StrokeSES-HandNCT06826976
Influence of Sensory Electrical Stimulation on Hand Functions in Chronic Stroke Patients
A study testing sensory electrical stimulation and task specific training program in people with Stroke and Hand Functionality, run by Cairo University at 1 site in Egypt.
Trial summary
This study investigates the impact of sensory electrical nerve stimulation (SENS) on hand function in chronic stroke patients. Thirty participants were randomly divided into two groups: Study Group (A): Received SENS combined with task-specific training. Control Group (B): Received only task-specific training. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke, Hand Functionality
- What is being tested?
- sensory electrical stimulation and task specific training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have experienced their first-ever ischemic stroke in the carotid system domain.
- Age range: 40 to 65 years old.
- Duration of illness: 30 to 180 days since stroke onset.
- Spasticity of the affected hand muscles (wrist flexors, finger flexors, and finger adductors) must be grade 1+ or less according to the Modified Ashworth Scale.
- Hand dysfunction severity ranges from mild to severe, defined by a score of ≤ 4 on the Medical Research Council Scale.
Who cannot join
- Presence of a deformity in the paralytic upper limb before the stroke.
- History of a lower motor neuron lesion in the impaired upper extremity (e.g., polyneuropathy) before the stroke.
- Skin abrasions or ulcerations on the affected upper limb.
- Unstable health conditions, including cardiac dysfunction, end-stage renal failure, unstable diabetes, or uncontrolled hypertension (>190/110).
- Presence of a pacemaker or other implanted electrically sensitive devices.
- Significant orthopedic conditions or chronic pain syndromes.
- Chronic use of medications that may influence motor or sensory excitability (e.g., anti-epileptic or antipsychotic drugs).
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study investigates the impact of sensory electrical nerve stimulation (SENS) on hand function in chronic stroke patients. Thirty participants were randomly divided into two groups:
Study Group (A): Received SENS combined with task-specific training.
Control Group (B): Received only task-specific training.
Assessments conducted before and after the intervention included measurements of grip strength, pinch strength, wrist range of motion, and performance on the Action Research Arm Test (ARAT).
Read the detailed description
This study explores the effectiveness of sensory electrical nerve stimulation (SENS) in enhancing hand function among chronic stroke patients. Thirty participants were randomly divided into two groups:
Study Group (A): Received SENS combined with task-specific training.
Control Group (B): Received only task-specific training.
Assessment Methods:
Before and after the intervention, both groups underwent evaluations using:
Grip Dynamometer: To measure grip strength.
Pinch Dynamometer: To assess pinch strength.
Digital Goniometer: To determine wrist flexion and extension range of motion.
Action Research Arm Test (ARAT): To evaluate upper limb functional performance.
- Conditions
- Stroke, Hand Functionality
- Being tested
- sensory electrical stimulation, task specific training program
- Keywords
- stroke, hand function, sensory electrical nerve stimulation, task specific training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensory electrical stimulationOther
peripheral sensory electrical stimulation on median, ulnar, and radial nerves of affected upper limb, simultaneously with Task Specific Training program which included four subtests of Action Research Arm Test scale.
task specific training programOther
received task specific training program only. Patients were tested pre and post treatment by Grip dynamometer, Pinch dynamometer, Digital goniometer and Action Research Arm Test Scale (ARAT).
| Study group | Role | What they receive |
|---|---|---|
| Sensory electrical stimulation | Experimental | received sensory electrical stimulation and task specific training program Receives: Other: sensory electrical stimulation |
| Task specific training | Active comparator | received task specific training program only. Patients were tested pre and post treatment by Grip dynamometer, Pinch dynamometer, Digital goniometer and Action Research Arm Test Scale (ARAT). Receives: Other: task specific training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
The patient seated with his/her shoulder adducted and naturally rotated, elbow flexed at 90 degrees, forearm in neutral position, and wrist between 0- and 30-degrees dorsiflexion and between 0- and 15-degrees ulnar deviation. The Jamar hand dynamometer was set to the second handle position from the inside. Lightly hold around the readout dial to prevent inadvertent dropping. After the patient was positioned properly, the following statement was used "Squeeze as hard as you can…. harder …. harder…. relax" (16). The scores of three successive trials were recorded for each tested hand. The average score of three trials was compared to the normative data on the other side, which is in pounds.
