Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT04888702
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-12
First Post:
2021-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Holter of Movement in Patients with SMA Undergoing Treatment.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009134', 'term': 'Muscular Atrophy, Spinal'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'all patients undergo clinical evaluation and wear Actimyo device in daily living to evaluate their improvement under treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2021-03-11', 'studyFirstSubmitQcDate': '2021-05-11', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '95th centile of stride velocity', 'timeFrame': '39 months', 'description': '95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life.\n\n(meter per second).'}, {'measure': '50th centile of stride velocity', 'timeFrame': '39 months', 'description': '50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).'}, {'measure': '95th centile of stride length', 'timeFrame': '39 months', 'description': '95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).'}, {'measure': '50th centile of stride length', 'timeFrame': '39 months', 'description': '50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).'}, {'measure': 'Upper limb function evolution in patient with SMA undergoing treatment', 'timeFrame': '39 months', 'description': 'Upper limb function assessed with a magneto-inertial sensor (Actimyo°) in real-life.'}], 'secondaryOutcomes': [{'measure': '6-minute walk test', 'timeFrame': '39 months', 'description': 'The Six-Minute Walk Test is a functional walking test in which investigators assess the distance the patient can walk in six minutes (meter).'}, {'measure': 'Dynamometric measures', 'timeFrame': '39 months', 'description': 'Assessment of upper limb strength with myogrip and myopinch (kg).'}, {'measure': '10-metre walk test', 'timeFrame': '39 months', 'description': 'The 10-metre walk test is a functional walking test in which investigators assess the time the patient take to walk 10 meters (second).'}, {'measure': 'rise from floor', 'timeFrame': '39 months', 'description': 'The rise from floor is a functional test in which investigators assess the time the patient take to rise from the floor (second).'}, {'measure': '4-stair climb', 'timeFrame': '39 months', 'description': 'The 4-stair climbr is a functional test in which investigators assess the time the patient take to climb a four-step staircase (second).'}, {'measure': 'revised upper limb module (RULM)', 'timeFrame': '39 months', 'description': 'Revised Upper Limb Module (RULM) is an assessment specifically designed for upper limb function in Spinal Muscular Atrophy.'}, {'measure': 'Hamersmith funcitonnal motor scale (HFMS)', 'timeFrame': '39 months', 'description': 'HFMS is a scale is specifically designed outcome measure for people affected by Spinal Muscular Atrophy.'}, {'measure': 'motor function measure (MFM)', 'timeFrame': '39 months', 'description': 'Motor Function Measure is a global quantitative scale created to measure the functional motor abilities of a person affected by a neuromuscular disease.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Actimyo', 'Accelerometry', 'Motor neuron disease', 'Risdiplam', 'Nusinersen', 'Home monitoring'], 'conditions': ['Spinal Muscular Atrophy']}, 'descriptionModule': {'briefSummary': 'Acti-SMA is a multi-centric academic study. It aims to monitor the progress of patients with spinal muscular atrophy under treatment with Spinraza° or risdiplam. First, we want to quantify improvement of both ambulant and non-ambulant patients under treatment. A secondary objective would also be to identify suitable accelerometric measurements that are sensitive to change but also well correlated to other clinical scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Genetically confirmed spinal muscular atrophy.\n* Treatment by Spinraza ° or by risdiplam planned.\n* Over 6 years old.\n* Signed informed consent.\n\nExclusion Criteria:\n\n\\- Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.'}, 'identificationModule': {'nctId': 'NCT04888702', 'briefTitle': 'Holter of Movement in Patients with SMA Undergoing Treatment.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Liege'}, 'officialTitle': 'Holter of Movement in Patients with Type 2 or 3 Spinal Muscular Atrophy When Initiating Treatment with Spinraza ° or Risdiplam. Acti-SMA Study.', 'orgStudyIdInfo': {'id': 'ActiSMA.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SMA patients', 'description': 'Patients with type 2 or 3 spinal muscular atrophy undergoing Spinraza° or risdiplam treatment.', 'interventionNames': ['Device: Actimyo']}], 'interventions': [{'name': 'Actimyo', 'type': 'DEVICE', 'description': 'Actimyo° is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.', 'armGroupLabels': ['SMA patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'state': 'Liège', 'country': 'Belgium', 'facility': 'Centre Hospitalier Régional de la Citadelle', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Erasme Hospital - Cliniques universitaires de Bruxelles', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'National Clinical Hospital for Children Neurohabilitation "Dr Nicolae Robanescu"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], 'overallOfficials': [{'name': 'Margaux Poleur', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Citadelle-CHU liège'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Liege', 'class': 'OTHER'}, 'collaborators': [{'name': 'SYSNAV', 'class': 'INDUSTRY'}, {'name': 'Erasme University Hospital', 'class': 'OTHER'}, {'name': "Queen Fabiola Children's University Hospital", 'class': 'OTHER'}, {'name': 'Centre Hospitalier Régional de la Citadelle', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Margaux POLEUR', 'investigatorAffiliation': 'Centre Hospitalier Universitaire de Liege'}}}}