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Not yet recruitingNCT07311304Updated Dec 30, 2025

Efficacy of Early Task-Oriented Rehabilitation in Acute Stroke Recovery

An interventional study of Task-Oriented Rehabilitation and Traditional Physiotherapy Rehabilitation in Stroke, Ischemic Stroke and Hemorrhagic Stroke, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-30.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
158
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • 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
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In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 158 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
158 participants (estimated)

Study arms

  • 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

  • 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

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.

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What researchers measure

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..

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

Secondary outcomes

  1. Stroke Impact Scale (SIS)

    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.

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

  2. Modified Rankin Scale (mRS)

    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.

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 26864411 ↗
  • French B, Thomas LH, Coupe J, McMahon NE, Connell L, Harrison J, Sutton CJ, Tishkovskaya S, Watkins CL. Repetitive task training for improving functional ability after stroke. Cochrane Database Syst Rev. 2016 Nov 14;11(11):CD006073. doi: 10.1002/14651858.CD006073.pub3. PubMed 27841442 ↗
  • 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. PubMed 27145936 ↗
  • Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5. PubMed 21571152 ↗
  • 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. PubMed 15295770 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07311304
Lead sponsor
Assiut University
Responsible party
Mariam Asaad Fahmy (Researcher, Assiut University) — Principal investigator
First posted
Dec 30, 2025
Start date
Jan 1, 2026 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Dec 30, 2025

Study contacts

Mariam Asaad Fahmy, Principal Investigator
Contact
Mariam.17289868@med.aun.edu.eg
+201018198423

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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