- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07531381
Effect of Neuromuscular Electrical Stimulation With Task Oriented Training on Upper Extremity Function in Stroke Patients
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Suez, Egypt
- Suez Canal University Hospital, Suez Canal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Neuromuscular electrical stimulation + Designed physical therapy program
It will receive neuromuscular electrical stimulation addition to the designed physical therapy program, 3 times per week for 6 weeks.
|
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.
Patients will receive a designed physical therapy program in the form of stretching exercises and strengthening exercises, three times per week for 6 weeks.
|
|
Active Comparator: Task-oriented training + Designed physical therapy program
It will receive task-oriented training, in addition to receiving a designed physical therapy program, 3 times per week for 6 weeks.
|
Patients will receive a designed physical therapy program in the form of stretching exercises and strengthening exercises, three times per week for 6 weeks.
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.
|
|
Experimental: Neuromuscular electrical stimulation + Task-oriented training + Designed physical therapy program
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.
|
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.
Patients will receive a designed physical therapy program in the form of stretching exercises and strengthening exercises, three times per week for 6 weeks.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 weeks
|
|
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.
|
6 weeks
|
|
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.
|
6 weeks
|
|
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.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nagwa Ibrahim Rehab, PhD, Ass. Professor, Cairo University
- Study Director: Shaima Mohamed Abdelmageed, PhD, Ass. Professor, Cairo University
- Study Director: Ebtesam Mohamed Fahmy, PhD, Professor, Cairo university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
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/012/005545
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 Stroke
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
Fondazione Don Carlo Gnocchi OnlusScuola Superiore Sant'Anna di Pisa; Fondazione Policlinico Universitario Campus...Not yet recruitingStroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke IschemicItaly
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
Clinical Trials on Neuromuscular electrical stimulation
-
Brooks RehabilitationTerminatedBlepharoptosis | LagophthalmosUnited States
-
Necmettin Erbakan UniversityCompletedCerebral Palsy (CP)Turkey (Türkiye)
-
University Hospital, BrestCompletedAsthma | Chronic Obstructive Pulmonary Disease Overlap SyndromeFrance
-
Hacettepe UniversityCompleted
-
Universidade Federal do Rio Grande do NorteNot yet recruitingHeart Failure | Heart Failure NYHA Class III | Heart Failure NYHA Class IV | Kinesiophobia | Neuromuscular Electrical Stimulation (NMES)Brazil
-
MetroHealth Medical CenterEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedStroke | Hemiparesis | FootdropUnited States
-
Ambra BisioUniversita degli Studi di GenovaActive, not recruiting
-
Hopital ForcillesNot yet recruitingDysphagia | NeuroMuscular Electrical Stimulation
-
University of Sao PauloSuspendedRehabilitation | Critical CareBrazil