Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202505804979619 Date of Approval: 19/05/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Influence of task-oriented mirror therapy on motor recovery and functional outcome in post-stroke upper limb dysfunction.
Official scientific title Influence of task-oriented mirror therapy on motor recovery and functional outcome in post-stroke upper limb dysfunction.
Brief summary describing the background and objectives of the trial Neural plasticity, or the brain’s capacity to reorganize itself by forming new neural connections, is crucial for recovery after stroke. Research has demonstrated that targeted rehabilitation therapies can stimulate the brain’s ability to form these new connections, enhancing motor recovery. However, selected rehabilitation techniques may not fully exploit the potential for neuroplasticity, particularly in severe cases of upper limb dysfunction. This has led to growing interest in innovative approaches like task-oriented mirror therapy. Neuroplasticity, the brain's remarkable ability to reorganize itself by forming new neural connections, is a cornerstone of recovery after stroke. Targeted rehabilitation therapies can stimulate this process, enhancing motor recovery. However, selected rehabilitation techniques may not fully harness the potential of neuroplasticity, particularly in cases of severe upper limb dysfunction. This has led to a growing interest in innovative approaches like task-oriented mirror therapy (TMT). TMT builds on the principles of visual feedback and motor learning. It involves using a mirror to reflect the movements of the unaffected limb, creating the illusion that the affected limb is also moving. This technique has been shown to engage brain areas responsible for motor control, thereby promoting neural reorganization. Therefore, incorporating task-specific movements, mirror therapy may more effectively engage the motor pathways involved in functional recovery. This study aims to investigate the impact of TMT on upper limb motor function, cortical plasticity, and quality of life in individuals with chronic stroke. By systematically examining the effects of TMT on brain activation patterns and behavioral outcomes, this research will contribute to a deeper understanding of the underlying neural mechanisms.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 25/05/2025
Actual trial start date
Anticipated date of last follow up 15/10/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Task oriented mirror therapy group A Three times per week for 60 minutes. 12 weeks Task-oriented Mirror Therapy and selected physical therapy (30 minutes for Task-oriented mirror Therapy and 30 minutes for selected Physical Therapy): Task-oriented Mirror Therapy: Mirror therapy will involve movements such as grasping, reaching, and manipulating objects using the unaffected arm, with visual feedback provided through a mirror. Therapy sessions will be held 3 times per week for 60 minutes, over a period of 12 weeks. 20
Control Group Selected physical therapy program group B Three times per week for 60 minutes. 12 weeks Participants in the control group will receive selected physical therapy, which includes passive range of motion exercises, task-specific training, and strength exercises. Resistance Bands: Used for resistance training exercises aimed at improving wrist, forearm, and hand muscle strength. Dumbbells Lightweight (0.5-1 kg): Used for wrist and arm strength training during therapy sessions, focusing on controlled motion in various planes. Therapy Ball (Squeeze Ball) 7-10 cm diameter, soft gel or foam: Enhances fine motor skills and strengthens hand muscles through repetitive gripping and releasing exercises. Therapy sessions will be held 3 times per week for 60 minutes over a period of 12 weeks. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All participants will be chosen under the following criteria: -Adults both sexes, aged 45-60 years. -Individuals who have experienced a unilateral ischemic stroke more than 6 months prior to study enrolment -Participants with mild to moderate upper limb motor impairment, as assessed by the Fugl-Meyer Assessment Scale -Individuals with stable medical conditions that allow for regular physical therapy participation Patients will be excluded from the study if they met any of the following criteria. -Participants with significant cognitive impairment -Individuals with pre-existing upper limb disabilities unrelated to stroke -Patients with contraindications for magnetic brain stimulation (e.g., implanted metal devices, seizure disorders). Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/02/2025 Ethical committee office at Faculty of Physical Therapy at Cairo uni.
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El-Zayat Street, Dokki Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Neural Plasticity will be assessed using Motor Evoked Potentials (MEP) recorded using Transcranial Magnetic Stimulation (TMS). it will be employed to measure cortical excitability and neuroplastic changes in the motor cortex. MEPs provide direct insight into the functionality of the corticospinal tract, helping to elucidate the underlying neural mechanisms driving motor recovery in stroke survivors. Pre intervention and after intervention by 6 weeks and 12 weeks, Three times
Secondary Outcome Upper limb functional recovery will be assessed by Wolf Motor Function Test (WMFT) It focuses on timed tasks, measuring the speed and skill with which patients’ complete movements that are essential for daily living activities, making it highly relevant for assessing upper extremity functional recovery Pre intervention and after intervention by 6 weeks and 12 weeks, Three times
Secondary Outcome Motor recover of upper limb using Fugl-Meyer Assessment for Upper Extremity (FMA-UE) The FMA-UE is a comprehensive and validated tool used to assess motor recovery post-stroke. It evaluates several domains, including motor performance, balance, sensation, and joint functioning. Pre intervention and after intervention by 6 weeks and 12 weeks, Three times
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinics at the faculty of physical therapy at cairo university 7 Ahmed El-Zayat Street, Dokki Giza 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Physical Therapy at Cairo uni. 7 Ahmed El-Zayat St. Giza 12613 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy at Cairo uni. 7 Ahmed El-Zayat St. Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rania Mamdouh Mokhtar Ahmed ronosh.ahmed995@gmail.com 00201128809620 7 Ahmed El-Zayat St., Dokki
City Postal code Country Position/Affiliation
Giza 12613 Egypt Physiotherapist at the Egyptian Ministry of Health
Role Name Email Phone Street address
Scientific Enquiries Hoda Mohamed Zakaria Dr_hodazakria@yahoo.com 00201013107750 7 Ahmed El-Zayat St., Dokki
City Postal code Country Position/Affiliation
Giza 12613 Egypt Professor of Physical Therapy for Neurology and Neurosurgery Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Ebtesam Mohamed Fahmy em_fahmy@kasralainy.edu.eg 00201002007077 7 Handosa St. Al kasr Al ainy St.
City Postal code Country Position/Affiliation
Giza 11562 Egypt Professor Department Of Neurology Faculty of Medicine Faculty of Medicine Al Kasr Al Ainy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Shereen Ibrahim Taha shreen_taha@pt.bsu.edu.eg 00201016167521 Salah Salem St.
City Postal code Country Position/Affiliation
Beni Suef 62521 Egypt Assistant professor Physical Therapy for neurology and neurosurgery Faculty of Physical Therapy Beni Suef University
Role Name Email Phone Street address
Scientific Enquiries Moustafa mahmoud Elkholy mostafaelkholy@med.bsu.edu.eg 00201100103296 Salah Salem St.
City Postal code Country Position/Affiliation
Beni Suef 62521 Egypt Assistant professor Neurophysiology department Faculty of medicine Beni Suef University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of Individual Participant Data (IPD) collected during the trial, after deidentification will be shared for research purposes only. Informed Consent Form Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Only Researchers in the project can see the data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information