Chronic Stroke SurvivorsNCT06836596
Efficacy of Sensory Electrical Stimulation Versus Alternating Electromyogram (EMG) On Functional Recovery Of Hand in Chronic Stroke Survivors :Randomized Controlled Trial
A study testing Peripheral sensory electrical stimulation via Elettronica Pagani Roland series model: ET 20 S/N: 1907 (Made in Italy) and Alternating electromyogram (EMG) neuromuscular electrical stimulation via MyoTrac Infiniti device (T9800, Thought Technology Ltd. Montreal, Quebec, Canada) in people with Chronic Stroke Survivors and Chronic Stroke Survivors With Plegic Hand, run by Suez University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Chronic Stroke Survivors, Chronic Stroke Survivors With Plegic Hand
- What is being tested?
- Peripheral sensory electrical stimulation via Elettronica Pagani Roland series model: ET 20 S/N: 1907 (Made in Italy) and Alternating electromyogram (EMG) neuromuscular electrical stimulation via MyoTrac Infiniti device (T9800, Thought Technology Ltd. Montreal, Quebec, Canada)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 7 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Peripheral sensory electrical stimulation via Elettronica Pagani Roland series model: ET 20 S/N: 1907 (Made in Italy), Alternating electromyogram (EMG) neuromuscular electrical stimulation via MyoTrac Infiniti device (T9800, Thought Technology Ltd. Montreal, Quebec, Canada)
- Keywords
- Sensory Electrical Stimulation - Alternating Electromyogram (EMG) - Functional Recovery - Hand - Chronic Stroke Survivors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral sensory electrical stimulation via Elettronica Pagani Roland series model: ET 20 S/N: 1907 (Made in Italy)Device
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
Alternating electromyogram (EMG) neuromuscular electrical stimulation via MyoTrac Infiniti device (T9800, Thought Technology Ltd. Montreal, Quebec, Canada)Device
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
| Study group | Role | What they receive |
|---|---|---|
| Group A (Sensory Electrical Stimulation Group) | Experimental | 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. Receives: Device: Peripheral sensory electrical stimulation via Elettronica Pagani Roland series model: ET 20 S/N: 1907 (Made in Italy) |
| Group B (Alternating EMG Stimulation Group) | Active comparator | 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. Receives: Device: Alternating electromyogram (EMG) neuromuscular electrical stimulation via MyoTrac Infiniti device (T9800, Thought Technology Ltd. Montreal, Quebec, Canada) |
| Group C (Control Group) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test (ARAT)
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.
Measured: 12 weeks
modified Ashworth scale
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.
Measured: 12 weeks
Medical Research Council scale for Fingers and Wrist
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Dec 2023
- Primary completion7 Dec 2024
- Study completion7 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stroke SurvivorsStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dany Alphonse Anwar Habib, Suez University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836596
- Sponsor's protocol ID
- P.T.REC/012/004916
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sensory Electrical Stimulation Versus Alternating Electromyogram (EMG) On Functional Recovery Of Hand in Chronic Stroke Survivors :Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06836596
- Acronym / sponsor ID
- P.T.REC/012/004916
- Keywords
- Sensory Electrical Stimulation - Alternating Electromyogram (EMG) - Functional Recovery - Hand - Chronic Stroke Survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Suez UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 7 Dec 2024 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 20 Feb 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Sensory Electrical Stimulation Group) | Experimental | Device: Peripheral sensory electrical stimulation via Elettronica Pagani Roland series model: ET 20 S/N: 1907 (Made in Italy)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. |
| Group B (Alternating EMG Stimulation Group) | Active comparator | Device: Alternating electromyogram (EMG) neuromuscular electrical stimulation via MyoTrac Infiniti device (T9800, Thought Technology Ltd. Montreal, Quebec, Canada)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. |
| Group C (Control Group) | No intervention | –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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| 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 | Device | Group A (Sensory Electrical Stimulation Group) |
| 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 | Device | Group B (Alternating EMG Stimulation Group) |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No. 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
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral sensory electrical stimulation via Elettronica Pagani Roland series model: ET 20 S/N: 1907 (Made in Italy) and Alternating electromyogram (EMG) neuromuscular electrical stimulation via MyoTrac Infiniti device (T9800, Thought Technology Ltd. Montreal, Quebec, Canada) in people with Chronic Stroke Survivors and Chronic Stroke Survivors With Plegic Hand, run by Suez 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (ARAT) (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 20 Feb 2025.