Acute StrokeNCT07273201
Isolated Versus Synergetic Muscle Facilitation on Upper Limb Functional Performance in Acute Stroke
A study testing standard physical therapy program, isolated muscle facilitation and synergetic muscle facilitation program in people with Acute Stroke, run by Cairo University at 1 site in Egypt.
Trial summary
This study is a randomized controlled clinical trial that will be carried out to investigate the effect of isolated versus synergetic muscle facilitation on upper limb functional performance in patients with acute stroke. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- standard physical therapy program, isolated muscle facilitation and synergetic muscle facilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to Jul 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 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral Middle cerebral artery (MCA) stroke patients
- Brunnstrom stage of recovery 1\& 2
- Normal body mass index (18.5 - 24.99 kg/m2)
- Dominant handedness
Who cannot join
- Perceptual, apraxia, major cognitive deficits
- Recurrent stroke
- Subjects with cerebellar lesions, painful or subluxated shoulder, any contracture or deformity of the upper extremity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
faculty of Physical Therapy, Cairo University, and El kasr El-Einy hospitals
Cairo
Abeer Abo-Bakr Elwishy, professor
Ebtesam Mohamed fahmy, professor
About this study
Official title: Effect of Isolated Versus Synergetic Muscle Facilitation on Upper Limb Functional Performance in Patients With Acute Stroke
This study is a randomized controlled clinical trial that will be carried out to investigate the effect of isolated versus synergetic muscle facilitation on upper limb functional performance in patients with acute stroke.
RESEARCH QUESTION:
Read more
Is there a difference between isolated and synergetic muscle facilitation on upper limb functional performance in patients with acute stroke?
It will be hypothesized that:
There will be no difference between isolated and synergetic muscle facilitation on upper limb task-oriented training in patients with acute stroke.
Treatment procedures:
Study group (A): patients will receive a physical therapy program in the form of a range of motion exercise, electrical muscle stimulation, stretching exercise, mental practice with motor imagery, and isolated muscle facilitation using electromyography (EMG) biofeedback for six weeks and followed by task-oriented training of the upper limb for six weeks control group (B): will receive a standard physical therapy program including range of motion exercise, electrical muscle stimulation, Mental practice with motor imagery and stretching exercise, synergetic muscle facilitation for six weeks, and followed by task-oriented training of the upper limb for six weeks.
- Conditions
- Acute Stroke
- Being tested
- standard physical therapy program, isolated muscle facilitation, synergetic muscle facilitation program
- Keywords
- acute stroke, upper limb functional performance, muscle facilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard physical therapy programOther
- Soft tissue technique (stretch) will be applied for the anterior pectoral region, elbow flexors, pronators, wrist flexors, and finger flexors(for both research groups.
- Passive Range of motion exercises will be applied for the glenohumeral joint, scapulothoracic articulation, elbow joint, radioulnar joint, and wrist joint(for both research groups).
- Muscular electrical stimulation will be applied for supraspinatus, anterior and posterior deltoid, biceps and triceps, pronators and supinators, wrist and finger extensors, and finally the lumbricals (Each muscle group 20 min) (for both research groups).
In mental practice, the patient adheres to a set of imagined task performances ( picking up a cup) or movements (reaching out with the arm).
isolated muscle facilitationOther
Muscle facilitation exercises will be applied for the anterior deltoid, middle deltoid, posterior deltoid, biceps, triceps, radioulnar pronators and supinators, wrist and finger extensors, wrist and finger flexors, and lumbricals using EMG biofeedback.
During EMG biofeedback training, the electrodes will be placed on (pectoralis major, triceps, and finger flexor muscles, and (trapezius, biceps, and wrist flexors) to ensure the isolated firing of each muscle group (100 reps each muscle group). Before training, patients should be instructed how to perform muscle contraction exercises according to the displayed EMG signal through multimedia publicity, to improve their coordination. During training, patients can take a sitting or lying down position. Then, the electrode piece will be attached to the abdominal part of the patients' deltoid muscle, triceps brachii, a forearm muscle group, thus collecting the EMG signal generated by the relaxation of the patients' upper limb muscles
synergetic muscle facilitation programOther
Muscle facilitation exercises will be applied for the anterior deltoid, middle deltoid, posterior deltoid, biceps, triceps, radioulnar pronators and supinators, wrist and finger extensors, wrist and finger flexors, and lumbricals During the synergetic muscle facilitation, we will permit the muscles that are linked together through flexion or extension synergy to fire together (100 reps each muscle group) using EMG biofeedback training.
