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Post-discharge Nurse-led Rehabilitation to Improve Functional Activity and Community Participation Among Stroke-Patients in Bangladesh: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years old and above, both males \& females,

• Irrespective of the type of stroke and time of stroke,

• mRS 2-4 with disability on upper and/or lower limb(s)

• Physician advice on rehabilitation, and who needs assistive devices for ADL,

• Having a phone, and

• Willing to provide consent \& participate in the study.

Locations
Other Locations
Bangladesh
National Institute of Neuroscience and Hospital
RECRUITING
Dhaka
Contact Information
Primary
Michiko Moriyama, RN, PhD
morimich@hiroshima-u.ac.jp
+8182-257-5365
Backup
Co-Principal Investigator, K A T M Ehsanul Huq, PhD, MD/MBBS
ehsan@hiroshima-u.ac.jp
Co-Principal Investigator
Time Frame
Start Date: 2026-02-05
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 166
Treatments
Experimental: Health Education and assistive devices
Participants will be trained in self-care with stroke disabilities (e.g. eating, grooming, bathing, dressing, toileting), physical exercise, lifestyle modification, prevention of complications after stroke through researcher developed Health booklet. Based on their disabilities, some assistive and exercise devices will be provided to them for improving functional independence.~After discharge they will be educated and followed by RA nurses through tele services for 6 months. The nurses will contact the participants periodically over the telephone, and follow up on their regular self-care activities, adjustment to devices, exercise and participatory behavior.
No_intervention: No education or Devices
The participants in CG will not receive Education booklet or assistive device . They will receive the usual rehabilitation education from the hospital.
Related Therapeutic Areas
Sponsors
Leads: Hiroshima University

This content was sourced from clinicaltrials.gov