Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-27 @ 10:53 PM
Study NCT ID:
NCT05915533
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2023-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of the Implementation of Dance Therapy Workshops on the Quality of Life of Adults With Disabilities Institutionalized Within the Medico-social Establishments of the Univi Group
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003614', 'term': 'Dance Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-09-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2023-06-13', 'studyFirstSubmitQcDate': '2023-06-13', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WHOQOL-BREF scale', 'timeFrame': 'Eight months', 'description': 'The WHOQOL-BREF has 26 questions and measures 4 domains: physical health, mental health, social relations and the environment.THE ANALYSIS IS DONE on the scores generated for each of the domains.the WHOQOL-BREF is generally recognized as a reliable and valid instrument for estimating quality of life'}], 'secondaryOutcomes': [{'measure': 'Tinetti test: assessement of walking and balance', 'timeFrame': 'Eight months', 'description': 'Tinetti test is an effective and reproductible tool for the assessement of the risk of falling, its administration time is approximately 5 to 10 minutes and evaluates static and dynamic balance'}, {'measure': 'Get up and Go test', 'timeFrame': 'Eight months', 'description': 'This test evaluates the transfers sitting, standing, walking and changes of direction'}, {'measure': 'Time up and Go test', 'timeFrame': 'Eight months', 'description': 'The time up and go test is the timed version of the get up and go test. The subject seated on a chair must get up, walk 3 meters in front of him, return to his chair and sit down. The score is given by the time in seconds.\n\nInterpretation: risk of falling if the score is greater than or equal to 21 seconds.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dance Therapy Workshop']}, 'descriptionModule': {'briefSummary': 'Dance is a multimodal activity involving motor, cognitive, sensory and sensory-motor skills as well as emotional and social skills. A growing body of research shows that the creative arts and physical exercise are able to alleviate disability, improve social interactions.\n\nThe Associative Group UNIVI wants to evaluate through this study the effects of the practice of dance on the quality of life of the disabled adults accomodates in social medical establishments of UNIVI group', 'detailedDescription': 'this research is an interventional study involving the human person of category 2 involving only minimal risks and constraints, it is multicentric and longitudinal prospective. This is a before/after study to measure the effects of the implementation of a dance therapy activity on the quality of life of the adults with disabilities housed in the 5 establishments of the univi group.\n\nThe dance therapy will be deployed in all the medico-social establishments participating in the study over a period of 12 weeks.\n\nTo do this, dance therapists will be recruited to provide these classes.\n\nThe dance-therapy will be carried out:\n\n* in groups of 10 to 12 people who have given their informed consent,\n* at least twice a week per group,\n* over a period of 30 to 45 minutes maximum twice a week for 3 months. Several groups per establishment can be planned depending on the number of people who can and want to be included in the dance workshop.\n\n 940 participant in the study will be inclued and followed at 1 month, 3 months and 6 months after the end of the dance therapy workshops.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with disabilities residing in medico-social establishments, including participant under guardianship or curatorship\n* informed consent to participate in the study\n* Participant with a minimum of language skills to understand instructions and simple questions\n\nExclusion Criteria:\n\n* Contraindication to the practice of dance\n* Adults with disabilities temporarily housed\n* Severe cognitive and/or behavioral disorders that do not allow you to follow a dance workshop\n* Permanent bed rest\n* Non-affiliation to a social security scheme'}, 'identificationModule': {'nctId': 'NCT05915533', 'acronym': 'danceworkshops', 'briefTitle': 'Impact of the Implementation of Dance Therapy Workshops on the Quality of Life of Adults With Disabilities Institutionalized Within the Medico-social Establishments of the Univi Group', 'organization': {'class': 'OTHER', 'fullName': 'Centre Médical Porte Verte'}, 'officialTitle': 'Impact of the Implementation of Dance Therapy Workshops on the Quality of Life of Adults With Disabilities Institutionalized Within the Medico-social Establishments of the Univi Group: Longitudinal Intervention Study', 'orgStudyIdInfo': {'id': '2023-A01119-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Before/after study', 'interventionNames': ['Other: Dance therapy']}], 'interventions': [{'name': 'Dance therapy', 'type': 'OTHER', 'description': 'Before/after study to measure the effects of the dance therapy activity on the quality of life of the disabled adults housed in the establishments of UNIVI group.', 'armGroupLabels': ['Before/after study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78004', 'city': 'Versailles', 'country': 'France', 'facility': 'Hopital La Porte Verte', 'geoPoint': {'lat': 48.80359, 'lon': 2.13424}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Médical Porte Verte', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}