Efficacy of Sensory Electrical Stimulation Versus Alternating Electromyogram (EMG) On Functional Recovery Of Hand in Chronic Stroke Survivors :Randomized Controlled Trial

February 15, 2025 updated by: Dany Alphonse Anwar Habib, Suez University
This study aims to find out which treatment works better for improving hand function in stroke patients: sensory electrical stimulation or alternating electromyogram (EMG) stimulation. Both methods use electrical stimulation to help patients regain hand movement, but they work in slightly different ways. The goal is to see if one method is more effective than the other in helping stroke survivors recover their hand abilities.

Study Overview

Status

Status

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

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 (Actual)

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.
60

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 Locations

  • Egypt
      • Giza, Egypt
        • Faculty of physical therapy, Cairo universuty

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Chronic stroke patients were between 45 and 65 years old, with a duration of illness ranging from 6 to 18 months post-stroke. They exhibited upper extremity spasticity no greater than 1+ on the Modified Ashworth Scale. Patients were cooperative, as indicated by a Mini-Mental State Examination (MMSE) score of ≥ 24, and were capable of grasping and releasing at least one block in the Box and Block Test.

Exclusion Criteria:

  • Hand function impairment caused by factors other than stroke, unstable health conditions such as cardiac dysfunction, end-stage renal failure, or uncontrolled diabetes, long-term use of medications that may affect motor or sensory excitability, contractures or restrictions in wrist joint range of motion, pre-existing musculoskeletal diseases significantly impacting physical function, and a history of Botulinum Toxin injection in the hand muscles.

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: None (Open Label)

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: Group A (Sensory Electrical Stimulation Group)
This group receives the active treatment of peripheral sensory electrical stimulation along with the hand function training program, making it the experimental group being tested for its effects on improving hand function in stroke patients.
Device: Peripheral sensory electrical stimulation via Elettronica Pagani Roland series model: ET 20 S/N: 1907 (Made in Italy)
Sensory electrical stimulation, Transcutaneous electrical nerve stimulation (TENS) involves delivering electrical current through electrodes placed on the skin to manage pain. It can be applied at different frequencies, ranging from low (50 Hz). The intensity can be adjusted from sensory to motor levels. Sensory intensity is when the patient experiences a strong yet comfortable sensation without triggering muscle contraction
Active Comparator: Group B (Alternating EMG Stimulation Group)
This is because this group is receiving a different active treatment (alternating EMG stimulation) along with hand function training, and it is being compared to the other active treatment (sensory electrical stimulation) in Group A. Both groups are experimental, but Group B serves as a comparison to Group A in the study.
Device: Alternating electromyogram (EMG) neuromuscular electrical stimulation via MyoTrac Infiniti device (T9800, Thought Technology Ltd. Montreal, Quebec, Canada)
the device detects the EMG threshold value (peak muscle torque) of the target muscle and activates stimulation to enhance the patient's voluntary activation of the targeted muscle groups. It is used to assess peak muscle torque and deliver alternating and EMG-triggered stimulation. Surface electrodes are employed to detect electromyography in the affected muscle and administer electrical stimulation to the targeted muscle during treatment. The device stimulates the targeted muscles, after which the patient attempts to replicate the same movement until reaching the preset EMG feedback level
No Intervention: Group C (Control Group)
Group C only receives the designed hand function training program and does not receive any form of electrical stimulation, the electrodes are used, but no active stimulation is delivered. It serves as the control group for comparison against the experimental treatments in Groups A and B.

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
Action Research Arm Test (ARAT)
Time Frame: 12 weeks
assessment tool to evaluate the hand and arm function in individuals with stroke. It is often used to measure improvements in motor function, particularly for tasks like grasping, gripping, and other fine motor skills. It consists of 19 items assessing different aspects of arm and hand function, including tasks like reaching, grasping, and lifting objects. These tasks are scored, and the total score reflects the level of motor recovery and functional ability.
12 weeks
modified Ashworth scale
Time Frame: 12 weeks

is a widely used tool to assess spasticity, or increased muscle tone, in individuals with neurological conditions like stroke. It measures the resistance of a muscle to passive movement and helps evaluate the degree of spasticity in the affected limbs. MAS Scoring (for elbow, wrist, and shoulder): 0: No increase in muscle tone. 1: Slight increase in muscle tone, manifested by a catch and release or minimal resistance at the end of the range of motion.

1+: Slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout the remainder of the range of motion.

2: More marked increase in muscle tone through most of the range of motion, but the affected part(s) can still be easily moved.

3: Considerable increase in muscle tone, making passive movement difficult. 4: Affected part(s) rigid in flexion or extension.
12 weeks
Medical Research Council scale for Fingers and Wrist
Time Frame: 12 weeks

The Medical Research Council (MRC) Scale is a widely used method to assess muscle strength in different muscle groups, and to evaluate the strength of the fingers and wrist in stroke patients as part of this study.

The MRC Scale is a 6-point grading system used to measure muscle strength. Grade 0: No contraction - There is no visible or palpable muscle contraction. Grade 1: Trace contraction - A slight contraction can be felt, but no movement occurs.

Grade 2: Active movement, but not against gravity - The muscle can move the joint, but not against gravity.

Grade 3: Active movement against gravity - The muscle can move the joint against gravity but not against resistance.

Grade 4: Active movement against some resistance - The muscle can move the joint against resistance but is weaker than normal strength.

Grade 5: Normal strength - The muscle can move the joint against full resistance with no weakness.
12 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.
Suez 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.
December 1, 2023

Primary Completion (Actual)

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.
December 7, 2024

Study Completion (Actual)

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.
February 7, 2025

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).
February 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.
February 15, 2025

First Posted (Actual)

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.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

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.
March 25, 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.
February 15, 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.
February 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/012/004916

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

because they are Potential for Misuse. I am concerned about the misuse of IPD, where the data could be used to advance conflicting interests, such as in studies that are biased toward certain results or that could be manipulated to serve commercial purposes

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.

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