- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07273201
Isolated Versus Synergetic Muscle Facilitation on Upper Limb Functional Performance in Acute Stroke
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
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohamed A Mousa, assistant lecturer
- Phone Number: +20 10 92841554
- Email: Mohamed.Mousa@pt.cu.edu.eg
Study Locations
-
-
-
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
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
In mental practice, the patient adheres to a set of imagined task performances ( picking up a cup) or movements (reaching out with the arm). 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
|
In mental practice, the patient adheres to a set of imagined task performances ( picking up a cup) or movements (reaching out with the arm).
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
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
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.
|
Before enrollment and at the end of treatment at 6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005625
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
University Hospital HeidelbergCompletedAcute Ischemic Stroke | Acute Ischemic Stroke AIS | Acute Ischemic Stroke PatientsGermany
-
Capital Medical UniversityCompletedAcute Ischaemic Stroke | Stroke-associated PneumoniaChina
-
University of CalgaryThe George Institute for Global Health, AustraliaRecruitingAcute Ischemic Stroke AIS | Stroke, Acute, Stroke Ischemic | Stroke AcuteCanada, Australia
-
Chinese University of Hong KongThe Hong Kong Polytechnic University; City University of Hong Kong; Hong Kong... and other collaboratorsRecruitingAcute Ischemic Stroke | Acute Stroke | Acute Stroke InterventionHong Kong
-
Prof. Dr. Jan LimanUniversity Hospital, Basel, Switzerland; Klinikum Nürnberg; Deutsche ForschungegemeinschaftRecruitingHemorrhagic Stroke, Intracerebral | Acute Ischemic Stroke AIS | Stroke AcuteSwitzerland, Germany
-
University of MiamiNo longer availableStroke, Ischemic | Stroke, Acute | Mesenchymal Stem Cells | Acute Ischemic Stroke | Stroke/Brain AttackUnited States
-
Cidat, S.A. de C.V.El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezUnknownStroke | Stroke, Acute | Cerebral Stroke | Cerebrovascular Stroke | Cerebrovascular Accident, AcuteMexico
-
Hospital Universitari Vall d'Hebron Research InstituteMethinks Software SLRecruitingStroke | Ischemic Stroke, Acute | Thrombectomy | Stroke AcuteSpain
-
NeurotechnikaSamara State Medical University; Samara Regional Clinical Hospital V.D. SeredavinRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Acute | Stroke, Acute, Ischemic | Stroke with HemiparesisRussian Federation
-
Southwest Hospital, ChinaRecruitingAcute Ischemic Stroke PatientsChina
Clinical Trials on standard physical therapy program
-
Swiss Group for Clinical Cancer ResearchTerminatedMetastatic Colorectal CancerSwitzerland, Austria
-
Lawson Health Research InstituteCompleted
-
University of HailCompletedCerebral PalsySaudi Arabia
-
University of Kansas Medical CenterUnknown
-
Universitaire Ziekenhuizen KU LeuvenFund for Scientific Research, Flanders, BelgiumCompletedPain | Breast NeoplasmBelgium
-
Cairo UniversityRecruitingBurns | Muscle Weakness | Functional Performance | ExercisesEgypt
-
Riphah International UniversityCompleted
-
Riphah International UniversityCompletedCraniomandibular DysfunctionPakistan
-
Cairo UniversityNot yet recruitingPrimary DysmenorrheaEgypt