Isolated Versus Synergetic Muscle Facilitation on Upper Limb Functional Performance in Acute Stroke

December 7, 2025 updated by: Mohamed Ahmed Mohamed Mousa, Cairo University

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:

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • faculty of Physical Therapy, Cairo University, and El kasr El-Einy hospitals
        • Principal Investigator:
          • Abeer Abo-Bakr Elwishy, professor
        • Principal Investigator:
          • Ebtesam Mohamed fahmy, professor
        • Sub-Investigator:
          • Shaimaa mohamed Abd Elmageed, assistant professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Perceptual, apraxia, major cognitive deficits
  • Recurrent stroke
  • Subjects with cerebellar lesions, painful or subluxated shoulder, any contracture or deformity of the upper extremity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: isolated muscle facilitation training
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
Other: 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

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
Active Comparator: synergistic muscle facilitation training
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
Other: 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: synergetic muscle facilitation program
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
before enrollment and the end of treatment at 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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

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.
Before enrollment and at the end of treatment at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/005625

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Stroke

Clinical Trials on standard physical therapy program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings