Stroke
Conditions
Brief 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.
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.
Interventions
DEVICENeuromuscular electrical stimulation
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-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.
Patients will receive a designed physical therapy program in the form of stretching exercises and strengthening exercises, three times per week for 6 weeks.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) | 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): | 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): | 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): | 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. |
Countries
Egypt
Contacts
STUDY_CHAIRNagwa Ibrahim Rehab, PhD
Ass. Professor, Cairo University
STUDY_DIRECTORShaima Mohamed Abdelmageed, PhD
Ass. Professor, Cairo University
STUDY_DIRECTOREbtesam Mohamed Fahmy, PhD
Professor, Cairo University
Outcome results
None listed