Hemorrhagic Stroke, Ischemic Stroke, Stroke
Conditions
Keywords
Task-Oriented Rehabilitation, Early Rehabilitation, Stroke Recovery, Neurorehabilitation, Physical Therapy, Motor Function, Ischemic Stroke, Hemorrhagic Stroke, Randomized Controlled Trial
Brief summary
Stroke is one of the leading causes of long-term disability worldwide, and early rehabilitation is considered crucial for improving functional recovery. Traditional physiotherapy mainly focuses on mobility, strength, and general exercises, while task-oriented rehabilitation emphasizes practicing meaningful, goal-directed activities related to daily life. This randomized controlled trial aims to evaluate the efficacy of early task-oriented rehabilitation compared to traditional rehabilitation in acute stroke patients. Patients admitted with ischemic or hemorrhagic stroke within 48 hours will be randomly assigned to either a task-oriented rehabilitation program or conventional physiotherapy. Interventions will be delivered 3-4 times per week, 45-60 minutes per session, during hospitalization and continued in outpatient follow-up. The primary outcome will be functional independence assessed at 3 months. Secondary outcomes will include stroke severity, quality of life, and patient-reported outcomes. The findings are expected to provide evidence for improving rehabilitation strategies in Egypt.
Detailed description
Stroke represents a major health problem worldwide and is associated with long-term disability, particularly motor dysfunction of the upper and lower limbs. Early initiation of rehabilitation is believed to enhance neuroplasticity, maximize recovery, and improve independence in daily living activities. While conventional physiotherapy focuses on stretching, balance training, and strengthening exercises, task-oriented rehabilitation emphasizes practicing functional, goal-directed tasks such as reaching for objects, buttoning shirts, sit-to-stand practice, walking, and stair climbing. This study is a randomized controlled trial including 148-158 patients with acute ischemic or hemorrhagic stroke admitted to Assiut University Hospitals within 48 hours of onset. Participants will be randomly assigned to either the experimental group (early task-oriented rehabilitation) or the control group (traditional rehabilitation). Sessions will be delivered 3-4 times per week, each lasting 45-60 minutes, both during hospital stay and follow-up in outpatient clinics. The primary outcome is functional recovery assessed by the Fugl-Meyer Assessment and Functional Independence Measure (FIM) at 3 months. Secondary outcomes include NIH Stroke Scale, Modified Rankin Scale, Stroke Impact Scale, depression scores, and quality of life measures. This trial is expected to provide high-quality local evidence regarding the benefits of task-oriented rehabilitation in the acute phase of stroke recovery, which may inform clinical practice and guide rehabilitation protocols in Egypt.
Interventions
BEHAVIORALTask-Oriented Rehabilitation
A structured program of repetitive, purposeful practice of everyday functional tasks (see Arm description). Delivered by trained physiotherapists 3-4 times/week, 45-60 min/session. Assigned Arm(s): Experimental: Task-Oriented Rehabilitation.
BEHAVIORALTraditional Physiotherapy Rehabilitation
Standard physiotherapy focusing on stretching, strength activation, balance and functional mobility exercises. Delivered 3-4 times/week, 45-60 min/session. Assigned Arm(s): Active Comparator: Traditional Physiotherapy Rehabilitation.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute ischemic or hemorrhagic stroke diagnosed clinically and confirmed by imaging. * Admission to hospital or referral to outpatient clinic within 48 hours after stroke onset. * Age ≥ 18 years. * Both sexes. * Medically stable and fit for rehabilitation.
Exclusion criteria
* Severe stroke not suitable for rehabilitation. * Severe comorbidities (e.g., vital organ failure, malignancy). * Severe aphasia, or severe visual or auditory impairment interfering with training. * Severe upper limb spasticity (Modified Ashworth Scale \> 3). * Cognitive dysfunction (MMSE \< 24 for educated; \< 17 for illiterate patients). * Stroke mimics (e.g., seizures, brain tumor, CNS infection, demyelinating diseases, hypoglycemia). * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment (FMA, Motor Domain) | Baseline (pre-intervention) At hospital discharge (Day 7-14 after admission) 3 months after hospital discharge | Stroke-specific, performance-based scale assessing motor recovery after stroke. Score range: 0-100 (higher scores = better motor function). Unit of Measure: Score on a scale.. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Impact Scale (SIS) | Baseline (pre-intervention) At hospital discharge (Day 7-14 after admission) 3 months after hospital discharge | Patient-reported scale assessing physical, emotion, memory, communication, and social function. Score range: 0-100 (higher scores = better quality of life). Unit of Measure: score on a scale. |
| Modified Rankin Scale (mRS) | Baseline (pre-intervention) At hospital discharge (Day 7-14 after admission) 3 months after hospital discharge | Global disability scale assessing degree of dependence in daily activities. Score range: 0-6 (0 = no symptoms; 6 = death). Unit of Measure: Score on a scale. |
Contacts
Primary ContactMariam Asaad Fahmy, Principal Investigator
Outcome results
None listed