Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-01-25 @ 12:06 AM
Study NCT ID:
NCT02857803
Status:
COMPLETED
Last Update Posted:
2019-10-15
First Post:
2016-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomised Controlled Trial Comparing the Impact of Virtual Reality, Paper and Pencil and Conventional Methods on Stroke Rehabilitation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010209', 'term': 'Paper'}], 'ancestors': [{'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-11', 'studyFirstSubmitDate': '2016-08-03', 'studyFirstSubmitQcDate': '2016-08-03', 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Crystallised Intelligence as assesed by Comprehension from the WAIS III', 'timeFrame': 'Baseline'}], 'primaryOutcomes': [{'measure': 'Change from baseline in the Montreal Cognitive Assessment', 'timeFrame': 'Baseline, End (4-6 weeks) and 8-weeks follow-up'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in the Trail Making Test A and B', 'timeFrame': 'Baseline, End (4-6 weeks) and 8-weeks follow-up'}, {'measure': 'Change from baseline in the Verbal Paired Associates (WMS III)', 'timeFrame': 'Baseline, End (4-6 weeks) and 8-weeks follow-up'}, {'measure': 'Change from baseline in the Digit Span (WAIS III)', 'timeFrame': 'Baseline, End (4-6 weeks) and 8-weeks follow-up'}, {'measure': 'Change from baseline in the Symbol Search and Coding (WAIS III)', 'timeFrame': 'Baseline, End (4-6 weeks) and 8-weeks follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'Cognitive Rehabilitation', 'Motor Rehabilitation', 'Ecological validity', 'Personalisation'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Faria, A. L., & Bermúdez i Badia, S. (2015). Development and evaluation of a web-based cognitive task generator for personalized cognitive training: a proof of concept study with stroke patients. In REHAB 2015: 3rd Workshop on ICTs for improving Patients Research Techniques. ACM.'}, {'type': 'BACKGROUND', 'citation': 'Faria, A. L., Vourvopoulos, A., Cameirão, M. S., Fernandes, J. C., & Bermúdez i Badia, S. (2014). An integrative virtual reality cognitive-motor intervention approach in stroke rehabilitation: a pilot study. In 10th ICDVRAT, Gothenburg, Sweden, Sept. 2-4, 2014.'}, {'type': 'BACKGROUND', 'citation': 'Vourvopoulos, A., Faria, A. L., Ponnam, K., & Bermúdez i Badia, S. (2014). RehabCity: Design and Validation of a Cognitive Assessment and Rehabilitation Tool through Gamified Simulations of Activities of Daily Living. In 11th International Conference on Advances in Computer Entertainment Technology. Funchal, Portugal.'}, {'pmid': '32546251', 'type': 'DERIVED', 'citation': 'Faria AL, Pinho MS, Bermudez I Badia S. A comparison of two personalization and adaptive cognitive rehabilitation approaches: a randomized controlled trial with chronic stroke patients. J Neuroeng Rehabil. 2020 Jun 16;17(1):78. doi: 10.1186/s12984-020-00691-5.'}], 'seeAlsoLinks': [{'url': 'http://neurorehabilitation.m-iti.org/TaskGenerator/', 'label': 'Task Generator'}]}, 'descriptionModule': {'briefSummary': 'Virtual Reality allows the integration of both cognitive and motor rehabilitation in a more ecologically valid context. The purpose of this study is to determine whether this methodology has more impact on stroke rehabilitation than a paper and pencil personalised program and conventional therapy, which is motor-focused.', 'detailedDescription': "Cognitive impairments after stroke are not always given sufficient attention despite its limitations in activities-of-daily- living (ADL's). Current cognitive rehabilitation methods mostly rely on paper-and-pencil tasks targeting isolated domains, which is not consistent with everyday-life. Besides limited ecological-validity, paper-and-pencil tasks are not accessible for most stroke patients whose dominant arm is paretic. Virtual Reality (VR) has shown to be a solution for the development of accessible and ecologically valid systems, but, does it have more impact than a paper and pencil personalised intervention?\n\nThrough a participatory design approach, with health professionals, the investigators have developed:\n\n* a motor-accessible and cognitive-personalized VR-based system, where conventional cognitive tasks were operationalized in meaningful simulations of ADL's (Reh@City) and;\n* a web tool which generates personalised paper and pencil tasks( Task Generator).\n\nThe investigators objective is to have a sample of 60 stroke patients between 40 and 70 years old, randomly allocated in three groups: the experimental group 1 were participants will perform 30 minutes of the VR training with Reh@City; the experimental group 2 were participants will perform 30 minutes of the paper and pencil training with the Task Generator, and the control group were participants will perform 30 minutes of conventional therapy (occupational therapy)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ischemic stroke with more than 6 months post-stroke\n* cognitive deficit but with enough capacity to understand the task and follow instructions with a minimum score of 11 over 17 in the Token Test (6-item version, Portuguese population)\n* able to read and write\n\nExclusion Criteria:\n\n* Neglect\n* Severe depressive symptoms as assessed by the Beck Depression Inventory'}, 'identificationModule': {'nctId': 'NCT02857803', 'briefTitle': 'A Randomised Controlled Trial Comparing the Impact of Virtual Reality, Paper and Pencil and Conventional Methods on Stroke Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Universidade da Madeira'}, 'officialTitle': 'The Impact of Using an Interactive System, a Paper and Pencil Program or Conventional Methodologies in the Rehabilitation of Stroke Patients: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '303891'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality', 'description': 'The Virtual Reality group will perform personalised activities of daily living in the context of a simulated city (Reh@City). The interaction with the virtual environment will be through a natural user interface.', 'interventionNames': ['Procedure: Virtual Reality']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paper and Pencil', 'description': 'The paper and pencil group will perform a set of cognitive paper and pencil tasks personalised to their deficits and generated automatically through a Task Generator.', 'interventionNames': ['Procedure: Paper and Pencil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Therapy', 'description': 'The Conventional Therapy group will perform the activities offered by the public health system, which are motor-focused.', 'interventionNames': ['Procedure: Conventional Therapy']}], 'interventions': [{'name': 'Virtual Reality', 'type': 'PROCEDURE', 'description': 'Intervention of 30 minutes, 3 times a week until reaching 12 sessions.', 'armGroupLabels': ['Virtual Reality']}, {'name': 'Paper and Pencil', 'type': 'PROCEDURE', 'description': 'Intervention of 30 minutes, 3 times a week until reaching 12 sessions.', 'armGroupLabels': ['Paper and Pencil']}, {'name': 'Conventional Therapy', 'type': 'PROCEDURE', 'description': 'Intervention of 30 minutes, 3 times a week until reaching 12 sessions.', 'armGroupLabels': ['Conventional Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9004-514', 'city': 'Funchal', 'state': 'Madeira', 'country': 'Portugal', 'facility': 'Serviço de Saúde da Região Autónoma da Madeira', 'geoPoint': {'lat': 32.66568, 'lon': -16.92547}}], 'overallOfficials': [{'name': 'Sergi Bermudez i Badia, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade da Madeira'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade da Madeira', 'class': 'OTHER'}, 'collaborators': [{'name': 'Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Auxiliar', 'investigatorFullName': 'Sergi Bermúdez i Badia', 'investigatorAffiliation': 'Universidade da Madeira'}}}}