Efficacy of Early Task-Oriented Rehabilitation in Acute Stroke Recovery

NCT07311304 | Not Yet Recruiting

• 1 other identifier: Task-Oriented Rehabilitation
• Study Type: interventional
• Target: 158
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke

Keywords

Task-Oriented Rehabilitation; Early Rehabilitation; Stroke Recovery; Neurorehabilitation; Physical Therapy; Motor Function; Ischemic Stroke; Hemorrhagic Stroke; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment (FMA, Motor Domain)

  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 Outcomes (2)

• Stroke Impact Scale (SIS)

  Baseline (pre-intervention) At hospital discharge (Day 7-14 after admission) 3 months after hospital discharge

• Modified Rankin Scale (mRS)

  Baseline (pre-intervention) At hospital discharge (Day 7-14 after admission) 3 months after hospital discharge

Study Arms (2)

Experimental: Task-Oriented Rehabilitation

EXPERIMENTAL

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

Active Comparator: Traditional Physiotherapy Rehabilitation

ACTIVE COMPARATOR

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

Interventions

Task-Oriented Rehabilitation BEHAVIORAL

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.

Experimental: Task-Oriented Rehabilitation

Traditional Physiotherapy Rehabilitation BEHAVIORAL

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.

Active Comparator: Traditional Physiotherapy Rehabilitation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• Winstein CJ, Wolf SL, Dromerick AW, Lane CJ, Nelsen MA, Lewthwaite R, Cen SY, Azen SP; Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Investigative Team. Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke: The ICARE Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):571-81. doi: 10.1001/jama.2016.0276.

  PMID: 26864411 BACKGROUND

• French B, Thomas LH, Leathley MJ, Sutton CJ, McAdam J, Forster A, Langhorne P, Price CI, Walker A, Watkins CL. Repetitive task training for improving functional ability after stroke. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006073. doi: 10.1002/14651858.CD006073.pub2.

  PMID: 17943883 BACKGROUND

• Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.

  PMID: 27145936 BACKGROUND

• Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.

  PMID: 21571152 BACKGROUND

• Page SJ, Gater DR, Bach-Y-Rita P. Reconsidering the motor recovery plateau in stroke rehabilitation. Arch Phys Med Rehabil. 2004 Aug;85(8):1377-81. doi: 10.1016/j.apmr.2003.12.031.

  PMID: 15295770 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Mariam Asaad Fahmy, Principal Investigator

CONTACT

+201018198423; Mariam.17289868@med.aun.edu.eg

Study Design

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

Study Record Dates

• First Submitted: September 27, 2025
• First Posted: December 30, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12