Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT06936267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-20
First Post:
2025-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Benefits of Early Proprioceptive Re-education Without Visual Information After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2025-04-04', 'studyFirstSubmitQcDate': '2025-04-11', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the length of the projection of the centre of gravity on a posturography platform, in bipedal support, eyes closed, over 30 seconds', 'timeFrame': '3 weeks after randomization', 'description': '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.\n\nFor 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unilateral Primary Osteoarthritis, Left Knee']}, 'descriptionModule': {'briefSummary': '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.\n\nTotal 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.\n\nProprioception, 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged between 60 and 85 having undergone primary total knee arthroplasty for gonarthrosis\n* Patient admitted to a Continuing Care and Rehabilitation (CCR) department and having received a maximum of 1 functional re-education session\n* Patient able to remain in bipodal support with eyes closed for 30 seconds on inclusion\n* Weight below the limit accepted by the posturography platform (100 kg)\n* Patient having read and understood the information letter and having signed the consent form\n* Affiliation with the social security system\n\nExclusion Criteria:\n\n* Blindness\n* Diabetes with peripheral neuropathy\n* Central or peripheral nerve pathology (cerebellar syndrome, stroke sequelae, etc.)\n* Previously known ataxia\n* Alcoholism not withdrawn\n* Pre-existing gait disorders making assessment impossible\n* Disorders of the vestibular system\n* Inflammatory rheumatism\n* Length of stay in surgery \\> 7 days\n* Person deprived of liberty by administrative or judicial decision or person placed under court protection / sub-guardianship or guardianship'}, 'identificationModule': {'nctId': 'NCT06936267', 'acronym': 'RAPPEL', 'briefTitle': 'Benefits of Early Proprioceptive Re-education Without Visual Information After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Benefits of Early Proprioceptive Re-education Without Visual Information After Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '2019/072/HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'proprioceptive exercise with eyes open', 'description': '* 30 minutes of techniques to increase joint amplitude\n* 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).\n* 15 to 30 minutes of proprioceptive exercises, eyes open.\n* 10 to 15 minutes of functional exercises: walking, overcoming obstacles, going up and down stairs\n* 20 minutes of pressure therapy', 'interventionNames': ['Other: rehabilitation : eyes open']}, {'type': 'EXPERIMENTAL', 'label': 'proprioceptive exercise with eyes closed', 'description': '* 30 minutes of techniques to increase joint amplitude\n* 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).\n* 15 to 30 minutes of proprioceptive exercises, eyes closed\n* 10 to 15 minutes of functional exercises: walking, overcoming obstacles, going up and down stairs\n* 20 minutes of pressure therapy', 'interventionNames': ['Other: rehabilitation : eyes closed']}], 'interventions': [{'name': 'rehabilitation : eyes closed', 'type': 'OTHER', 'description': 'proprioceptive exercise with eyes closed', 'armGroupLabels': ['proprioceptive exercise with eyes closed']}, {'name': 'rehabilitation : eyes open', 'type': 'OTHER', 'description': 'proprioceptive exercise with eyes open', 'armGroupLabels': ['proprioceptive exercise with eyes open']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76 230', 'city': 'Bois-Guillaume', 'country': 'France', 'contacts': [{'name': 'Manon DANIEULOU', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CRMPR - les herbiers', 'geoPoint': {'lat': 49.4602, 'lon': 1.12219}}, {'zip': '76 031', 'city': 'Rouen', 'country': 'France', 'contacts': [{'name': 'Eric Verin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chu Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'Timothée GILLOT, PhD, MKDE', 'role': 'CONTACT', 'email': 'timothee.gillot@chu-rouen.fr', 'phone': '02 32 88 06 71'}, {'name': 'déborah lebedieff', 'role': 'CONTACT', 'email': 'deborah.lebedieff@chu-rouen.fr', 'phone': '0232888265'}], 'overallOfficials': [{'name': 'Timothée GILLOT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH ROUEN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}