Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT03465358
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2018-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of Completion of Items 18, 19 and 22 of the Motor Function Measure (MFM) on a Digital Tablet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2018-03-08', 'studyFirstSubmitQcDate': '2018-03-08', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison scoring between items completed using conventional material or on a digital tablet.', 'timeFrame': '1 day', 'description': 'The comparison of scores between usual test (paper) versus digital tablet test, for the item 18, 19 and 22 of the Motor Function Measure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuromuscular Diseases']}, 'descriptionModule': {'briefSummary': "Motor Function Measure (MFM) is a validated tool assessing the motor function of neuromuscular patients constituted of 32 items. Despite standardized Motor Function Measure (MFM) training sessions, there is still an inter-individual variability in the items' scoring procedure, depending for example on the subjectivity of the therapist.\n\nAmong the 32 items of the MFM, 3 currently require the use of a paper, and could be automated by using a digital tablet. It is the item 18 where the patient traces the edge of a Compact Disc, item 19 requiring to draw loops inside a frame and item 22 requiring to place a finger on each standardized cases. The reproducibility of these 3 items could be improved with the use of a digital tablet and the development of a software allowing to computerize the scoring procedure. The second interest is to implement directly the MFM data in the MFM base.\n\nThe hypothesis is that the difference of scoring of these 3 items between digital tablet versus paper completion is enough low to use indifferently each completion in patients with a neuromuscular disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with neuromuscular disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a labelled neuromuscular disease\n* Patients with Motor Function Measure in one of the participating services during their usual follow-up\n* Patients who received the information and did not object to participating in the study or their parents for the children\n\nExclusion Criteria:\n\n* Patients passing their Motor Function Measure as part of another research protocol'}, 'identificationModule': {'nctId': 'NCT03465358', 'acronym': 'MFM-tablet', 'briefTitle': 'Validation of Completion of Items 18, 19 and 22 of the Motor Function Measure (MFM) on a Digital Tablet', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Validation of Completion of Items 18, 19 and 22 of the Motor Function Measure (MFM) on a Digital Tablet', 'orgStudyIdInfo': {'id': '69HCL17_0851'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Items completion', 'type': 'OTHER', 'description': 'Patients will complete his Motor Function Measure in the usual way, except items 18, 19 and 22 which will be completed twice: once using conventional material and once on a digital tablet.\n\nThe order of completion between conventional material or digital tablet will be allocate randomly.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': "Service de Rééducation Fonctionnelle Pédiatrique - L'Escale (Aile A1) - Hôpital Femme Mère Enfant - GHE", 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Centre de référence MNM Adulte Grenoble Consultation Maladies Neuromusculaires Adultes - CHU Michallon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '69317', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre de référence MNM adulte Lyon Hôpital de la Croix Rousse Bâtiment P', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Service de Médecine Physique et de Réadaptation Pédiatrique Hôpital de Bellevue, CHU', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Centre de référence MNM Adulte Saint Etienne CHU Hôpital Nord-service neurologie', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}