Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT06239012
Status:
COMPLETED
Last Update Posted:
2025-08-01
First Post:
2024-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reliability and Validity Evaluation of the BePoW Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020886', 'term': 'Somatosensory Disorders'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'exploratory, monocentric, reliability-validity clinical investigation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2024-01-25', 'studyFirstSubmitQcDate': '2024-01-25', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliability assessment: intraclass correlation coefficient (ICC) between BePoW measurements', 'timeFrame': 'Immediately after inclusion', 'description': '12 data records for each measurement for intra ICC'}, {'measure': 'Validity assessment: correlation coefficient r between raw goniometric measurements and BePoW measurements,', 'timeFrame': 'Immediately after inclusion', 'description': 'kappa coefficient between recoded measurements : BePow / MCPAA'}], 'secondaryOutcomes': [{'measure': 'Assess the validity of BePoW measurements in relation to fatigability.', 'timeFrame': 'Immediately after inclusion', 'description': 'assessment using a visual numerical scale, from 0 to 10'}, {'measure': 'Assess the validity of BePoW measurements in relation to autonomy.', 'timeFrame': 'Immediately after inclusion', 'description': 'assessment by the MIF (Measure of Functional Independence) questionnaire from 21 (total dependence) to 47 (completely independent)'}, {'measure': 'Assessing the validity of BePoW measurements in relation to respiratory capacity', 'timeFrame': 'Immediately after inclusion', 'description': 'assessed by the ratio of forced expiratory volume in one second (FEV1) to FEV1 at 6 seconds (FEV 6).\n\nSpirometry will be performed 3 times, with the highest value retained.'}, {'measure': 'Determine the standard error measurement (SEM) on angular measurements taken by BePoW', 'timeFrame': 'Immediately after inclusion', 'description': 'Calculation of the standard error measurement (SEM) of each measurement taken by the device.'}, {'measure': 'Determining the minimum detectable change (MDC) on angular measurements taken by BePoW', 'timeFrame': 'Immediately after inclusion', 'description': 'Calculation of the minimum detectable change (MDC) of each measurement taken by the device.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Position Sense Disorders']}, 'descriptionModule': {'briefSummary': "The aim of this clinical investigation is to develop a reliable and valid device to instantly measure the subject's sitting posture in a wheelchair, without using the MCPAA scale.", 'detailedDescription': 'Each subject will be invited to a single experimental session lasting approximately one hour, during which all assessments will be performed.\n\nDuring the visit, the patient will complete an autonomy questionnaire and assess wheelchair fatigue. A spirometry test will be performed.\n\nThe measurements will then be recorded by the BePoW software and the occupational therapist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Over 18 years of age,\n* Having freely consented to participate in the study (or their legal representative in the case of guardianship, in agreement with the patient),\n* In the case of a guardianship, the legal representative having read the information document intended for the legal guardian of an adult under legal protection (under guardianship) and given his/her free and informed consent for the person for whom he/she is responsible to participate in the study (in agreement with the patient).\n* Temporarily or permanently wheelchair-bound,\n* Affiliated with a social security scheme or beneficiary of such a scheme.\n\nExclusion Criteria:\n\n* Has comprehension problems that prevent him/her from giving free and informed consent and from completing the investigation (following instructions, answering questionnaires),\n* Suffering from a pathology (Huntington's disease, Sydenham's Chorea) preventing stable sitting posture during participation in the investigation,\n* Have undergone an amputation that prevents the BePoW device from taking measurements,\n* having undergone a tracheotomy preventing spirometry.\n* Pregnant, parturient or breast-feeding women,\n* Person deprived of liberty by a judicial decision (except guardianship or curatorship) or or administrative decision, a person under psychiatric care or admitted to a or social establishment for purposes other than research,\n* Minors,\n* Person in an emergency situation unable to give prior consent."}, 'identificationModule': {'nctId': 'NCT06239012', 'acronym': 'SAPA', 'briefTitle': 'Reliability and Validity Evaluation of the BePoW Device', 'organization': {'class': 'OTHER', 'fullName': 'Pôle Saint Hélier'}, 'officialTitle': 'SAPA Study (Seated Posture Analysis System) : Reliability and Validity Evaluation of the BePoW Device', 'orgStudyIdInfo': {'id': '2023-A00609-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'position measurement with BePoW device compared with MCPAA scale measurements', 'description': 'Each patient will have position measurement with BePoW device and, at the same time, will have MCPAA scale measurements', 'interventionNames': ['Device: Position measurement with BePow', 'Other: Position measurement with MCPAA scale']}], 'interventions': [{'name': 'Position measurement with BePow', 'type': 'DEVICE', 'description': '14 measurements taken with the device', 'armGroupLabels': ['position measurement with BePoW device compared with MCPAA scale measurements']}, {'name': 'Position measurement with MCPAA scale', 'type': 'OTHER', 'description': 'MCPAA : measurement of seated postural control in adults in French 12 measurements taken with the goniometer', 'armGroupLabels': ['position measurement with BePoW device compared with MCPAA scale measurements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35000', 'city': 'Rennes', 'state': 'Brittany Region', 'country': 'France', 'facility': 'Pôle Saint Hélier', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pôle Saint Hélier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}