Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-29 @ 9:14 AM
Study NCT ID:
NCT07272759
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Occupation-Based 'Remediation, Education, Adaptation, Promotion' (REAP) Program Among People With Stroke in Bang
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': 'D004522', 'term': 'Educational Status'}, {'id': 'D000064', 'term': 'Acclimatization'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D000222', 'term': 'Adaptation, Physiological'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D000220', 'term': 'Adaptation, Biological'}, {'id': 'D001686', 'term': 'Biological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Barthel Index', 'timeFrame': 'From enrollment to 12 weeks', 'description': 'Assesses independence in activities of daily living (ADLs).'}, {'measure': 'Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'Enrollment to 12 weeks', 'description': 'Screens for cognitive impairment.'}, {'measure': 'Bangladeshi Occupational Self-Assessment - Short Form (BOSA-SF) (', 'timeFrame': 'Enrollment to 12 weeks', 'description': 'Evaluates perceived occupational competence and values within the local context.'}, {'measure': 'Fugl-Meyer Assessment (FMA)', 'timeFrame': 'Enrollment to 12 weeks', 'description': 'Assesses motor recovery post-stroke'}, {'measure': 'Occupational Balance Questionnaire', 'timeFrame': 'Enrollment to 12 weeks', 'description': 'Measures balance between different occupational areas in everyday life.'}, {'measure': 'Life Satisfaction Questionnaire (LiSat-11)', 'timeFrame': 'Enrollment to 12 weeks', 'description': 'Assesses subjective life satisfaction across various domains'}, {'measure': 'Zarit Caregiver Burden Scale', 'timeFrame': 'Enrollment to 12 weeks', 'description': 'Assesses the level of burden experienced by informal caregivers'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Stroke causes major disability issues in Bangladesh and often leaves people unable to look after themselves, work, or participate in family and community life. Most stroke survivors in Bangladesh do not receive adequate rehabilitation, and existing services focus mainly on physical exercises, not on helping people return to meaningful activities.\n\nThe REAP programme is a new therapy approach that remediates skills through structured training, educates patients and families on stroke management, adapts tasks or environments to make daily activities easier, and promotes participation in meaningful roles and activities.\n\nThis study will test whether the REAP programme can be delivered successfully in a Bangladeshi rehabilitation centre, whether patients find it acceptable, and whether it helps people become more independent and improves quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-64 years,\n* Diagnosed with stroke (ischemic/hemorrhagic) 3-24 months prior,\n* Medically stable and able to provide informed consent,\n* MoCA score ≥18.\n\nExclusion Criteria:\n\n* Severe receptive aphasia,\n* Major psychiatric disorders,\n* Unstable medical conditions'}, 'identificationModule': {'nctId': 'NCT07272759', 'briefTitle': "Feasibility Study of Occupation-Based 'Remediation, Education, Adaptation, Promotion' (REAP) Program Among People With Stroke in Bang", 'organization': {'class': 'OTHER', 'fullName': 'Tokyo Metropolitan University'}, 'officialTitle': "Feasibility Study of Occupation-Based 'Remediation, Education, Adaptation, Promotion' (REAP) Program Among People With Stroke in Bang", 'orgStudyIdInfo': {'id': 'CRP-ERC-R&E-0401-0479'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stroke patients who are taking rehabilitation', 'description': 'Stroke patients aged 18-64 years, diagnosed with stroke (ischemic/hemorrhagic) 3-6 months prior, medically stable and able to provide informed consent, MoCA score ≥18.', 'interventionNames': ["Other: Occupation-Based 'Remediation, Education, Adaptation, Promotion' (REAP) Program"]}], 'interventions': [{'name': "Occupation-Based 'Remediation, Education, Adaptation, Promotion' (REAP) Program", 'type': 'OTHER', 'description': 'The REAP program consists of four core components designed to address the complex needs of stroke survivors:\n\n1. Remediation\n2. Education\n3. Adaptation\n4. Promotion', 'armGroupLabels': ['Stroke patients who are taking rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'Centre for the Rehabilitation of the Paralysed (CRP)', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'overallOfficials': [{'name': 'Peter Bontje, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tokyo Metropolitan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tokyo Metropolitan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre for the Rehabilitation of the Paralysed, Bangladesh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Azharul Islam', 'investigatorFullName': 'Azharul Islam', 'investigatorAffiliation': 'Tokyo Metropolitan University'}}}}