- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06936267
Benefits of Early Proprioceptive Re-education Without Visual Information After Total Knee Arthroplasty (RAPPEL)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: déborah lebedieff
- Phone Number: 0232888265
- Email: deborah.lebedieff@chu-rouen.fr
Study Contact Backup
- Name: Timothée GILLOT, PhD, MKDE
- Phone Number: 02 32 88 06 71
- Email: timothee.gillot@chu-rouen.fr
Study Locations
-
-
-
Bois-Guillaume, France, 76 230
- CRMPR - les herbiers
-
Principal Investigator:
- Manon DANIEULOU
-
Rouen, France, 76 031
- CHU Rouen
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Principal Investigator:
- Eric Verin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: proprioceptive exercise with eyes open
|
proprioceptive exercise with eyes open
|
|
Experimental: proprioceptive exercise with eyes closed
|
proprioceptive exercise with eyes closed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
3 weeks after randomization
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Timothée GILLOT, UH Rouen
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/072/HP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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