- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07272759
Feasibility Study of Occupation-Based 'Remediation, Education, Adaptation, Promotion' (REAP) Program Among People With Stroke in Bang
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.
The 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.
This 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Dhaka, Bangladesh
- Centre for the Rehabilitation of the Paralysed (CRP)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18-64 years,
- Diagnosed with stroke (ischemic/hemorrhagic) 3-24 months prior,
- Medically stable and able to provide informed consent,
- MoCA score ≥18.
Exclusion Criteria:
- Severe receptive aphasia,
- Major psychiatric disorders,
- Unstable medical conditions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Stroke patients who are taking rehabilitation
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.
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The REAP program consists of four core components designed to address the complex needs of stroke survivors:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Barthel Index
Time Frame: From enrollment to 12 weeks
|
Assesses independence in activities of daily living (ADLs).
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From enrollment to 12 weeks
|
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Montreal Cognitive Assessment (MoCA)
Time Frame: Enrollment to 12 weeks
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Screens for cognitive impairment.
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Enrollment to 12 weeks
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Bangladeshi Occupational Self-Assessment - Short Form (BOSA-SF) (
Time Frame: Enrollment to 12 weeks
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Evaluates perceived occupational competence and values within the local context.
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Enrollment to 12 weeks
|
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Fugl-Meyer Assessment (FMA)
Time Frame: Enrollment to 12 weeks
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Assesses motor recovery post-stroke
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Enrollment to 12 weeks
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Occupational Balance Questionnaire
Time Frame: Enrollment to 12 weeks
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Measures balance between different occupational areas in everyday life.
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Enrollment to 12 weeks
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Life Satisfaction Questionnaire (LiSat-11)
Time Frame: Enrollment to 12 weeks
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Assesses subjective life satisfaction across various domains
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Enrollment to 12 weeks
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Zarit Caregiver Burden Scale
Time Frame: Enrollment to 12 weeks
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Assesses the level of burden experienced by informal caregivers
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Enrollment to 12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Peter Bontje, PhD, Tokyo Metropolitan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Stroke
- Physiological Phenomena
- Socioeconomic Factors
- Population Characteristics
- Biological Phenomena
- Adaptation, Physiological
- Adaptation, Biological
- Educational Status
- Acclimatization
Other Study ID Numbers
- CRP-ERC-R&E-0401-0479
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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