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

NCT06786559 | Not Yet Recruiting DMC

• 1 other identifier: 392
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stroke; Disability Physical

Keywords

Stroke; Disability; Rehabilitation; Assistive device; Self-Care; Care Burden

Outcome Measures

Primary Outcomes (1)

• Change in the functional independence of activity of daily living

  Functional Independence Measurement (FIM) tool will be used. This scale has 18 items from level 1-Total assistance to level 7- Complete independence. The total score is 126, the lowest score is 18. A higher score means improved functional independence level and lower score means less functional independence.

  3 months

Secondary Outcomes (3)

• Patient's Self-efficacy

  3 months

• Patient's Social participation

  3 months

• Family Care burden

  3 months

Study Arms (2)

Assistive Device Intervention

EXPERIMENTAL

Patients and caregivers 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 adjustive and exercise devices will be provided to them for improving functional independence.

Behavioral: Assistive Device and health Education

Control Group

NO INTERVENTION

No "Education booklet" or adjustive device are provided to them. The patients with family caregivers in control group will receive the usual care.

Interventions

Assistive Device and health Education BEHAVIORAL

After discharge they will be assessed and followed by RA nurses through home visit and tele services for 2 months. The nurses will contact the patients periodically over telephone, and follow up their regular self-care activities, adjustment to devices, exercise and adaptive behavior.

Assistive Device Intervention

Eligibility Criteria

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

You may qualify if:

• 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
• Who will provide written consent \& willing to participate in the study

You may not qualify if:

• For patient
• Participation in other clinical trials,

Sponsors & Collaborators

• Hiroshima University: lead

Related Publications (4)

• Laver KE, Adey-Wakeling Z, Crotty M, Lannin NA, George S, Sherrington C. Telerehabilitation services for stroke. Cochrane Database Syst Rev. 2020 Jan 31;1(1):CD010255. doi: 10.1002/14651858.CD010255.pub3.

  PMID: 32002991 BACKGROUND

• Prvu Bettger J, Liu C, Gandhi DBC, Sylaja PN, Jayaram N, Pandian JD. Emerging Areas of Stroke Rehabilitation Research in Low- and Middle-Income Countries: A Scoping Review. Stroke. 2019 Nov;50(11):3307-3313. doi: 10.1161/STROKEAHA.119.023565. Epub 2019 Oct 17. No abstract available.

  PMID: 31619149 BACKGROUND

• Rahman S, Sarker S, Haque AKMN, Uttsha MM, Islam MF, Deb S. AI-Driven Stroke Rehabilitation Systems and Assessment: A Systematic Review. IEEE Trans Neural Syst Rehabil Eng. 2023;31:192-207. doi: 10.1109/TNSRE.2022.3219085. Epub 2023 Jan 30.

  PMID: 36327176 BACKGROUND

• Kim DY, Ryu B, Oh BM, Kim DY, Kim DS, Kim DY, Kim DK, Kim EJ, Lee HY, Choi H, Kim HS, Lee HH, Kim HJ, Oh HM, Seok H, Park J, Park J, Park JG, Kim JM, Lee J, Shin JH, Lee JK, Oh JS, Park KD, Kim KT, Chang MC, Chun MH, Kim MW, Kang MG, Song MK, Choi M, Ko MH, Kim NY, Paik NJ, Jung SH, Yoon SY, Lim SH, Lee SJ, Yoo SD, Lee SH, Yang SN, Park SW, Lee SY, Han SJ, Lee SJ, Bok SK, Ohn SH, Im S, Pyun SB, Hyun SE, Kim SH, Ko SH, Jee S, Kwon S, Kim TW, Chang WH, Chang WK, Yoo WK, Kim YH, Yoo YJ, Kim YW, Shin YI, Park YG, Choi YH, Kim Y; KSNR Stroke CPG Writing Group. Clinical Practice Guideline for Stroke Rehabilitation in Korea-Part 1: Rehabilitation for Motor Function (2022). Brain Neurorehabil. 2023 Jul 17;16(2):e18. doi: 10.12786/bn.2023.16.e18. eCollection 2023 Jul.

  PMID: 37554256 BACKGROUND

MeSH Terms

Conditions

Stroke; Caregiver Burden

Interventions

Self-Help Devices

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

Salma Akhter, PhD

CONTACT

07037923841; dncsalma@gmail.com

Dr. Mahmudul Islam, MD

CONTACT

+88 01822496267; drmahmudul@yahoo.com

Study Design

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

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 22, 2025
• Study Start: March 1, 2025
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share