StrokeNCT07531381
Effect of Neuromuscular Electrical Stimulation With Task Oriented Training on Upper Extremity Function in Stroke Patients
A study testing Neuromuscular electrical stimulation, Task-oriented training and Designed physical therapy program in people with Stroke, run by Cairo University at 1 site in Egypt.
Trial summary
The current study aims to determine the effect of neuromuscular electrical stimulation combined with task-oriented training on upper limb function in patients with stroke. Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Neuromuscular electrical stimulation, Task-oriented training and Designed physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2025to 31 Mar 2026
- 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 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Forty-five stroke patients both genders (male and female)
- Patients Diagnosed with first-time ischemic/hemorrhagic stroke by their treating neurologists and confirmed by MRI scan.
- Middle cerebral artery stroke patient.
- Their ages range from 55-65 years.
- All patients were reported medically stable by their neurologist with a stroke incidence range between 6 and 24 months.
- The affected UE scored [1+\&2] on the modified Ashworth scale (MAS).
- Patients had normal sensation of the affected UE, as measured by the Nottingham Sensory Assessment (NSA) scale (score 2 for tactile sensation and kinesthesia and score 3 for (stereognosis).
Who cannot join
- Other neurological disorders that cause motor deficits, such as Parkinson's disease, peripheral neuropathy, and diabetes mellitus.
- Severe aphasia, resulting in communication difficulties that could influence the intervention and outcome measures.
- Cognitive impairment resulting in cooperation difficulties (a score of ≤24 in the Mini-Mental State Examination).
- Severe pain impeding upper extremity rehabilitation (Numeric Pain Rating Scale score ≥7).
- Significant visual dysfunction.
- severe spasticity (contracture).
Trial locations and contacts
1 site in 1 country.
About this study
The current study aims to determine the effect of neuromuscular electrical stimulation combined with task-oriented training on upper limb function in patients with stroke.
Read the detailed description
Upper limb dysfunction following stroke is a major cause of disability, limiting independence in daily activities and reducing quality of life. Improving upper limb function is therefore a primary goal in stroke rehabilitation.
Neuromuscular electrical stimulation is widely used in clinical practice to manage spasticity, improve muscle strength, enhance joint mobility, and prevent contractures. Task-oriented training, on the other hand, emphasizes functional task performance and motor relearning.
Despite the widespread use of both approaches, there is limited evidence regarding their combined effectiveness. Therefore, this study is important to evaluate whether integrating NMES with task-oriented training can provide superior outcomes in upper limb rehabilitation after stroke.
- Conditions
- Stroke
- Being tested
- Neuromuscular electrical stimulation, Task-oriented training, Designed physical therapy program
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationDevice
Surface electrodes will be applied over the motor points of the supraspinatus and deltoid muscles on the paretic side, as well as over the wrist extensors on the dorsal forearm. Electrical stimulation will be delivered using a symmetrical biphasic waveform at a frequency of 30 Hz and a pulse width of 300 μs, with ramp-up and ramp-down times of 1 second each. The current intensity will be adjusted to the patient's maximum tolerance, up to 90 mA. The intervention will be administered for 30 minutes, three times per week, over a period of 6 weeks using the Gymna 400 Series device, with patients positioned in sitting, while participants in Group 2 will not receive electrical stimulation.
Task-oriented trainingOther
Task-specific training (TST) will include six functional tasks based on the motor relearning approach: drinking from a glass, lifting a cup to 90° shoulder flexion, transferring tennis balls, table polishing, moving a cone, and hair combing. Each session will last 60 minutes (10-minute warm-up + 50-minute training). Tasks will be repeated 10-20 times for 1-5 sets or 2-5 minutes, with 2-minute rest breaks every 15 minutes. Tasks will be demonstrated using the non-affected upper limb. Performance will be passive or assisted depending on ability, with gradual progression in speed, distance, and resistance. Verbal, visual, and proprioceptive feedback will be provided to ensure proper execution.
Designed physical therapy programOther
Patients will receive a designed physical therapy program in the form of stretching exercises and strengthening exercises, three times per week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular electrical stimulation + Designed physical therapy program | Active comparator | It will receive neuromuscular electrical stimulation addition to the designed physical therapy program, 3 times per week for 6 weeks. Receives: Device: Neuromuscular electrical stimulation; Other: Designed physical therapy program |
| Task-oriented training + Designed physical therapy program | Active comparator | It will receive task-oriented training, in addition to receiving a designed physical therapy program, 3 times per week for 6 weeks. Receives: Other: Task-oriented training; Other: Designed physical therapy program |
| Neuromuscular electrical stimulation + Task-oriented training + Designed physical therapy program | Experimental | It will receive neuromuscular electrical stimulation with task-oriented training in addition to the designed physical therapy program, 3 times per week for 6 weeks. Receives: Device: Neuromuscular electrical stimulation; Other: Task-oriented training; Other: Designed physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)
The FMA-UE will be used to assess upper limb motor impairment in stroke patients. It consists of 33 items evaluating reflex activity, movement synergies, coordination, sensation, and joint range of motion of the affected limb. Each item is scored on a 3-point scale (0-2), with a maximum score of 66 indicating full motor recovery. The assessment takes approximately 30 minutes and demonstrates high reliability. In this study, it will be applied to the affected upper extremity before and after the intervention.