Measured: From enrollment to the end of treatment at end of 4th week
wrist range of motion
Goniometer was used to assess wrist flexion-extension.
Measured: From enrollment to the end of treatment at end of 4th week
pinch strength
Three types of pinches were typically evaluated because they are involved in accomplishing occupational tasks and activities efficiently. In Tip Pinch: The patient pinched the ends of the pinch meter between the tips of the thumb and index finger. The test was administered by first giving the patient instructions and a demonstration, "Ready? Pinch as hard as you can." The patient was urged on as he or she attempted to pinch. The average of three trials was recorded. In Lateral Pinch (Key Pinch): The patient pinched the meter between the pad of the thumb and the lateral surface of the index finger. In Palmar Pinch (Three-Jaw Chuck): The patient pinched the meter between the pad of the thumb and the pads of the index and middle fingers
Measured: From enrollment to the end of treatment at end of 4th week
hand functions
Patients who achieve a maximum score on the first (most difficult) item are credited with having scored 3 on all subsequent items on that scale. If the patient scores less than 3 on the first item, then the second item is assessed. This is the easiest item, and if patients score 0 then they are unlikely to achieve a score above 0 for the remainder of the items and are credited with a zero for the other items. The maximum score on ARTS is 57 points (possible range 0 to 57).
Measured: From enrollment to the end of treatment at end of 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion10 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- In the context of the study on sensory electrical nerve stimulation (SENS) for chronic stroke patients, a parallel assignment model was utilized. Participants were randomly divided into two groups: Study Group (A): Received SENS combined with task-specific training. Control Group (B): Received only task-specific training. This design facilitated a direct comparison between the two groups to assess the added benefit of incorporating SENS into the rehabilitation program.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Hassan Fayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826976
- Sponsor's protocol ID
- P.T. REC/012/005208
- Acronym
- SES-Hand
- Status last verified
- Mar 2025
- First submitted
- 2 Feb 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Sensory Electrical Stimulation on Hand Functions in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT06826976
- Acronym / sponsor ID
- SES-Hand / P.T. REC/012/005208
- Conditions
- Stroke, Hand Functionality
- Keywords
- stroke, hand function, sensory electrical nerve stimulation, task specific training
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 10 Jun 2025 (estimated)
- First posted
- 14 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 investigates the impact of sensory electrical nerve stimulation (SENS) on hand function in chronic stroke patients. Thirty participants were randomly divided into two groups:
Study Group (A): Received SENS combined with task-specific training.
Control Group (B): Received only task-specific training.
Assessments conducted before and after the intervention included measurements of grip strength, pinch strength, wrist range of motion, and performance on the Action Research Arm Test (ARAT).
Detailed description
This study explores the effectiveness of sensory electrical nerve stimulation (SENS) in enhancing hand function among chronic stroke patients. Thirty participants were randomly divided into two groups:
Study Group (A): Received SENS combined with task-specific training.
Control Group (B): Received only task-specific training.
Assessment Methods:
Before and after the intervention, both groups underwent evaluations using:
Grip Dynamometer: To measure grip strength.
Pinch Dynamometer: To assess pinch strength.
Digital Goniometer: To determine wrist flexion and extension range of motion.
Action Research Arm Test (ARAT): To evaluate upper limb functional performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the context of the study on sensory electrical nerve stimulation (SENS) for chronic stroke patients, a parallel assignment model was utilized. Participants were randomly divided into two groups: Study Group (A): Received SENS combined with task-specific training. Control Group (B): Received only task-specific training. This design facilitated a direct comparison between the two groups to assess the added benefit of incorporating SENS into the rehabilitation program.
| Arm | Type | Receives |
|---|---|---|
| Sensory electrical stimulation | Experimental | Other: sensory electrical stimulationreceived sensory electrical stimulation and task specific training program |
| Task specific training | Active comparator | Other: task specific training programreceived task specific training program only. Patients were tested pre and post treatment by Grip dynamometer, Pinch dynamometer, Digital goniometer and Action Research Arm Test Scale (ARAT). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have experienced their first-ever ischemic stroke in the carotid system domain.
