Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-03-02 @ 6:22 PM
Study NCT ID:
NCT02882334
Status:
TERMINATED
Last Update Posted:
2021-07-19
First Post:
2016-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Finger Individuation Training With a Training Device Versus Conventional Rehabilitation for Writer's Cramp
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020821', 'term': 'Dystonic Disorders'}], 'ancestors': [{'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': "Difficultés d'inclure, les patients sont rares", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-16', 'studyFirstSubmitDate': '2016-08-24', 'studyFirstSubmitQcDate': '2016-08-26', 'lastUpdatePostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in writing speed after rehabilitation', 'timeFrame': 'Change from baseline writing speed at week 8', 'description': 'number of letters correctly copied in 60 seconds'}]}, 'conditionsModule': {'keywords': ['Focal Dystonia', "Writer's cramp"], 'conditions': ['Dystonic Disorders']}, 'descriptionModule': {'briefSummary': "Writer's cramp (WC) is a focal dystonia characterized by abnormal movements and postures during writing. Limited finger independence during writing manifests as difficulty suppressing unwanted activations of neighbouring non task-relevant fingers. WC patients also have difficulty in fine control of grip force. However, some previous studies indicate positive effects of individual finger movement training in WC although these studies lacked enhanced visual feedback of activations in 'stationary' fingers. The investigators have recently developed the Finger Force Manipulandum which quantifies the forces applied by the fingers in different tasks. This method is sensitive for detection and quantification of small unwanted contractions in non-active ('stationary') fingers. Forces in 'stationary' fingers can be displayed on-line providing enhanced feedback on independence of finger movements. The aim of this study is to test the effectiveness of finger individuation training using the FFM to improve symptoms in WC patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* writer's cramp (diagnostic confirmed by a neurologist specialized in movement disorders\n* handwriting speed \\< 140 letters per minute\n* simple or complex writer's cramp\n* scholarship in French language\n* absence of treatment by botulinum neurotoxin, or last injection \\> 3 months\n* age \\> 18 and \\< 71 years\n* informed consent\n* medical insurance coverage\n\nExclusion Criteria:\n\n* writer's cramp with no impact on writing\n* writing tremor\n* other neurological disease with effect on writing\n* pain or traumatism of the limb used for writing, requiring medical or surgical treatment in the last preceding months\n* participation in another research with a potential impact on evaluation criteria\n* pregnant or breast feeding patient\n* patient under judiciary protection"}, 'identificationModule': {'nctId': 'NCT02882334', 'acronym': 'FIDEX', 'briefTitle': "Finger Individuation Training With a Training Device Versus Conventional Rehabilitation for Writer's Cramp", 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': "Effectiveness Study of Finger Individuation Training by Finger Force Manipulandum (FFM) Compared to Conventional Rehabilitation for Patients With Writer's Cramp", 'orgStudyIdInfo': {'id': 'SSA_2016_15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Finger individuation training', 'description': 'Finger Force Manipulandum', 'interventionNames': ['Device: Finger Force Manipulandum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'conventional physiotherapy', 'interventionNames': ['Other: Conventional physiotherapy']}], 'interventions': [{'name': 'Finger Force Manipulandum', 'type': 'DEVICE', 'armGroupLabels': ['Finger individuation training']}, {'name': 'Conventional physiotherapy', 'type': 'OTHER', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Fondation Ophtalmologique A. de Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jean-Pierre BLETON, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fondation OPH A de Rothschild'}, {'name': 'Pavel Lindberg, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre de Psychiatrie et Neurosciences, Inserm U894'}, {'name': 'Sophie SANGLA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation OPH A de Rothschild'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Foundation Jacques and Gloria Gossweiler', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}