Measured: 6 weeks
Action Research Arm Test (ARAT):
The ARAT will be used to evaluate upper limb functional performance. It includes four subtests (grasp, grip, pinch, and gross movement) using standardized objects. Patients will be seated with the affected arm supported, and tasks will assess the ability to handle objects of varying sizes and perform functional movements. Each task is scored from 0 to 3, with a maximum score of 57 indicating optimal function. The ARAT provides a comprehensive measure of hand function and dexterity.
Measured: 6 weeks
Modified Ashworth Scale (MAS):
The MAS will be used to assess spasticity in the affected upper limb. It is a 6-point ordinal scale ranging from 0 (no increase in muscle tone) to 4 (rigidity in flexion or extension), with 1+ indicating slight resistance through less than half the range. This scale is widely used in stroke populations and has established validity for assessing muscle tone. MAS scores will be recorded before and after treatment.
Measured: 6 weeks
Kinovea Software (Kinematic Analysis):
Kinovea software will be used to analyze upper limb kinematics during functional tasks. It provides valid and reliable measurements of joint angles and distances using video-based motion analysis. In this study, it will assess the range of motion of the shoulder, elbow, and wrist during the reach-and-grasp phase. This tool allows objective quantification of movement quality and coordination.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Nov 2025
- Primary completion1 Mar 2026
- Study completion31 Mar 2026
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Abdelhady Ali, Cairo University
- Investigators
- Nagwa Ibrahim Rehab, PhD, Study chair, Ass. Professor, Cairo UniversityShaima Mohamed Abdelmageed, PhD, Study director, Ass. Professor, Cairo UniversityEbtesam Mohamed Fahmy, PhD, Study director, Professor, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531381
- Sponsor's protocol ID
- P.T.REC/012/005545
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Electrical Stimulation With Task Oriented Training on Upper Extremity Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT07531381
- Acronym / sponsor ID
- P.T.REC/012/005545
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 15 Apr 2026 (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.
The current study aims to determine the effect of neuromuscular electrical stimulation combined with task-oriented training on upper limb function in patients with stroke.
Detailed description
Upper limb dysfunction following stroke is a major cause of disability, limiting independence in daily activities and reducing quality of life. Improving upper limb function is therefore a primary goal in stroke rehabilitation.
Neuromuscular electrical stimulation is widely used in clinical practice to manage spasticity, improve muscle strength, enhance joint mobility, and prevent contractures. Task-oriented training, on the other hand, emphasizes functional task performance and motor relearning.
Despite the widespread use of both approaches, there is limited evidence regarding their combined effectiveness. Therefore, this study is important to evaluate whether integrating NMES with task-oriented training can provide superior outcomes in upper limb rehabilitation after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular electrical stimulation + Designed physical therapy program | Active comparator | Device: Neuromuscular electrical stimulation, Other: Designed physical therapy programIt will receive neuromuscular electrical stimulation addition to the designed physical therapy program, 3 times per week for 6 weeks. |
| Task-oriented training + Designed physical therapy program | Active comparator | Other: Task-oriented training, Other: Designed physical therapy programIt will receive task-oriented training, in addition to receiving a designed physical therapy program, 3 times per week for 6 weeks. |
| Neuromuscular electrical stimulation + Task-oriented training + Designed physical therapy program | Experimental | Device: Neuromuscular electrical stimulation, Other: Task-oriented training, Other: Designed physical therapy programIt will receive neuromuscular electrical stimulation with task-oriented training in addition to the designed physical therapy program, 3 times per week for 6 weeks. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Forty-five stroke patients both genders (male and female)
- Patients Diagnosed with first-time ischemic/hemorrhagic stroke by their treating neurologists and confirmed by MRI scan.
- Middle cerebral artery stroke patient.
- Their ages range from 55-65 years.
- All patients were reported medically stable by their neurologist with a stroke incidence range between 6 and 24 months.
