Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-02-24 @ 3:14 PM
Study NCT ID:
NCT05316766
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2022-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-user Touch Surfaces for Promoting Social Participation and Self-efficacy in Upper-limb Stroke Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2022-03-02', 'studyFirstSubmitQcDate': '2022-03-30', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Action Research Arm Test (change between three time frames )', 'timeFrame': 'Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)', 'description': 'Hand Function'}, {'measure': 'Box and Blocks (change between three time frames)', 'timeFrame': 'Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)', 'description': 'Coordination'}, {'measure': 'Dynamometer (change between three time frames)', 'timeFrame': 'Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)', 'description': 'Strength'}, {'measure': 'Nine Hole Peg Test (change between three time frames)', 'timeFrame': 'Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)', 'description': 'Fine motor skills'}, {'measure': 'Motor Activity Log (change between three time frames)', 'timeFrame': 'Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)', 'description': 'Quantity and Quality of movement everyday activities'}, {'measure': 'Reaching Performance Scale in Stroke (change between three time frames)', 'timeFrame': 'Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)', 'description': 'Quality of movement'}, {'measure': 'Fugl-Meyer Assessment (change between three time frames)', 'timeFrame': 'Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)', 'description': 'Range of movement'}, {'measure': 'Stroke Self-Efficacy Questionnaire (change between three time frames)', 'timeFrame': 'Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)', 'description': 'Self-efficacy, minimum 0 maximum 130, higher score means better outcome'}], 'secondaryOutcomes': [{'measure': "Beck's Depression (change between three time frames)", 'timeFrame': 'Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)', 'description': 'Depressive symptoms'}, {'measure': "Social Interaction category of ''Functional Limitation Profile'' (specific name of the scale) (change between three time frames)", 'timeFrame': 'Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)', 'description': 'Social Interaction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Social Interaction', 'Self Efficacy', 'Stroke', 'Motor Activity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of conventional therapy with a framework intervention for upper limb motor rehabilitation based on the promotion of self-efficacy and social participation/interaction through a multi-user touch surface', 'detailedDescription': 'After signing the written informed consent about participating in the study, participants will be assessed for exclusion criteria and their motor, social and depression skills prior to intervention. After this, they will undergo a 12 sessions treatment for 4 weeks in groups of three, randomly distributed for a control group and experimental group. At the end of the intervention, participants will be assessed in the same manner as before the intervention. One month after the end of the intervention, participants will be assessed for follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Stroke survivor\n\nExclusion Criteria:\n\n* Unable to write and read\n* Hemispatial neglect\n* Previous upper limb motor deficits/lesions that still interfere with function\n* History of drugs/alcohol abuse\n* Aphasia with difficulties understanding oral communication and/or unability to express orally\n* Token equal or under 17\n* ARAT score lower than 10 or higher than 54\n* Botulinic toxin treatment in the last 4 months\n* Beck's Depression Inventory higher than 31"}, 'identificationModule': {'nctId': 'NCT05316766', 'briefTitle': 'Multi-user Touch Surfaces for Promoting Social Participation and Self-efficacy in Upper-limb Stroke Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Universidade da Madeira'}, 'officialTitle': 'Multi-user Touch Surfaces for Promoting Social Participation and Self-efficacy in Upper-limb Stroke Rehabilitation', 'orgStudyIdInfo': {'id': 'UMadeira'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Will receive intervention through the multi-user touch surface', 'interventionNames': ['Other: Physical rehabilitation interactive table']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual', 'description': 'This will receive conventional therapy', 'interventionNames': ['Other: Physical rehabilitation']}], 'interventions': [{'name': 'Physical rehabilitation', 'type': 'OTHER', 'description': 'Exercises to rehabilitate upper limb strength, coordination and range of movement, based on conventional therapy', 'armGroupLabels': ['Treatment as usual']}, {'name': 'Physical rehabilitation interactive table', 'type': 'OTHER', 'description': 'Exercises to rehabilitate upper limb strength, coordination and range of movement, based on multi-user touch surface', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000-232', 'city': 'Funchal', 'state': 'Madeira', 'country': 'Portugal', 'facility': 'ARDITI', 'geoPoint': {'lat': 32.66568, 'lon': -16.92547}}], 'overallOfficials': [{'name': 'Sergi B Badia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade da Madeira', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sergi Bermúdez i Badia', 'investigatorAffiliation': 'Universidade da Madeira'}}}}