Influence of Sensory Electrical Stimulation on Hand Functions in Chronic Stroke Patients

NCT ID: NCT06826976

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-06-10

Brief Summary

This study investigates the impact of sensory electrical nerve stimulation (SENS) on hand function in chronic stroke patients. Thirty participants were randomly divided into two groups:

Study Group (A): Received SENS combined with task-specific training.

Control Group (B): Received only task-specific training.

Assessments conducted before and after the intervention included measurements of grip strength, pinch strength, wrist range of motion, and performance on the Action Research Arm Test (ARAT).

Detailed Description

This study explores the effectiveness of sensory electrical nerve stimulation (SENS) in enhancing hand function among chronic stroke patients. Thirty participants were randomly divided into two groups:

Study Group (A): Received SENS combined with task-specific training.

Control Group (B): Received only task-specific training.

Assessment Methods:

Before and after the intervention, both groups underwent evaluations using:

Grip Dynamometer: To measure grip strength.

Pinch Dynamometer: To assess pinch strength.

Digital Goniometer: To determine wrist flexion and extension range of motion.

Action Research Arm Test (ARAT): To evaluate upper limb functional performance.

Conditions

Stroke; Hand Functionality

Study Design

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

Study Groups

Sensory electrical stimulation

received sensory electrical stimulation and task specific training program

Group Type: EXPERIMENTAL

sensory electrical stimulation

Intervention Type: OTHER

peripheral sensory electrical stimulation on median, ulnar, and radial nerves of affected upper limb, simultaneously with Task Specific Training program which included four subtests of Action Research Arm Test scale.

Task specific training

received task specific training program only. Patients were tested pre and post treatment by Grip dynamometer, Pinch dynamometer, Digital goniometer and Action Research Arm Test Scale (ARAT).

Group Type: ACTIVE_COMPARATOR

task specific training program

Intervention Type: OTHER

received task specific training program only. Patients were tested pre and post treatment by Grip dynamometer, Pinch dynamometer, Digital goniometer and Action Research Arm Test Scale (ARAT).

Interventions

sensory electrical stimulation

peripheral sensory electrical stimulation on median, ulnar, and radial nerves of affected upper limb, simultaneously with Task Specific Training program which included four subtests of Action Research Arm Test scale.

Intervention Type: OTHER

task specific training program

received task specific training program only. Patients were tested pre and post treatment by Grip dynamometer, Pinch dynamometer, Digital goniometer and Action Research Arm Test Scale (ARAT).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients who have experienced their first-ever ischemic stroke in the carotid system domain.
• Age range: 40 to 65 years old.
• Duration of illness: 30 to 180 days since stroke onset.
• Spasticity of the affected hand muscles (wrist flexors, finger flexors, and finger adductors) must be grade 1+ or less according to the Modified Ashworth Scale.
• Hand dysfunction severity ranges from mild to severe, defined by a score of ≤ 4 on the Medical Research Council Scale.

Exclusion Criteria

• Presence of a deformity in the paralytic upper limb before the stroke.
• History of a lower motor neuron lesion in the impaired upper extremity (e.g., polyneuropathy) before the stroke.
• Skin abrasions or ulcerations on the affected upper limb.
• Unstable health conditions, including cardiac dysfunction, end-stage renal failure, unstable diabetes, or uncontrolled hypertension (>190/110).
• Presence of a pacemaker or other implanted electrically sensitive devices.
• Significant orthopedic conditions or chronic pain syndromes.
• Chronic use of medications that may influence motor or sensory excitability (e.g., anti-epileptic or antipsychotic drugs).
• Pregnancy.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Islam Hassan Fayed

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Giza, Giza Governorate, Egypt

Countries

Egypt

Other Identifiers

P.T. REC/012/005208

Identifier Type: -

Identifier Source: org_study_id