Efficacy of Sensory Electrical Stimulation Versus Alternating Electromyogram (EMG) On Functional Recovery Of Hand in Chronic Stroke Survivors :Randomized Controlled Trial

NCT ID: NCT06836596

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-02-07

Brief Summary

This study aims to find out which treatment works better for improving hand function in stroke patients: sensory electrical stimulation or alternating electromyogram (EMG) stimulation. Both methods use electrical stimulation to help patients regain hand movement, but they work in slightly different ways. The goal is to see if one method is more effective than the other in helping stroke survivors recover their hand abilities.

Conditions

Chronic Stroke Survivors; Chronic Stroke Survivors With Plegic Hand

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A (Sensory Electrical Stimulation Group)

This group receives the active treatment of peripheral sensory electrical stimulation along with the hand function training program, making it the experimental group being tested for its effects on improving hand function in stroke patients.

Group Type: EXPERIMENTAL

Peripheral sensory electrical stimulation via Elettronica Pagani Roland series model: ET 20 S/N: 1907 (Made in Italy)

Intervention Type: DEVICE

Sensory electrical stimulation, Transcutaneous electrical nerve stimulation (TENS) involves delivering electrical current through electrodes placed on the skin to manage pain. It can be applied at different frequencies, ranging from low (50 Hz). The intensity can be adjusted from sensory to motor levels. Sensory intensity is when the patient experiences a strong yet comfortable sensation without triggering muscle contraction

Group B (Alternating EMG Stimulation Group)

This is because this group is receiving a different active treatment (alternating EMG stimulation) along with hand function training, and it is being compared to the other active treatment (sensory electrical stimulation) in Group A. Both groups are experimental, but Group B serves as a comparison to Group A in the study.

Group Type: ACTIVE_COMPARATOR

Alternating electromyogram (EMG) neuromuscular electrical stimulation via MyoTrac Infiniti device (T9800, Thought Technology Ltd. Montreal, Quebec, Canada)

Intervention Type: DEVICE

the device detects the EMG threshold value (peak muscle torque) of the target muscle and activates stimulation to enhance the patient's voluntary activation of the targeted muscle groups. It is used to assess peak muscle torque and deliver alternating and EMG-triggered stimulation. Surface electrodes are employed to detect electromyography in the affected muscle and administer electrical stimulation to the targeted muscle during treatment. The device stimulates the targeted muscles, after which the patient attempts to replicate the same movement until reaching the preset EMG feedback level

Group C (Control Group)

Group C only receives the designed hand function training program and does not receive any form of electrical stimulation, the electrodes are used, but no active stimulation is delivered. It serves as the control group for comparison against the experimental treatments in Groups A and B.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Peripheral sensory electrical stimulation via Elettronica Pagani Roland series model: ET 20 S/N: 1907 (Made in Italy)

Sensory electrical stimulation, Transcutaneous electrical nerve stimulation (TENS) involves delivering electrical current through electrodes placed on the skin to manage pain. It can be applied at different frequencies, ranging from low (50 Hz). The intensity can be adjusted from sensory to motor levels. Sensory intensity is when the patient experiences a strong yet comfortable sensation without triggering muscle contraction

Intervention Type: DEVICE

Alternating electromyogram (EMG) neuromuscular electrical stimulation via MyoTrac Infiniti device (T9800, Thought Technology Ltd. Montreal, Quebec, Canada)

the device detects the EMG threshold value (peak muscle torque) of the target muscle and activates stimulation to enhance the patient's voluntary activation of the targeted muscle groups. It is used to assess peak muscle torque and deliver alternating and EMG-triggered stimulation. Surface electrodes are employed to detect electromyography in the affected muscle and administer electrical stimulation to the targeted muscle during treatment. The device stimulates the targeted muscles, after which the patient attempts to replicate the same movement until reaching the preset EMG feedback level

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Chronic stroke patients were between 45 and 65 years old, with a duration of illness ranging from 6 to 18 months post-stroke. They exhibited upper extremity spasticity no greater than 1+ on the Modified Ashworth Scale. Patients were cooperative, as indicated by a Mini-Mental State Examination (MMSE) score of ≥ 24, and were capable of grasping and releasing at least one block in the Box and Block Test.

Exclusion Criteria

• Hand function impairment caused by factors other than stroke, unstable health conditions such as cardiac dysfunction, end-stage renal failure, or uncontrolled diabetes, long-term use of medications that may affect motor or sensory excitability, contractures or restrictions in wrist joint range of motion, pre-existing musculoskeletal diseases significantly impacting physical function, and a history of Botulinum Toxin injection in the hand muscles.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez University

OTHER

Sponsor Role: lead

Responsible Party

Dany Alphonse Anwar Habib

Lecturer of Physical Therapy for Neurology and Its Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of physical therapy, Cairo universuty

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004916

Identifier Type: -

Identifier Source: org_study_id