Clinical trial NCT06826976: Influence of Sensory Electrical Stimulation on Hand Functions in Chronic Stroke Patients
Official title: Influence of Sensory Electrical Stimulation on Hand Functions in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke
Hand Functionality
Keywords: stroke
hand function
sensory electrical nerve stimulation
task specific training
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the context of the study on sensory electrical nerve stimulation (SENS) for chronic stroke patients, a parallel assignment model was utilized. 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.

This design facilitated a direct comparison between the two groups to assess the added benefit of incorporating SENS into the rehabilitation program.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hand grip strength
timeFrame: From enrollment to the end of treatment at end of 4th week
measure: wrist range of motion
timeFrame: From enrollment to the end of treatment at end of 4th week
measure: pinch strength
timeFrame: From enrollment to the end of treatment at end of 4th week
measure: hand functions
timeFrame: From enrollment to the end of treatment at end of 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
References: