Influence of Sensory Electrical Stimulation on Hand Functions in Chronic Stroke Patients (SES-Hand)

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Stroke; Hand Functionality
• Intervention / Treatment: Other: sensory electrical stimulation; Other: task specific training program

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 11835
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sensory electrical stimulation; received sensory electrical stimulation and task specific training program	Other: 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.
Active Comparator: 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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand grip strength	The patient seated with his/her shoulder adducted and naturally rotated, elbow flexed at 90 degrees, forearm in neutral position, and wrist between 0- and 30-degrees dorsiflexion and between 0- and 15-degrees ulnar deviation. The Jamar hand dynamometer was set to the second handle position from the inside. Lightly hold around the readout dial to prevent inadvertent dropping. After the patient was positioned properly, the following statement was used "Squeeze as hard as you can…. harder …. harder…. relax" (16). The scores of three successive trials were recorded for each tested hand. The average score of three trials was compared to the normative data on the other side, which is in pounds.	From enrollment to the end of treatment at end of 4th week
wrist range of motion	Goniometer was used to assess wrist flexion-extension.	From enrollment to the end of treatment at end of 4th week
pinch strength	Three types of pinches were typically evaluated because they are involved in accomplishing occupational tasks and activities efficiently. In Tip Pinch: The patient pinched the ends of the pinch meter between the tips of the thumb and index finger. The test was administered by first giving the patient instructions and a demonstration, "Ready? Pinch as hard as you can." The patient was urged on as he or she attempted to pinch. The average of three trials was recorded. In Lateral Pinch (Key Pinch): The patient pinched the meter between the pad of the thumb and the lateral surface of the index finger. In Palmar Pinch (Three-Jaw Chuck): The patient pinched the meter between the pad of the thumb and the pads of the index and middle fingers	From enrollment to the end of treatment at end of 4th week
hand functions	Patients who achieve a maximum score on the first (most difficult) item are credited with having scored 3 on all subsequent items on that scale. If the patient scores less than 3 on the first item, then the second item is assessed. This is the easiest item, and if patients score 0 then they are unlikely to achieve a score above 0 for the remainder of the items and are credited with a zero for the other items. The maximum score on ARTS is 57 points (possible range 0 to 57).	From enrollment to the end of treatment at end of 4th week

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 10, 2025

Study Registration Dates

• First Submitted: February 2, 2025
• First Submitted That Met QC Criteria: February 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: stroke; hand function; task specific training; sensory electrical nerve stimulation
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: P.T. REC/012/005208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No