Unilateral Primary Osteoarthritis, Left KneeRAPPELNCT06936267
Benefits of Early Proprioceptive Re-education Without Visual Information After Total Knee Arthroplasty
A study testing rehabilitation : eyes closed and rehabilitation : eyes open in people with Unilateral Primary Osteoarthritis, Left Knee, run by University Hospital, Rouen at 2 sites in France.
Trial summary
Osteoarthritis is a common and disabling joint disease, affecting 4.7% of men and 6.6% of women in France. It causes pain and impaired joint mobility, as well as a reduction in proprioception due to damage to intra-articular mechanoreceptors. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Unilateral Primary Osteoarthritis, Left Knee
- What is being tested?
- rehabilitation : eyes closed and rehabilitation : eyes open
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged between 60 and 85 having undergone primary total knee arthroplasty for gonarthrosis
- Patient admitted to a Continuing Care and Rehabilitation (CCR) department and having received a maximum of 1 functional re-education session
- Patient able to remain in bipodal support with eyes closed for 30 seconds on inclusion
- Weight below the limit accepted by the posturography platform (100 kg)
- Patient having read and understood the information letter and having signed the consent form
- Affiliation with the social security system
Who cannot join
- Blindness
- Diabetes with peripheral neuropathy
- Central or peripheral nerve pathology (cerebellar syndrome, stroke sequelae, etc.)
- Previously known ataxia
- Alcoholism not withdrawn
- Pre-existing gait disorders making assessment impossible
Show all 10Show fewer
- Disorders of the vestibular system
- Inflammatory rheumatism
- Length of stay in surgery > 7 days
- Person deprived of liberty by administrative or judicial decision or person placed under court protection / sub-guardianship or guardianship
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
CRMPR - les herbiers
Bois-Guillaume, 76 230
Manon DANIEULOU
Chu Rouen
Rouen, 76 031
Eric Verin
About this study
Osteoarthritis is a common and disabling joint disease, affecting 4.7% of men and 6.6% of women in France. It causes pain and impaired joint mobility, as well as a reduction in proprioception due to damage to intra-articular mechanoreceptors. In the long term, gonarthrosis can lead to limitations in activities of daily living and increase the risk of falls and institutionalisation.
Total knee arthroplasty is an effective treatment for reducing pain and improving functional capacity. However, 50% of patients operated on are not satisfied with the results obtained at 6 months, and between 37% and 55% experience no significant improvement in their functional mobility. It is therefore important to better define the modalities of rehabilitation interventions in order to improve their efficiency and the functional benefits for the patient.
Proprioception, the visual system and the vestibular system are the three major systems involved in posture and balance. Rehabilitation interventions aimed at improving balance involve these three inputs and their interaction. Studies have shown that proprioceptive rehabilitation can significantly improve balance and gait in patients who have undergone total knee arthroplasty. However, visual feedback may hinder the development of balance skills by limiting the use of other sensorimotor systems.
Read the detailed description
The aim of this research project is to determine the benefits of visual deprivation and the methods of early proprioceptive exercises, right from the start of rehabilitation, on postural control in patients following total knee arthroplasty. Proprioceptive re-education with the eyes closed will be used from the very first rehabilitation sessions, evaluating its effect on proprioception. Currently, only one study has looked at the influence of the visual system in proprioceptive rehabilitation after total knee arthroplasty, seeking to assess the superiority of exercises with visual feedback compared with exercises without such feedback. The investigator presents an opposite and innovative questioning by proposing to evaluate on a larger scale the influence of visual deprivation rather than visual feedback.
- Being tested
- rehabilitation : eyes closed, rehabilitation : eyes open
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation : eyes closedOther
proprioceptive exercise with eyes closed
rehabilitation : eyes openOther
proprioceptive exercise with eyes open
| Study group | Role | What they receive |
|---|---|---|
| proprioceptive exercise with eyes open | Active comparator | * 30 minutes of techniques to increase joint amplitude
* 15 to 30 minutes of muscular strengthening of the hamstrings against resistance (elastic or pulley), of the quadriceps without resistance and then against a light weight (1 to 2 kg).
* 15 to 30 minutes of proprioceptive exercises, eyes open.
* 10 to 15 minutes of functional exercises: walking, overcoming obstacles, going up and down stairs
* 20 minutes of pressure therapy Receives: Other: rehabilitation : eyes open |
| proprioceptive exercise with eyes closed | Experimental | * 30 minutes of techniques to increase joint amplitude
* 15 to 30 minutes of muscular strengthening of the hamstrings against resistance (elastic or pulley), of the quadriceps without resistance and then against a light weight (1 to 2 kg).
* 15 to 30 minutes of proprioceptive exercises, eyes closed
* 10 to 15 minutes of functional exercises: walking, overcoming obstacles, going up and down stairs
* 20 minutes of pressure therapy Receives: Other: rehabilitation : eyes closed |
What is being measured
The primary outcome is the main question the study is designed to answer.
the length of the projection of the centre of gravity on a posturography platform, in bipedal support, eyes closed, over 30 seconds
The main evaluation criterion is the length of the trace of the projection of the centre of gravity on a posturography platform, in bipedal support, eyes closed, over 30 seconds at 3 weeks (± 5 days) post-operatively or at discharge from the rehabilitation department, at the first intervening element.
