Efficacy of Early Task-Oriented Rehabilitation in Acute Stroke Recovery

December 21, 2025 updated by: Mariam Asaad Fahmy, Assiut University

A Randomized Controlled Trial on the Efficacy of Early Task-Oriented Rehabilitation in Acute Stroke Recovery Compared to Traditional Rehabilitation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Task-Oriented Rehabilitation
Participants receive a structured task-oriented rehabilitation program emphasizing functional, goal-directed activities. Examples include upper-limb tasks (reaching, grasping, buttoning, simulated self-care), lower-limb tasks (sit-to-stand, gait training, stair climbing), and balance tasks (carrying a tray, obstacle negotiation). Sessions occur 3-4 times per week, 45-60 minutes each, during hospitalization and continued as outpatient follow-up. Progression is graded by difficulty, repetitions, and patient tolerance.
Behavioral: Task-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.
Active Comparator: Active Comparator: Traditional Physiotherapy Rehabilitation
Participants receive conventional physiotherapy including stretching, range-of-motion exercises, muscle activation techniques, balance training, core stability exercises, and functional mobility training. Sessions occur 3-4 times per week, 45-60 minutes each, during hospitalization and continued as outpatient follow-up.
Behavioral: Traditional 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment (FMA, Motor Domain)
Time Frame: 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..
Baseline (pre-intervention) At hospital discharge (Day 7-14 after admission) 3 months after hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke Impact Scale (SIS)
Time Frame: 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.
Baseline (pre-intervention) At hospital discharge (Day 7-14 after admission) 3 months after hospital discharge
Modified Rankin Scale (mRS)
Time Frame: 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.
Baseline (pre-intervention) At hospital discharge (Day 7-14 after admission) 3 months after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

September 27, 2025

First Submitted That Met QC Criteria

December 21, 2025

First Posted (Actual)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 21, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Task-Oriented Rehabilitation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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