Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-26 @ 6:24 AM
Study NCT ID:
NCT05006859
Status:
RECRUITING
Last Update Posted:
2025-03-11
First Post:
2021-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wheelchair Positioning and Neuromuscular Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2021-08-11', 'studyFirstSubmitQcDate': '2021-08-11', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of postural wheelchair disorders in the neuromuscular disease population', 'timeFrame': 'At the beginning and the end of the study, an average of 6 months', 'description': 'Measurement of Posture by the tool: Measurement of Postural Control in Seated Postural Control Measure for Adults 2.0 (SPCMA 2.0) score (0 = normal, 1 = mild, 2 = moderated and 3 = severe)'}], 'secondaryOutcomes': [{'measure': 'Comparison of pain associated with using the wheelchair', 'timeFrame': 'At the beginning and the end of the study (before positioning equipment and few months after use), an average of 6 months', 'description': 'Assessment of initial pain (before positioning equipment) and pain after positioning equipment.\n\nPain is assessed by a Simple Verbal Scale or by a Visual Analog Scale (0 to 10) (0 = no pain and 10 is the strongest pain)'}, {'measure': 'Assessment of the incidence of pressure ulcers associated with sitting in NMD', 'timeFrame': 'At the beginning and the end of the study (before positioning equipment and few months after use), an average of 6 months', 'description': 'Observation of the topography and the stage of ulcers associated with sitting'}, {'measure': 'Assessment of the proportion of technical postural aids prescribed for patients who accept the positioning equipment', 'timeFrame': 'At the end of the study, an average of 6 months', 'description': 'Counts of the numbers of technical postural aids prescribed during consultation'}, {'measure': 'Assessment of the technical postural aids efficacy', 'timeFrame': 'At the beginning and the end of the study (before positioning equipment and few months after use), an average of 6 months', 'description': 'Comparison of Postural Control in Seated Postural Control Measure for Adults 2.0 (SPCMA 2.0) score before and after using of technical postural aids (0 = normal, 1 = mild, 2 = moderated and 3 = severe)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuromuscular disease', 'Postural wheelchair disorders', 'Wheelchair positioning', 'Pain'], 'conditions': ['Neuromuscular Diseases']}, 'descriptionModule': {'briefSummary': 'This database will describe sitting postural control in wheelchair, as well as PW pain, and pressure ulcers associated with sitting, in patients with neuromuscular disease (NMD).', 'detailedDescription': 'Neuromuscular diseases are genetic diseases of the muscle or its innervation (nerve connection) causing respiratory, cardiac and especially motor difficulties which may require use of wheelchair. However there is no standardized positioning protocol, so it seems interesting to us to study wheelchair positioning in neuromuscular diseases).\n\nThe purpose of this study is to describe sitting posture in the wheelchair in patients with neuromuscular disease, pain associated with using the wheelchair, but also to assess the effectiveness of the recommended equipment making the same evaluations in follow-up consultation (a few months after receipt of the prescribed TAP).\n\nPosture is assessed by the tool: Measurement of Postural Control in Seated Postural Control Measure for Adults 2.0 (SPCMA 2.0), which is a validated tool.\n\nPain is assessed by a Simple Verbal Scale or by a Visual Analog Scale. This database could allow providing guidelines of good practice, for wheelchair positioning for patients with neuromuscular disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with neuromuscular disease, using Wheelchair, seen in positioning consultation by N. Pellegrini and / or E. Dupitier', 'eligibilityCriteria': "Inclusion Criteria :\n\n* Patient with neuromuscular disease\n* Written informed consent (IC) obtained\n* Adult patients (\\> 18 years) Or\n* Adults under guardianship who has given theirs oral consent and guardian's consent obtained Or\n* Childs who has given theirs oral consent and parents' consent obtained\n* Wheelchair user\n\nExclusion Criteria :\n\n• Patient not seen in positioning consultation by N. Pellegrini and / or E. Dupitierr"}, 'identificationModule': {'nctId': 'NCT05006859', 'acronym': 'BDD-POSIT-MNM', 'briefTitle': 'Wheelchair Positioning and Neuromuscular Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Groupement Hospitalier Intercommunal du Vexin'}, 'officialTitle': 'Wheelchair Positioning and Neuromuscular Diseases Database (Retrospective and Prospective)', 'orgStudyIdInfo': {'id': 'GHIV0321'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cohorte', 'type': 'OTHER', 'otherNames': ['Questionnaire'], 'description': 'Assessment of postural wheelchair disorders, as well as PW pain, and pressure ulcers associated with sitting'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95510', 'city': 'Aincourt', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nadine Pellegrini, Dr', 'role': 'CONTACT', 'email': 'nadine.pellegrini@ght-novo.fr', 'phone': '+33 1 34 79 44 75'}], 'facility': "Groupement Hospitalier Intercommunal du Vexin / Site d'Aincourt - Pôle Soins de Suite et de Réadaptation spécialisés", 'geoPoint': {'lat': 49.07242, 'lon': 1.77303}}, {'zip': '91 000', 'city': 'Évry', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elise Dupitier', 'role': 'CONTACT', 'email': 'edupitier@afm-telethon.fr', 'phone': '+33 1 69 47 28 28'}], 'facility': "Clinique du Positionnement de l'AFM", 'geoPoint': {'lat': 48.6328, 'lon': 2.44049}}], 'centralContacts': [{'name': 'Maryline Delattre', 'role': 'CONTACT', 'email': 'maryline.delattre@ght-novo.fr', 'phone': '+331.30.75.41.31'}, {'name': 'Audrey Gilibert', 'role': 'CONTACT', 'email': 'audrey.gilibert@ght-novo.fr', 'phone': '+331.30.75.40.40', 'phoneExt': '72.57'}], 'overallOfficials': [{'name': 'Nadine Pellegrini', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Groupement Hospitalier Intercommunal du Vexin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupement Hospitalier Intercommunal du Vexin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Association Française contre les Myopathies (AFM), Paris', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}