NCT07273201

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Oct 2025Jul 2026

Study Start

First participant enrolled

October 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

November 15, 2025

Last Update Submit

December 7, 2025

Conditions

Keywords

acute stroke, upper limb functional performance, muscle facilitation

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Before enrollment and at the end of treatment at 6 weeks

Study Arms (2)

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

Other: standard physical therapy programOther: 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

Other: standard physical therapy programOther: synergetic muscle facilitation program

Interventions

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.

synergistic muscle facilitation training

* 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 facilitation trainingsynergistic muscle facilitation training

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

isolated muscle facilitation training

Eligibility Criteria

Age50 Years - 60 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of Physical Therapy, Cairo University, and El kasr El-Einy hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Mohamed A Mousa, assistant lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of physical therapy for neurology and neurosurgery

Study Record Dates

First Submitted

November 15, 2025

First Posted

December 9, 2025

Study Start

October 1, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

December 9, 2025

Record last verified: 2025-12

Locations