For this protocol, the posturographic analysis will be performed in the gait analysis laboratory of the Rouen Normandy University Hospital (Neurophysiology Department), by an investigator blinded to the treatment arm and trained in the use of the software.
Measured: 3 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study startMar 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Primary Osteoarthritis, Left KneeStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothée GILLOT, Principal investigator, UH ROUEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936267
- Sponsor's protocol ID
- 2019/072/HP
- Acronym
- RAPPEL
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Early Proprioceptive Re-education Without Visual Information After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06936267
- Acronym / sponsor ID
- RAPPEL / 2019/072/HP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 20 Apr 2025 (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.
Osteoarthritis is a common and disabling joint disease, affecting 4.7% of men and 6.6% of women in France. It causes pain and impaired joint mobility, as well as a reduction in proprioception due to damage to intra-articular mechanoreceptors. In the long term, gonarthrosis can lead to limitations in activities of daily living and increase the risk of falls and institutionalisation.
Total knee arthroplasty is an effective treatment for reducing pain and improving functional capacity. However, 50% of patients operated on are not satisfied with the results obtained at 6 months, and between 37% and 55% experience no significant improvement in their functional mobility. It is therefore important to better define the modalities of rehabilitation interventions in order to improve their efficiency and the functional benefits for the patient.
Proprioception, the visual system and the vestibular system are the three major systems involved in posture and balance. Rehabilitation interventions aimed at improving balance involve these three inputs and their interaction. Studies have shown that proprioceptive rehabilitation can significantly improve balance and gait in patients who have undergone total knee arthroplasty. However, visual feedback may hinder the development of balance skills by limiting the use of other sensorimotor systems.
Detailed description
The aim of this research project is to determine the benefits of visual deprivation and the methods of early proprioceptive exercises, right from the start of rehabilitation, on postural control in patients following total knee arthroplasty. Proprioceptive re-education with the eyes closed will be used from the very first rehabilitation sessions, evaluating its effect on proprioception. Currently, only one study has looked at the influence of the visual system in proprioceptive rehabilitation after total knee arthroplasty, seeking to assess the superiority of exercises with visual feedback compared with exercises without such feedback. The investigator presents an opposite and innovative questioning by proposing to evaluate on a larger scale the influence of visual deprivation rather than visual feedback.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| proprioceptive exercise with eyes open | Active comparator | Other: rehabilitation : eyes open* 30 minutes of techniques to increase joint amplitude * 15 to 30 minutes of muscular strengthening of the hamstrings against resistance (elastic or pulley), of the quadriceps without resistance and then against a light weight (1 to 2 kg). * 15 to 30 minutes of proprioceptive exercises, eyes open. * 10 to 15 minutes of functional exercises: walking, overcoming obstacles, going up and down stairs * 20 minutes of pressure therapy |
| proprioceptive exercise with eyes closed | Experimental | Other: rehabilitation : eyes closed* 30 minutes of techniques to increase joint amplitude * 15 to 30 minutes of muscular strengthening of the hamstrings against resistance (elastic or pulley), of the quadriceps without resistance and then against a light weight (1 to 2 kg). * 15 to 30 minutes of proprioceptive exercises, eyes closed * 10 to 15 minutes of functional exercises: walking, overcoming obstacles, going up and down stairs * 20 minutes of pressure therapy |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient aged between 60 and 85 having undergone primary total knee arthroplasty for gonarthrosis
- Patient admitted to a Continuing Care and Rehabilitation (CCR) department and having received a maximum of 1 functional re-education session
- Patient able to remain in bipodal support with eyes closed for 30 seconds on inclusion
- Weight below the limit accepted by the posturography platform (100 kg)
- Patient having read and understood the information letter and having signed the consent form
Key exclusion criteria (10 listed)
- Blindness
- Diabetes with peripheral neuropathy
- Central or peripheral nerve pathology (cerebellar syndrome, stroke sequelae, etc.)
- Previously known ataxia
- Alcoholism not withdrawn
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 |
|---|---|---|
| rehabilitation : eyes closedproprioceptive exercise with eyes closed | Other | proprioceptive exercise with eyes closed |
| rehabilitation : eyes openproprioceptive exercise with eyes open | Other | proprioceptive exercise with eyes open |
Primary outcome
the length of the projection of the centre of gravity on a posturography platform, in bipedal support, eyes closed, over 30 seconds
Time frame: 3 weeks after randomization
The main evaluation criterion is the length of the trace of the projection of the centre of gravity on a posturography platform, in bipedal support, eyes closed, over 30 seconds at 3 weeks (± 5 days) post-operatively or at discharge from the rehabilitation department, at the first intervening element. For this protocol, the posturographic analysis will be performed in the gait analysis laboratory of the Rouen Normandy University Hospital (Neurophysiology Department), by an investigator blinded to the treatment arm and trained in the use of the software.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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.
Timothée GILLOT principal investigator
UH ROUEN
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitation : eyes closed and rehabilitation : eyes open in people with Unilateral Primary Osteoarthritis, Left Knee, run by University Hospital, Rouen at 2 sites 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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothée GILLOT, PhD, MKDE (02 32 88 06 71, timothee.gillot@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the length of the projection of the centre of gravity on a posturography platform, in bipedal support, eyes closed, over 30 seconds (time frame: 3 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2026.