| Study group | Role | What they receive |
|---|---|---|
| isolated muscle facilitation training | Experimental | Participants in this group will receive a standard physical therapy program including range of motion exercise, electrical muscle stimulation, and Mental practice with motor imagery and stretching exercise, isolated muscle facilitation using electromyography (EMG) biofeedback for six weeks, followed by task-oriented training ofthe upper limb for six weeks Receives: Other: standard physical therapy program; Other: isolated muscle facilitation |
| synergistic muscle facilitation training | Active comparator | Participants in this group will receive a standard physical therapy program, including a range of motion exercise, electrical muscle stimulation, Mental practice with motor imagery, and stretching exercise, synergetic muscle facilitation for six weeks, and followed by task-oriented training of the upper limb for six weeks Receives: Other: standard physical therapy program; Other: synergetic muscle facilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of upper limb functional performance (dexterity- coordination) using the Action Reach Arm Test (ARAT)
- Action Reach Arm Test (ARAT): It will be used to assess upper extremity performance (coordination, dexterity, and functioning). It is a 19-item observational measure. Items are categorized into four subscales (grasp, grip, pinch, and gross movement) and arranged in order of decreasing difficulty. Subjects are first asked to perform the most difficult task within a subscale, followed by the least difficult task. while scoring the individual based on their performance of each task
-Required Equipment: Chair without armrests, Table, Wooden blocks of various sizes, Cricket ball, Sharpening stone, Alloy tubes, Washer and bolt, 2 glasses Sharpening stone, Marbles, Ball bearings, and a Tin lid.
-scoring: Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Scores on the ARAT may range from 0 to 57 points, with a maximum score of 57 indicating better performance.
Measured: before enrollment and the end of treatment at 6 weeks
Secondary outcomes (1)
Analysis of upper limb kinematics (shoulder, elbow, and wrist Positions and acceleration speed of movement) using Kinovea software
Kinovea is a valid, precise, and reliable computer program for measuring angles and distances. Kinovia software will be used to analyze the kinematics (Position and acceleration speed)of the shoulder, elbow, and wrist. while patients perform the subscales of the Action Reach Arm Test.
- Instrumentation: Digital video camera and Computer equipment for the measurement process.
- procedure: All participants were instructed to wear light clothes for the determination of the selected bony landmarks and to allow easy forward reaching motion. An adhesive marker dot will be placed on preselected anatomical landmarks like the acromion, lateral epicondyle, and wrist (ulnar styloid/mid-forearm) to measure joint angles (shoulder, elbow, wrist) and movement speed. Then, patients will be asked to perform the subscales of the Action Reach Arm Test, such as reaching and grasping. Patients will be captured while performing these tasks using video camera and will be analyzed using Kinovia program.
Measured: Before enrollment and at the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Oct 2025
- Primary completionApr 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mohamed Mousa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273201
- Sponsor's protocol ID
- P.T.REC/012/005625
- Status last verified
- Dec 2025
- First submitted
- 15 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Isolated Versus Synergetic Muscle Facilitation on Upper Limb Functional Performance in Patients With Acute Stroke
- ClinicalTrials.gov ID
- NCT07273201
- Acronym / sponsor ID
- P.T.REC/012/005625
- Conditions
- Acute Stroke
- Keywords
- acute stroke, upper limb functional performance, muscle facilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 9 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.
This study is a randomized controlled clinical trial that will be carried out to investigate the effect of isolated versus synergetic muscle facilitation on upper limb functional performance in patients with acute stroke.
RESEARCH QUESTION:
Is there a difference between isolated and synergetic muscle facilitation on upper limb functional performance in patients with acute stroke?
It will be hypothesized that:
There will be no difference between isolated and synergetic muscle facilitation on upper limb task-oriented training in patients with acute stroke.
