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

NCT07384650 | Not Yet Recruiting DMC

• 1 other identifier: IRB/NINS/2025/535
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Stroke; rehabilitation; functional activity; participation

Outcome Measures

Primary Outcomes (1)

• Improved Functional Activity

  It will be measured by Functional Independence Measurement (FIM). The FIM was developed in 1983 by a task force from the American Congress of Rehabilitation Medicine (ACRM) and the American Academy of Physical Medicine and Rehabilitation (AAPM\&R) \[23\]. The Bengali version of the scale was implemented among the functionally disabled patients in Bangladesh and found to be valid and reliable (α = 0.97) \[24\]. This scale has 18 items from level 1-total assistance to level 7-complete independence. This scale consists of 2 sub-scales including physical (13 items) and cognitive (5 items) domains. The physical domain score ranges from 13-91 and the cognitive domain score ranges from 5-35. The total score range is from 18-126. The higher the score, the better the level of independence.

  6 months

Secondary Outcomes (5)

• Rehabilitation adherence

  6 months

• Improved motor function

  6 months

• Improved self-efficacy

  6 months

• Improved emotional status

  6 months

• Improved participation abilities

  6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Device: in daily everyday routine practice

Control Group

NO INTERVENTION

The participants in CG will not receive "Education booklet" or assistive device . They will receive the usual rehabilitation education from the hospital.

Interventions

in daily everyday routine practice DEVICE

Participants will be provided with education booklet and assistive devices for implement in their daily life to improve their functional activity.

Also known as: Education Booklet

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participation in other clinical trials,
• Planning to receive institutional rehabilitation services, and
• Cannot communicate (having speech difficulties).

Sponsors & Collaborators

• Hiroshima University: lead

Study Sites (1)

National Institute of Neuroscience and Hospital

Dhaka, Dhaka Division, 1207, Bangladesh

Location

Related Publications (1)

• Feigin VL, Brainin M, Norrving B, Martins SO, Pandian J, Lindsay P, F Grupper M, Rautalin I. World Stroke Organization: Global Stroke Fact Sheet 2025. Int J Stroke. 2025 Feb;20(2):132-144. doi: 10.1177/17474930241308142. Epub 2025 Jan 3.

  PMID: 39635884 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Salma Akhter

  Hiroshima University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michiko Moriyama, RN, PhD

CONTACT

+8182-257-5365; morimich@hiroshima-u.ac.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 3, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

BA (1)