Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-27 @ 8:15 PM
Study NCT ID:
NCT04882904
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2021-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic 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 evolution.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2021-03-11', 'studyFirstSubmitQcDate': '2021-05-11', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '95th centile of stride velocity', 'timeFrame': '1 year', 'description': '95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).'}, {'measure': '50th centile of stride velocity', 'timeFrame': '1 year', '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': '1 year', 'description': '95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).'}, {'measure': '50th centile of stride length', 'timeFrame': '1 year', 'description': '50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).'}], 'secondaryOutcomes': [{'measure': 'Upper limb function evolution in patient with ALS', 'timeFrame': '1 year', 'description': 'Upper limb function assessed with a magneto-inertial sensor (Actimyo°) in real-life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Actimyo', 'Accelerometry', 'Daily living'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': 'ActiSLA is a monocentric academic study. Patients with amyotrophic lateral sclerosis may be included on a voluntary basis. The investigators plan to include a group of approximately 20 patients with ALS.\n\nThe investigators have planned to assess patient every three months for a year. On each visit, participants will undergo a clinical examination with MRC sum score and Ashworth scores.\n\nThey will perform few tests ( 6-minutes walk test (6MWT), dynamometric measure, electromyography, Edinburgh Cognitive and Behavioural ALS Screen ) and will answer to some questionaires (dysphagia handicap scale, ALS-SFR-r).\n\nAfter each visit, participants will wear Actimyo for one month daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinically defined or probable diagnosis of ALS according to El Escorial criteria revised with Awaji's electro-diagnostic algorithm.\n* Over 18 years old.\n* Signed informed consent\n* If patient on Riluzole, the dosage should be stable for 1 month and continued throughout the study period.\n\nExclusion Criteria:\n\n* Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.\n* Any other previous or present pathology having an impact on motor function.\n* Recent surgery or trauma (less than 6 months) in the upper or lower limbs.\n* Prior neurological, endocrine, infectious, allergic, or chronic or acute inflammatory pathology in the three weeks preceding inclusion.\n* Patients participating in an interventional clinical trial."}, 'identificationModule': {'nctId': 'NCT04882904', 'briefTitle': 'Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Liege'}, 'officialTitle': 'Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects', 'orgStudyIdInfo': {'id': 'ActiLiège. ActiSLA part.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient with ALS', 'description': 'Patient with amyotrophic lateral sclerosis', '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': ['Patient with ALS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'state': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Laurie MEDARD', 'role': 'CONTACT', 'email': 'Laurie.Medard@citadelle.be', 'phone': '43218222', 'phoneExt': '0032'}], 'facility': 'CHR Citadelle', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'centralContacts': [{'name': 'Laurie MEDARD', 'role': 'CONTACT', 'email': 'Laurie.Medard@citadelle.be', 'phone': '43218222', 'phoneExt': '0032'}], 'overallOfficials': [{'name': 'Margaux Poleur, MD', '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': 'Centre Hospitalier Régional de la Citadelle', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinator of reference center for neuromuscular diseases', 'investigatorFullName': 'Laurent Servais', 'investigatorAffiliation': 'Centre Hospitalier Universitaire de Liege'}}}}