- Age range: 40 to 65 years old.
- Duration of illness: 30 to 180 days since stroke onset.
- Spasticity of the affected hand muscles (wrist flexors, finger flexors, and finger adductors) must be grade 1+ or less according to the Modified Ashworth Scale.
- Hand dysfunction severity ranges from mild to severe, defined by a score of ≤ 4 on the Medical Research Council Scale.
Key exclusion criteria (8 listed)
- Presence of a deformity in the paralytic upper limb before the stroke.
- History of a lower motor neuron lesion in the impaired upper extremity (e.g., polyneuropathy) before the stroke.
- Skin abrasions or ulcerations on the affected upper limb.
- Unstable health conditions, including cardiac dysfunction, end-stage renal failure, unstable diabetes, or uncontrolled hypertension (>190/110).
- Presence of a pacemaker or other implanted electrically sensitive devices.
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 |
|---|---|---|
| sensory electrical stimulationperipheral sensory electrical stimulation on median, ulnar, and radial nerves of affected upper limb, simultaneously with Task Specific Training program which included four subtests of Action Research Arm Test scale. | Other | Sensory electrical stimulation |
| task specific training programreceived task specific training program only. Patients were tested pre and post treatment by Grip dynamometer, Pinch dynamometer, Digital goniometer and Action Research Arm Test Scale (ARAT). | Other | Task specific training |
Primary outcome
Hand grip strength
Time frame: From enrollment to the end of treatment at end of 4th week
The patient seated with his/her shoulder adducted and naturally rotated, elbow flexed at 90 degrees, forearm in neutral position, and wrist between 0- and 30-degrees dorsiflexion and between 0- and 15-degrees ulnar deviation. The Jamar hand dynamometer was set to the second handle position from the inside. Lightly hold around the readout dial to prevent inadvertent dropping. After the patient was positioned properly, the following statement was used "Squeeze as hard as you can…. harder …. harder…. relax" (16). The scores of three successive trials were recorded for each tested hand. The average score of three trials was compared to the normative data on the other side, which is in pounds.
wrist range of motion
Time frame: From enrollment to the end of treatment at end of 4th week
Goniometer was used to assess wrist flexion-extension.
pinch strength
Time frame: From enrollment to the end of treatment at end of 4th week
Three types of pinches were typically evaluated because they are involved in accomplishing occupational tasks and activities efficiently. In Tip Pinch: The patient pinched the ends of the pinch meter between the tips of the thumb and index finger. The test was administered by first giving the patient instructions and a demonstration, "Ready? Pinch as hard as you can." The patient was urged on as he or she attempted to pinch. The average of three trials was recorded. In Lateral Pinch (Key Pinch): The patient pinched the meter between the pad of the thumb and the lateral surface of the index finger. In Palmar Pinch (Three-Jaw Chuck): The patient pinched the meter between the pad of the thumb and the pads of the index and middle fingers
hand functions
Time frame: From enrollment to the end of treatment at end of 4th week
Patients who achieve a maximum score on the first (most difficult) item are credited with having scored 3 on all subsequent items on that scale. If the patient scores less than 3 on the first item, then the second item is assessed. This is the easiest item, and if patients score 0 then they are unlikely to achieve a score above 0 for the remainder of the items and are credited with a zero for the other items. The maximum score on ARTS is 57 points (possible range 0 to 57).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
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 sensory electrical stimulation and task specific training program in people with Stroke and Hand Functionality, run by Cairo 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 5 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 27 Mar 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?
This study is still under way. Results are not available in the source record yet.
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?
Hand grip strength (time frame: From enrollment to the end of treatment at end of 4th week). The study lists 4 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 27 Mar 2025.