Nurse-led Rehabilitation to Improve Self-care Among Stroke Patients in Bangladesh
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHiroshima University
About this trial
Stroke causes various levels of disability, which decreases physical function for a prolonged period. The purpose of this study is to test the feasibility and efficacy of a nurse-led rehabilitation program focused on improving the activity of daily living (ADL) among post-stroke patients in Bangladesh. A feasibility study, including descriptive and randomized controlled trial (RCT), will be conducted at the National Institute of Neuroscience \& Hospital (NINS\&H) in Dhaka, Bangladesh, from March 2025 to August 2025. Participants will be the post-stroke patients who got discharged from NINS\&H from 5th days to 2 weeks after the onset of stroke and the family caregivers of the patients and meet the inclusion criteria. The sample size will be calculated based on G-Power analysis with a medium effect size and will be 64. The intervention will be designed to provide the 3-month nurse-led rehabilitation program regarding self-care and the use of assistive devices. Assessment for rehabilitation will be performed by the multidisciplinary team with research nurses (RA nurses), physiotherapists (PT), and occupational therapists (OT). The control group will receive the usual care. The Functional Independence Measure (FIM) measures the primary outcome as improved self-care. The secondary outcomes are self-efficacy and participation in social activities for patients and the care burden of family caregivers. We also qualitatively describe changes and improvements of cognitive, emotional, and behavioral aspects among patients and their families. The endpoints will be compared at baseline and the 3rd month. Rehabilitation with proper assistive devices may improve self-dependence, ADL, and social participation. The caregiver's burden will decrease through the implementation of self-care education and assistive devices for daily life adjustment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
For Patient
who is 18 years old and above, both males & females,
is irrespective of type of stroke and time of stroke,
is within 5 days to 2 weeks of onset of the current stroke
Disqualifiers
For patient
Participation in other clinical trials,
not having a smartphone at home, For family care giver No exclusion criteria
Trial design
Design model
Parallel
Treatments tested in this trial
Assistive Device and health Education
BehavioralAfter discharge they will be assessed and followed by RA nurses through home visit and tele services for 2 months. The nurses will contact the patients periodically over telephone, and follow up their regular self-care activities, adjustment to devices, exercise and adaptive behavior.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Assistive Device InterventionExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in the functional independence of activity of daily living
Functional Independence Measurement (FIM) tool will be used. This scale has 18 items from level 1-Total assistance to level 7- Complete independence. The total score is 126, the lowest score is 18. A higher score means improved functional independence level and lower score means less functional independence.
Time frame
3 monthsSecondary outcomes
1
Patient's Self-efficacy
Generalized self-efficacy scale (GSE) will be used to assess the strength of an individual's belief in oneself in difficult situations. The Scale has a total of 10 items with four-point Likert scale range from 1= not at all true to 4= Exactly true. After calculating the sum score, the total score will indicate the efficacy of participants. The lowest score is 10 \& highest score is 40. Higher scores indicate higher self-efficacy.
Time frame
3 months2
Patient's Social participation
Social participation scale (short simplified) with 13 items will be used to assess the person's interaction and participation in community life as it measures the severity of social participation restrictions. The scale score ranges from 0-No restriction to 70- Extreme restriction. The higher score indicates more restriction in social participation.
Time frame
3 months3
Family Care burden
Zarit Caregiver Burden Assessment (12-items) will be used to reflect how people sometimes feel when taking care of another person. Maximum score-48, minimum score-12, higher score indicates more burden.
Time frame
3 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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