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Post-stroke Nurse-led Rehabilitation to Improve Functional Activity and Community Participation in Bangladesh

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated April 7, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary endpoint(s) modifiedv2 Show 6 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Jan 30, 2026 to Feb 5, 2026
    • Interventions: in daily everyday routine practice (Device) to in daily routine practice (Device)
    • Secondary endpoints revised (5)
    • Study description shortened, about 10 words
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Hiroshima University
14 trials monitored
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Stroke
3,531 trials monitored
See 153 trials at risk
Stroke causes various levels of disability which decreases physical function for a prolonged period. The purpose of this study is to evaluate the effectiveness of a nurse-led rehabilitation program including a multidisciplinary team focused on improving the functional ability among post-stroke patients in Bangladesh. A prospective, open-label (1:1) randomized controlled trial (RCT) will be conducted at the National Institute of Neuroscience \& Hospital (NINS\&H) in Dhaka, Bangladesh from January 2026 to September 2026. Participants will be the post-stroke patients who got discharged from NINS\&H within 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 166. The intervention will be designed to provide the 6-months Nurse-led rehabilitation program including a multidisciplinary team 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 primary outcome is improved activity and participation measured by the Functional Independence Measurement (FIM). The secondary outcomes are improved motor function, self-efficacy, emotional status and participation ability. The endpoints will be compared at baseline, 3rd and 6th months. We assume that patients receiving rehabilitation education and assistive device progress to achieve an optimal level of independence, with improved motor function, emotional status and participation ability to re-integrate into society.
Trial Details
NCT Number NCT07384650
Lead Sponsor Hiroshima University
Conditions
(from sponsor)		 Stroke
Related terms Stroke
Enrollment 166 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov