StrokeNCT07311304
Efficacy of Early Task-Oriented Rehabilitation in Acute Stroke Recovery
A study testing Task-Oriented Rehabilitation and Traditional Physiotherapy Rehabilitation in people with Stroke and Ischemic Stroke, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
- What is being tested?
- Task-Oriented Rehabilitation and Traditional Physiotherapy Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Conditions
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
- Being tested
- Task-Oriented Rehabilitation, Traditional Physiotherapy Rehabilitation
- Keywords
- Task-Oriented Rehabilitation, Early Rehabilitation, Stroke Recovery, Neurorehabilitation, Physical Therapy, Motor Function, Ischemic Stroke, Hemorrhagic Stroke, Randomized Controlled Trial
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-Oriented RehabilitationBehavioural
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.
Traditional Physiotherapy RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Traditional Physiotherapy Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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..
Measured: Baseline (pre-intervention) At hospital discharge (Day 7-14 after admission) 3 months after hospital discharge
Secondary outcomes (2)
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.
Measured: Baseline (pre-intervention) At hospital discharge (Day 7-14 after admission) 3 months after hospital discharge
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.
Measured: Baseline (pre-intervention) At hospital discharge (Day 7-14 after admission) 3 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Asaad Fahmy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311304
- Sponsor's protocol ID
- Task-Oriented Rehabilitation
- Status last verified
- Dec 2025
- First submitted
- 27 Sep 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 26864411French 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 27841442Winstein 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 27145936Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
PubMed 21571152Page 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Efficacy of Early Task-Oriented Rehabilitation in Acute Stroke Recovery Compared to Traditional Rehabilitation
- ClinicalTrials.gov ID
- NCT07311304
- Acronym / sponsor ID
- Task-Oriented Rehabilitation
- Conditions
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
- Keywords
- Task-Oriented Rehabilitation, Early Rehabilitation, Stroke Recovery, Neurorehabilitation, Physical Therapy, Motor Function, Ischemic Stroke, Hemorrhagic Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Task-Oriented Rehabilitation | Experimental | Behavioral: Task-Oriented RehabilitationParticipants 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. |
| Active Comparator: Traditional Physiotherapy Rehabilitation | Active comparator | Behavioral: Traditional Physiotherapy RehabilitationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Task-Oriented RehabilitationA 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. | Behavioural | Experimental: Task-Oriented Rehabilitation |
| Traditional Physiotherapy RehabilitationStandard 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. | Behavioural | Active Comparator: Traditional Physiotherapy Rehabilitation |
Primary outcome
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..
2 secondary outcomes
Stroke Impact Scale (SIS)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Background: PubMed 26864411Winstein 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.
- Background: PubMed 27841442French 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.
- Background: PubMed 27145936Winstein 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.
- Background: PubMed 21571152Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
- Background: PubMed 15295770Page 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Task-Oriented Rehabilitation and Traditional Physiotherapy Rehabilitation in people with Stroke and Ischemic Stroke, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariam Asaad Fahmy, Principal Investigator (+201018198423, Mariam.17289868@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (FMA, Motor Domain) (time frame: Baseline (pre-intervention) At hospital discharge (Day 7-14 after admission) 3 months after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07311304, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.