Key exclusion criteria (6 listed)
- Other neurological disorders that cause motor deficits, such as Parkinson's disease, peripheral neuropathy, and diabetes mellitus.
- Severe aphasia, resulting in communication difficulties that could influence the intervention and outcome measures.
- Cognitive impairment resulting in cooperation difficulties (a score of ≤24 in the Mini-Mental State Examination).
- Severe pain impeding upper extremity rehabilitation (Numeric Pain Rating Scale score ≥7).
- Significant visual dysfunction.
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 |
|---|---|---|
| Neuromuscular electrical stimulationSurface electrodes will be applied over the motor points of the supraspinatus and deltoid muscles on the paretic side, as well as over the wrist extensors on the dorsal forearm. Electrical stimulation will be delivered using a symmetrical biphasic waveform at a frequency of 30 Hz and a pulse width of 300 μs, with ramp-up and ramp-down times of 1 second each. The current intensity will be adjusted to the patient's maximum tolerance, up to 90 mA. The intervention will be administered for 30 minutes, three times per week, over a period of 6 weeks using the Gymna 400 Series device, with patients positioned in sitting, while participants in Group 2 will not receive electrical stimulation. | Device | Neuromuscular electrical stimulation + Designed physical therapy program, Neuromuscular electrical stimulation + Task-oriented training + Designed physical therapy program |
| Task-oriented trainingTask-specific training (TST) will include six functional tasks based on the motor relearning approach: drinking from a glass, lifting a cup to 90° shoulder flexion, transferring tennis balls, table polishing, moving a cone, and hair combing. Each session will last 60 minutes (10-minute warm-up + 50-minute training). Tasks will be repeated 10-20 times for 1-5 sets or 2-5 minutes, with 2-minute rest breaks every 15 minutes. Tasks will be demonstrated using the non-affected upper limb. Performance will be passive or assisted depending on ability, with gradual progression in speed, distance, and resistance. Verbal, visual, and proprioceptive feedback will be provided to ensure proper execution. | Other | Neuromuscular electrical stimulation + Task-oriented training + Designed physical therapy program, Task-oriented training + Designed physical therapy program |
| Designed physical therapy programPatients will receive a designed physical therapy program in the form of stretching exercises and strengthening exercises, three times per week for 6 weeks. | Other | Neuromuscular electrical stimulation + Designed physical therapy program, Neuromuscular electrical stimulation + Task-oriented training + Designed physical therapy program, Task-oriented training + Designed physical therapy program |
Primary outcome
Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)
Time frame: 6 weeks
The FMA-UE will be used to assess upper limb motor impairment in stroke patients. It consists of 33 items evaluating reflex activity, movement synergies, coordination, sensation, and joint range of motion of the affected limb. Each item is scored on a 3-point scale (0-2), with a maximum score of 66 indicating full motor recovery. The assessment takes approximately 30 minutes and demonstrates high reliability. In this study, it will be applied to the affected upper extremity before and after the intervention.
Action Research Arm Test (ARAT):
Time frame: 6 weeks
The ARAT will be used to evaluate upper limb functional performance. It includes four subtests (grasp, grip, pinch, and gross movement) using standardized objects. Patients will be seated with the affected arm supported, and tasks will assess the ability to handle objects of varying sizes and perform functional movements. Each task is scored from 0 to 3, with a maximum score of 57 indicating optimal function. The ARAT provides a comprehensive measure of hand function and dexterity.
Modified Ashworth Scale (MAS):
Time frame: 6 weeks
The MAS will be used to assess spasticity in the affected upper limb. It is a 6-point ordinal scale ranging from 0 (no increase in muscle tone) to 4 (rigidity in flexion or extension), with 1+ indicating slight resistance through less than half the range. This scale is widely used in stroke populations and has established validity for assessing muscle tone. MAS scores will be recorded before and after treatment.
Kinovea Software (Kinematic Analysis):
Time frame: 6 weeks
Kinovea software will be used to analyze upper limb kinematics during functional tasks. It provides valid and reliable measurements of joint angles and distances using video-based motion analysis. In this study, it will assess the range of motion of the shoulder, elbow, and wrist during the reach-and-grasp phase. This tool allows objective quantification of movement quality and coordination.
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 15 Apr 2026.
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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.
Nagwa Ibrahim Rehab, PhD study chair
Ass. Professor, Cairo University
Shaima Mohamed Abdelmageed, PhD study director
Ass. Professor, Cairo University
Ebtesam Mohamed Fahmy, PhD study director
Professor, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation, Task-oriented training and Designed physical therapy program in people with Stroke, 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 7 inclusion and 6 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 15 Apr 2026. 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?
Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) (time frame: 6 weeks). 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 15 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.