular strengthening protocol with traditional rehabilitation protocol without orthosis | Device | without instrumented Orthosis |
| with instrumented Orthosis8 weeks of muscular strengthening with the orthosis connected to the phone app associated | Device | with instrumented Orthosis |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 36850411Reneaud 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier GUERIN, MD principal investigator
Nice University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional rehabilitation protocol and with instrumented Orthosis in people with Gonarthrosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04225182, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.