Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT05581602
Status:
RECRUITING
Last Update Posted:
2024-01-26
First Post:
2022-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Actimetry Monitoring of the Paretic Upper Limb in Chronic Post Stroke.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The first phase of this project is a bicentric cross-sectional study in 30 hemiparetic post-stroke subjects in chronic phase and 30 healthy subjects, age and gender matched.\n\nThe second phase is a 6-month longitudinal study, in a subgroup of 5 post-stroke subjects.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-25', 'studyFirstSubmitDate': '2022-10-11', 'studyFirstSubmitQcDate': '2022-10-11', 'lastUpdatePostDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FuncUseRatio', 'timeFrame': '7 days', 'description': 'The paretic functional use score is a ratio of functional movements performed by the paretic upper limb to the sum of functional movements performed by the paretic and non-paretic upper limbs (in percentage %).'}], 'secondaryOutcomes': [{'measure': 'Use', 'timeFrame': '7 days', 'description': 'Measurement of the amount of functional movement of each upper limb, in an ecological situation during activities of daily living of post-stroke and healthy subjects.'}, {'measure': 'Intensity', 'timeFrame': '7 days', 'description': 'Measurement of the intensity of movements (functional and non-functional) of each upper limb, in an ecological situation during activities of daily living of post-stroke and healthy subjects.'}, {'measure': 'Profil', 'timeFrame': 'During intervention', 'description': 'The activity log is presented in the form of a table. The columns represent the days of recording (Day 1 =\\> Day 7), the rows represent the time slots hour by hour'}, {'measure': 'Motor deficit', 'timeFrame': 'During the inclusion visit or information taken in the medical file', 'description': 'Motor deficit will be measured by the Fugl-Meyer Upper Extremity (FM-UE)'}, {'measure': 'Dispersion of UseRatio', 'timeFrame': '6 months', 'description': 'The dispersion of UseRatio (UseRatioDisp) over the 6 repeated measurements will be measured by the intra-patient interquartile range'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Accelerometry', 'Stroke', 'Upper limb', 'Functional recovery', 'Home environment', 'Rehabilitation', 'Real use', 'Non use'], 'conditions': ['Chronic Stroke', 'Non-use of the Paretic Upper Limb']}, 'descriptionModule': {'briefSummary': "After a stroke, 80% of patients continue to have difficulty using their paretic upper limb in activities of daily living (ADL) despite post-stroke rehabilitation practices that aim to promote the use of the paretic upper limb. It is known that functional recovery depends on actual use (Use it or Loose it), but one-time measurements in the clinic do not allow quantification of the actual use of the paretic upper limb in daily life (in the person's living environment).\n\nThe investigators hypothesize the feasibility of quantifying functional use of the paretic upper limb by actimetry in clinical routine.", 'detailedDescription': "After a stroke, 80% of patients continue to have difficulty using their paretic upper limb in activities of daily living (ADL) despite post-stroke rehabilitation practices that aim to promote the use of the paretic upper limb. It is known that functional recovery depends on actual use (Use it or Loose it), but one-time measurements in the clinic do not allow quantification of the actual use of the paretic upper limb in daily life (in the person's living environment).\n\nProject will monitor 30 chronic and 30 healthy subjects over one week period using two wrist worn sensors .\n\nThe main objective is to objectively quantify by actimetry, over 7 days, the real functional use of the paretic upper limb in the activities of daily living of post-stroke hemiparetic subjects in chronic phase, by the functional use ratio between the two arms (UseRatio)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria common to all participants:\n\n* Be between 18 and 90 years old\n\nPost-stroke subjects should:\n\n* Having a stroke with motor sequelae in the upper limb\n* Be in the chronic phase (\\>3 months post-stroke) of a stroke whatever the aetiology\n\nExclusion Criteria:\n\nNon inclusion criteria common to all participants:\n\n* Absence of free, informed and express oral consent\n* No affiliation to a French social security system or beneficiary of such a system\n* Patient protected by law\n* Pregnant or breastfeeding women\n\nNot eligible for inclusion, post-stroke subjects:\n\n* Not understanding the constraints of the study\n* Have cognitive impairments that prevent them from understanding the study\n* With a known hemigligence in the medical record (omission \\> 8 on bells test)'}, 'identificationModule': {'nctId': 'NCT05581602', 'acronym': 'ParUse', 'briefTitle': 'Actimetry Monitoring of the Paretic Upper Limb in Chronic Post Stroke.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Actimeric Monitoring of the Use of the Paretic Upper Limb in the Activities of Daily Living of the Post-chronic Stroke Subject in a Home Environment', 'orgStudyIdInfo': {'id': 'RECHMPL21_0512'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hemiparetic post-stroke subjects', 'description': 'Stroke patients with motor sequelae in the upper limb.', 'interventionNames': ['Device: Wearing bracelets (3-Axis Logging Accelerometer)']}, {'type': 'OTHER', 'label': 'Healthy subjects', 'description': 'Subjects without stroke.', 'interventionNames': ['Device: Wearing bracelets (3-Axis Logging Accelerometer)']}], 'interventions': [{'name': 'Wearing bracelets (3-Axis Logging Accelerometer)', 'type': 'DEVICE', 'description': 'Participants will be required to wear wristbands containing an accelerometer on each wrist. The bracelets will be kept on both wrists for 7 days with permission to remove them from time to time.', 'armGroupLabels': ['Healthy subjects', 'Hemiparetic post-stroke subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Karima BAKHTI, PhD', 'role': 'CONTACT', 'email': 'k-bakhti@chu-montpellier.fr', 'phone': '0467336111', 'phoneExt': '+33'}], 'facility': 'University Hospital of Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '30900', 'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jerome FROGER', 'role': 'CONTACT'}], 'facility': 'Jerome FROGER', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'centralContacts': [{'name': 'Karima BAKHTI, PhD', 'role': 'CONTACT', 'email': 'k-bakhti@chu-montpellier.fr', 'phone': '0467336111', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université Montpellier', 'class': 'OTHER'}, {'name': 'IMT Mines Alès', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}