Effect of Neuromuscular Electrical Stimulation With Task Oriented Training on Upper Extremity Function in Stroke Patients

NCT07531381 | Completed

• 1 other identifier: P.T.REC/012/005545
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  6 weeks

Study Arms (3)

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.

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.

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.

Device: Neuromuscular electrical stimulation; Other: Task-oriented training; Other: Designed physical therapy program

Interventions

Neuromuscular electrical stimulation DEVICE

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.

Neuromuscular electrical stimulation + Designed physical therapy program; Neuromuscular electrical stimulation + Task-oriented training + Designed physical therapy program

Task-oriented training OTHER

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.

Neuromuscular electrical stimulation + Task-oriented training + Designed physical therapy program; Task-oriented training + Designed physical therapy program

Designed physical therapy program OTHER

Patients will receive a designed physical therapy program in the form of stretching exercises and strengthening exercises, three times per week for 6 weeks.

Neuromuscular electrical stimulation + Designed physical therapy program; Neuromuscular electrical stimulation + Task-oriented training + Designed physical therapy program; Task-oriented training + Designed physical therapy program

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Suez Canal University Hospital, Suez Canal University

Suez, Egypt

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nagwa Ibrahim Rehab, PhD

  Ass. Professor, Cairo University

  STUDY CHAIR

• Shaima Mohamed Abdelmageed, PhD

  Ass. Professor, Cairo University

  STUDY DIRECTOR

• Ebtesam Mohamed Fahmy, PhD

  Professor, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 15, 2026
• Study Start: November 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

EG (1)