Treatment procedures:
Study group (A): patients will receive a physical therapy program in the form of a range of motion exercise, electrical muscle stimulation, stretching exercise, mental practice with motor imagery, and isolated muscle facilitation using electromyography (EMG) biofeedback for six weeks and followed by task-oriented training of the upper limb for six weeks control group (B): will receive a standard physical therapy program including range of motion exercise, electrical muscle stimulation, Mental practice with motor imagery and stretching exercise, synergetic muscle facilitation for six weeks, and followed by task-oriented training of the upper limb for six weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isolated muscle facilitation training | Experimental | Other: standard physical therapy program, Other: isolated muscle facilitationParticipants in this group will receive a standard physical therapy program including range of motion exercise, electrical muscle stimulation, and Mental practice with motor imagery and stretching exercise, isolated muscle facilitation using electromyography (EMG) biofeedback for six weeks, followed by task-oriented training ofthe upper limb for six weeks |
| synergistic muscle facilitation training | Active comparator | Other: standard physical therapy program, Other: synergetic muscle facilitation programParticipants in this group will receive a standard physical therapy program, including a range of motion exercise, electrical muscle stimulation, Mental practice with motor imagery, and stretching exercise, synergetic muscle facilitation for six weeks, and followed by task-oriented training of the upper limb for six weeks |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Unilateral Middle cerebral artery (MCA) stroke patients
- Brunnstrom stage of recovery 1\& 2
- Normal body mass index (18.5 - 24.99 kg/m2)
- Dominant handedness
Key exclusion criteria (3 listed)
- Perceptual, apraxia, major cognitive deficits
- Recurrent stroke
- Subjects with cerebellar lesions, painful or subluxated shoulder, any contracture or deformity of the upper extremity
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 |
|---|---|---|
| standard physical therapy program* Soft tissue technique (stretch) will be applied for the anterior pectoral region, elbow flexors, pronators, wrist flexors, and finger flexors(for both research groups. * Passive Range of motion exercises will be applied for the glenohumeral joint, scapulothoracic articulation, elbow joint, radioulnar joint, and wrist joint(for both research groups). * Muscular electrical stimulation will be applied for supraspinatus, anterior and posterior deltoid, biceps and triceps, pronators and supinators, wrist and finger extensors, and finally the lumbricals (Each muscle group 20 min) (for both research groups). In mental practice, the patient adheres to a set of imagined task performances ( picking up a cup) or movements (reaching out with the arm). | Other | isolated muscle facilitation training, synergistic muscle facilitation training |
| isolated muscle facilitationMuscle facilitation exercises will be applied for the anterior deltoid, middle deltoid, posterior deltoid, biceps, triceps, radioulnar pronators and supinators, wrist and finger extensors, wrist and finger flexors, and lumbricals using EMG biofeedback. During EMG biofeedback training, the electrodes will be placed on (pectoralis major, triceps, and finger flexor muscles, and (trapezius, biceps, and wrist flexors) to ensure the isolated firing of each muscle group (100 reps each muscle group). Before training, patients should be instructed how to perform muscle contraction exercises according to the displayed EMG signal through multimedia publicity, to improve their coordination. During training, patients can take a sitting or lying down position. Then, the electrode piece will be attached to the abdominal part of the patients' deltoid muscle, triceps brachii, a forearm muscle group, thus collecting the EMG signal generated by the relaxation of the patients' upper limb muscles | Other | isolated muscle facilitation training |
| synergetic muscle facilitation programMuscle facilitation exercises will be applied for the anterior deltoid, middle deltoid, posterior deltoid, biceps, triceps, radioulnar pronators and supinators, wrist and finger extensors, wrist and finger flexors, and lumbricals During the synergetic muscle facilitation, we will permit the muscles that are linked together through flexion or extension synergy to fire together (100 reps each muscle group) using EMG biofeedback training. | Other | synergistic muscle facilitation training |
Primary outcome
Evaluation of upper limb functional performance (dexterity- coordination) using the Action Reach Arm Test (ARAT)
Time frame: before enrollment and the end of treatment at 6 weeks
- Action Reach Arm Test (ARAT): It will be used to assess upper extremity performance (coordination, dexterity, and functioning). It is a 19-item observational measure. Items are categorized into four subscales (grasp, grip, pinch, and gross movement) and arranged in order of decreasing difficulty. Subjects are first asked to perform the most difficult task within a subscale, followed by the least difficult task. while scoring the individual based on their performance of each task -Required Equipment: Chair without armrests, Table, Wooden blocks of various sizes, Cricket ball, Sharpening stone, Alloy tubes, Washer and bolt, 2 glasses Sharpening stone, Marbles, Ball bearings, and a Tin lid. -scoring: Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Scores on the ARAT may range from 0 to 57 points, with a maximum score of 57 indicating better performance.
1 secondary outcome
Analysis of upper limb kinematics (shoulder, elbow, and wrist Positions and acceleration speed of movement) using Kinovea software
Time frame: Before enrollment and at the end of treatment at 6 weeks
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 9 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard physical therapy program, isolated muscle facilitation and synergetic muscle facilitation program in people with Acute Stroke, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Mohamed A Mousa, assistant lecturer (+20 10 92841554, Mohamed.Mousa@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of upper limb functional performance (dexterity- coordination) using the Action Reach Arm Test (ARAT) (time frame: before enrollment and the end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2025.