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Recruiting NCT07384650

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

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: in daily routine practice.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Bangladesh
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

Stroke is a significant cause of adult death and disability globally, leading to clinical, social, and economic challenges for individuals, families, and healthcare systems. Over 12 million new strokes are reported each year, with about 50% of survivors facing long-term functional impairments that affect their ability to live independently \[. Post-acute disability commonly comprises motor deficits, cognitive and perceptual dysfunction, communication disorders, and restrictions in activities of daily living (ADLs), greatly diminishing quality of life . Consequently, rehabilitation is essential in stroke management to restore function, avert complications, and support community reintegration .

Growing evidence indicates that stroke rehabilitation is most effective with a multidisciplinary team (MDT) model, incorporating physiotherapists, occupational therapists, speech-language pathologists, rehabilitation physicians, psychologists, and nurses . MDT-based rehabilitation facilitates coordinated goal setting, individualized therapy plans, and early identification of barriers to progress . When compared to non-coordinated care, systematic studies and clinical guidelines consistently show that planned and interdisciplinary stroke care improves functional outcomes, lowers mortality, and increases the chance of returning home after stroke.

Post-acute rehabilitation, following medical stabilization, is vital for enhancing neuroplasticity as targeted interventions during this phase can improve motor function, cognitive function, and functional independence . Patients receiving intensive post-acute therapy exhibited significantly better gains in mobility, self-care, and participation outcomes over 12 weeks compared to lower-intensity groups . Studies found that combining cognitive-motor therapy with traditional MDT practice improved executive function and ADL performance across a 6-week period. These findings underscore the value of holistic MDT programs in addressing the multidimensional impairments common in stroke survivors.

Adherence to rehabilitation is a behavior that indicates the patient's commitment to and willingness to engage in the planned therapy regimen and treatment to improve daily living activities, quality of life, and outcomes as well as prevent complications and recurrence of stroke. Treating chronic illnesses like stroke, adherence to long-term therapies, particularly rehabilitation, is a significant healthcare challenge. Digital health approaches like tele-services with personalized advice, emotional support, and time influences for enhancing rehabilitation adherence in stroke patients as relevant quality feedback significantly improves adherence. Medical experts emphasize that key determinants of adherence in out-of-hospital rehabilitation include access to tele-rehabilitation, tele-medical resources, and active participation from outpatient clinics highlighting the need for attention to both in- and out-of-hospital rehabilitation. For effective rehabilitation, a reliable scale to measure patient adherence to the regimen is essential.

Nurse-led rehabilitation and care for stroke patients combined with a multidisciplinary team significantly improves motor recovery, functional independence (ADL), and quality of life and self-management when compared to standard care. Acute care, rehabilitation, discharge, and community/home-based follow-up can all be bridged by nurse-led programs, which are typically feasible, effective, and acceptable .

In LMICs including Bangladesh, there is a lack of institutional acute, post-acute and long-term rehabilitation services available after receiving acute care management from the hospital . Patients with disabilities who need rehabilitation suffer due to inadequate healthcare infrastructure and financial resources . As there are insufficient post-stroke institutional services available in Bangladesh, home-based stroke rehabilitation could be an alternative way to play a vital role in ensuring continuity of care and supporting functional recovery within patients' home environments.

Therefore, this study will explore the effectiveness of a structured nurse-led multidisciplinary post-acute rehabilitation program. This study would provide more rigorous evidence on whether coordinated, team-based rehabilitative interventions significantly enhance functional independence compared to conventional rehabilitation approaches in Bangladesh. The findings could guide clinical practice standards, support the development of optimized rehabilitation pathways for stroke survivors and reform health-care policy for the disabled.

Interventions

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

Primary outcome measures

  • Changes in Functional Activity [Time frame: 6 months]
Secondary outcome measures (5)
  • Changes in rehabilitation adherence [Time frame: 6 months]
  • Changes in motor function [Time frame: 6 months]
  • Changes in self-efficacy [Time frame: 6 months]
  • Changes in emotional status [Time frame: 6 months]
  • Changes in participation abilities [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Bangladesh · 1 center
  • National Institute of Neuroscience and Hospital — Dhaka

Publications

  • 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

Identifiers

NCT: NCT07384650 · IRB/NINS/2025/535

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