Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT06173635
Status:
COMPLETED
Last Update Posted:
2024-08-14
First Post:
2023-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison Study of the Maxi Move 5 (MM5) Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2023-10-23', 'studyFirstSubmitQcDate': '2023-12-07', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Time to complete each transfer will be recorded', 'timeFrame': 'up to 24 months', 'description': 'Time to complete each activity and each task within the activity will be measured in seconds.'}, {'measure': '2. A detailed hierarchical task analysis (HTA) of each activity will be completed using the video recordings and experimenter field notes for each transfer to asses the number of correct placements for each device.', 'timeFrame': 'up to 24 months', 'description': 'Correct placement will be visually controlled with the use of markers on the subject and the final positioning device (e.g chair, toilet or bed) for each transfer. This will be reported as distance from the ideal position.'}, {'measure': '3. Physical load for movement of the hoist throughout the activities for each device will be measured.', 'timeFrame': 'up to 24 months', 'description': 'Force required to complete the range of patient and hoist positioning tasks, forward, backwards, rotation movement, patient positioning etc. These forces will be used with the HTA data to calculate the amount of physical force delivered by the participants with each device and each transfer. The forces used will be presented in newton.'}, {'measure': '4 Collect subjective data from the caregivers that describe, comfort, ease of use, effort and willingness to adopt in practice, etc', 'timeFrame': 'up to 24 months', 'description': 'This will be collected by the use of questionnaires'}, {'measure': '5 Subjective responses from the expert patient being transferred will be recorded', 'timeFrame': 'up to 24 months', 'description': 'This will be collected by the use of questionnaires'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This trial aims to evaluate the added improvements from a caregiver and patient benefit perspective.\n\nThe trial should identify the forces involved for the caregiver when manoeuvring the lift.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor expert patient:\n\n* ≥18 years\n* Healthy male or female\n* 80-100 kg\n\n 24 healthy volunteers (caregivers) will be recruited. They will require a strong working knowledge of passive floor lifts and patient positioning with the use of loop and clip slings.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06173635', 'briefTitle': 'A Comparison Study of the Maxi Move 5 (MM5) Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arjo AB'}, 'officialTitle': 'A Laboratory Trial to Explore the Benefits of the New Maxi Move 5 (MM5) Technology', 'orgStudyIdInfo': {'id': 'MaxiMove5-MACC-001-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Maxi Move 5', 'description': '24 healthy volunteers will evaluate all 5 devices', 'interventionNames': ['Device: Maxi Move 5']}], 'interventions': [{'name': 'Maxi Move 5', 'type': 'DEVICE', 'description': '4 comparative devices will be used to evaluate the MM5 device', 'armGroupLabels': ['Maxi Move 5']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Loughborough', 'country': 'United Kingdom', 'facility': 'School of Design and Creative Art at Loughborough University', 'geoPoint': {'lat': 52.76667, 'lon': -1.2}}], 'overallOfficials': [{'name': 'Karin Hannander', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Arjo AB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arjo AB', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Loughborough University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}