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.
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,
Participation in other clinical trials,
Planning to receive institutional rehabilitation services, and
Cannot communicate (having speech difficulties).
Parallel
in daily routine practice
DeviceParticipants will be provided with education booklet and assistive devices for implement in their daily life to improve their functional activity.
Changes in 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.
Changes in rehabilitation adherence
Rehabilitation adherence will be measured by the rehabilitation adherence questionnaire which is developed by the research team, and it was validated by stroke and chronic care expert. This scale has 3 items with a 5-point Likert scale, and the score ranges from 3- 15. The higher mean score indicates greater adherence to rehabilitation.
Changes in motor function
The motor function will be measured by the Motricity Index (MI) developed by Demeurisse et al. in 1980 which is valid \& reliable (α= 0.93) \[25\]to assess the motor impairment of participants. Three movements for upper (pinch grip, PG; elbow flexion, EF; shoulder abduction, SA) and lower (ankle dorsiflexion, AD; knee extension, KE; hip flexion, HF) limbs are assessed for evaluating motor function. It is a 6-point scale for the arm and leg test; 3 points for trunk control test. A total score ranging from 0 (complete paresis) to 100 (normal strength) and is computed for each limb on both sides, and a side score can be computed by averaging upper and lower limb scores. The higher score indicates better limb function.
Changes in self-efficacy
Self-efficacy will be assessed by the generalized self-efficacy scale (GSE) (Jerusalem et al., 1981) \[26\]. This scale assessed patients' self-efficacy after experiencing post-stroke stress and the strength of an individual's belief in situations. It was translated into the Bengali version and was found valid and reliable (α = 0.7 to 0.91) \[27\]. It has a total of 10 items with a 4-point Likert scale that ranges from 1= not at all true to 4=exactly true. The lowest score is 10 and the highest score is 40. The higher score indicates better self-efficacy.
Changes in emotional status
he emotional status will be assessed using a subdomain of stroke impact scale (SIS) which is valid and reliable for assessing patient-perceived mood, emotional control, and psychological well-being following stroke \[28\]. This subdomain scale has 9 items with a 5-point Likert scale and score ranges from 9-45. Domain scores will be calculated using standard SIS scoring procedures and transformed to a 0-100 scale, with higher scores indicating less perceived impact of stroke.
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