Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-01-05 @ 6:03 PM
Study NCT ID:
NCT03149458
Status:
UNKNOWN
Last Update Posted:
2019-07-15
First Post:
2017-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dance Workshop on Balance of Hemiparetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010291', 'term': 'Paresis'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-12', 'studyFirstSubmitDate': '2017-02-27', 'studyFirstSubmitQcDate': '2017-05-09', 'lastUpdatePostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed up and Go', 'timeFrame': '5min', 'description': 'get up, walk 3m, turn around and return sit down'}], 'secondaryOutcomes': [{'measure': 'Berg Balance Scale', 'timeFrame': '10min', 'description': 'clinical scale assessing balance. 14-item scale designed to measure balance of the older adult in a clinical setting. Scoring: A five-point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 56'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'balance', 'dance'], 'conditions': ['Hemiparesis']}, 'descriptionModule': {'briefSummary': "The majority of hemiparetic patients have balance disorders, which impact independence in daily living activities and walking. Conventional techniques used in rehabilitation improve balance but have shown no effects on dynamic balance required during walking. Recently dance is proposed to improve dynamic balance in older people and people with Parkinson's disease. Although many studies showed that dance is an effective activity to improve balance in these people, it has never been assessed in hemiparetic patients (except a case report). The aim of this study is to show that a dance program improves the balance of hemiparetic patients, compared to a control group. This randomized controlled study aims to include 40 hemiparetic patients who will perform a dance program (experimental group) or a upper-limb rehabilitation program (control group) for 8 one-hour sessions.", 'detailedDescription': 'Randomized controlled study aims to include 40 hemiparetic patients who will perform a dance program (experimental group) or a upper-limb rehabilitation program (control group) for 8 one-hour sessions. These activities are carried out in the form of a workshop and are already proposed in common practice in the service. They are carried out by the physiotherapists of the service. Patients are assigned in one of two study groups. It is specified that they will be able to carry out the program of the opposing group at the end of the study in order to limit the "disappointment" effect. The evaluations will be carried out at 4 and 8 weeks and will mainly rely on data of balance, function, quality of life and satisfaction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who signed the consent letter\n* Male or female adults age ≥ 18 years,\n* Hemiparetic patient\n* Patient with balance disorders, able to walk alone and perform a U-turn, with or without technical assistance.\n\nExclusion Criteria:\n\n* Bilateral brain lesions, cerebellar syndrome\n* Other pathology or impairment that may interfere with the study such as visual, cardiovascular or other uncontrolled medical conditions\n* Patient who underwent surgery of the musculoskeletal system in The 6 months prior to inclusion\n* Major cognitive disorders not allowing the dance activity or the passing of evaluations\n* Behavioral disorders not allowing group workshops\n* Pregnant woman, breastfeeding\n* Non-affiliation to a social security scheme (beneficiary or beneficiary)'}, 'identificationModule': {'nctId': 'NCT03149458', 'acronym': 'DanceStudio', 'briefTitle': 'Dance Workshop on Balance of Hemiparetic Patients', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Investigation Clinique et Technologique 805"}, 'officialTitle': 'Effects of a Dance Workshop on the Balance Abilities of Hemiparetic Patients', 'orgStudyIdInfo': {'id': '2016-A01876-45'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dance group', 'description': 'dance program for 8 one-hour sessions.', 'interventionNames': ['Other: dance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'upper limb rehabilitation for 8 one-hour sessions.', 'interventionNames': ['Other: control']}], 'interventions': [{'name': 'dance', 'type': 'OTHER', 'description': 'dance program', 'armGroupLabels': ['Dance group']}, {'name': 'control', 'type': 'OTHER', 'description': 'upper limb rehabilitation', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Céline Bonnyaud, PhD', 'role': 'CONTACT', 'email': 'celine.bonnyaud@aphp.fr', 'phone': '0033147107068'}, {'name': 'Alexandra Delarue, PT', 'role': 'CONTACT', 'email': 'alexandra.delarue@gmail.com', 'phone': '0033147107068'}], 'facility': 'Raymond Poincaré Hospital- PMR Unit - Netter', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'centralContacts': [{'name': 'François GENET, PhD', 'role': 'CONTACT', 'email': 'francois.genet@aphp.fr', 'phone': '+33 (1) 47 10 70 68'}, {'name': 'Fatima IZEDAREN', 'role': 'CONTACT', 'email': 'fatima.izedaren@aphp.fr', 'phone': '+33 (1)47 10 44 49'}], 'overallOfficials': [{'name': 'François GENET, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre d'Investigation Clinique et Technologique 805"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre d'Investigation Clinique et Technologique 805", 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation Garches', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}