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NCT06786559Not yet recruiting

Nurse-led Rehabilitation to Improve Self-care Among Stroke Patients in Bangladesh

Post Discharge Nurse-led Rehabilitation to Improve Self-care Among Stroke Patients in Bangladesh: A Pilot Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 22 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
64 (estimated)
First submitted
6 Jan 2025
Start date
1 Mar 2025
Primary completion date
30 Aug 2025
Lead sponsor
Hiroshima University
Diseases
Stroke
NCT number
NCT06786559

What you commit to

  • Study type: Interventional
  • Planned participants: 64
  • From 1 Mar 2025 to the primary completion date, 30 Aug 2025
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • For patient
    • Participation in other clinical trials,
    • not having a smartphone at home, For family care giver No exclusion criteria

Who the study is looking for

  • 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
    • Physician advice rehabilitation, and who needs assistive devices for ADL,
    • has family caregivers,
    • lives in the study area, and
    • who will provide written consent \& willing to participate in the study.
    • For family care giver
  • Primary caregivers irrespective of sex and aged 18 years old and above, living with the patient who take care of an above patient and who meets all the inclusion criteria.
  • Who will provide written consent \& willing to participate in the study

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.