ESTIM-UL: FES for Upper Limb Recovery After Stroke

NCT07513714 · tracked via the Priya Life Science Italy tracker

Sponsor

University of Foggia

Phase

Not applicable

Started

2026-05-01

Last updated

2026-09-22

Condition(s) studied

StrokePost-Stroke SpasticityPost-Stroke Hemiparesis

Investigational drug(s) / intervention(s)

Functional Electrical Stimulation (FES)Conventional Rehabilitation

Functional Electrical Stimulation (FES): Functional Electrical Stimulation is applied to wrist and finger extensor muscles of the paretic upper limb using a surface electrode system. Electrical stimulation is synchronized with the participant's voluntary movement attempts during Task-Oriented Training to facilitate active motor execution and sensorimotor integration. Stimulation is delivered during 60-minute rehabilitation sessions, 5 days per week for 2 consecutive weeks.

Conventional Rehabilitation: Conventional rehabilitation consists of therapist-assisted Task- Oriented Training of the paretic upper limb, including manual facilitation and guidance as needed to support task execution. No electrical stimulation is applied. Sessions last 60 minutes and are performed 5 days per week for 2 consecutive weeks.

Study summary

Stroke is a leading cause of long-term disability, frequently resulting in impaired upper limb motor function and spasticity. Although Botulinum Toxin Type A (BoNT-A) is effective in reducing focal spasticity, functional recovery of the upper limb often remains limited without intensive, task-specific rehabilitation. Functional Electrical Stimulation (FES), when synchronized with voluntary movement during Task-Oriented Training, may enhance motor recovery by facilitating muscle activation and neuroplasticity. This randomized controlled trial aims to evaluate whether FES combined with Task-Oriented Training is superior to conventional Task-Oriented Training alone in improving upper limb function in post-stroke patients treated with BoNT-A.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Age 18 years or older. * Diagnosis of ischemic or hemorrhagic stroke, documented by CT or MRI. * Clinical presence of focal upper limb spasticity, defined as a score ≥ 1+ on the Modified Ashworth Scale (MAS) in at least one target muscle group (elbow, wrist, or finger flexors), treated with Botulinum Toxin Type A injection. * Presence of residual voluntary muscle activation (minimal active movement) sufficient to initiate the motor task required by the training (Box and Block score ≥ 1). * Preserved cognitive function, defined as a Mini-Mental State Examination (MMSE) score ≥ 24 or clinical judgment confirming adequate comprehension and cooperation. Exclusion Criteria: * Absolute contraindications to Functional Electrical Stimulation (FES), including the presence of a cardiac pacemaker or implantable cardioverter defibrillator (ICD), pharmacologically uncontrolled epilepsy, or skin lesions/dermatitis at the electrode application sites. * Presence of severe muscle-tendon contractures or fixed joint deformities (ankylosis) that mechanically limit passive movement and make active functional recovery unlikely. * Severe cognitive impairment, global aphasia, or severe unilateral spatial neglect that prevents task comprehension or active participation in the training program. * Concomitant orthopedic or rheumatologic conditions affecting the upper limb (e.g., recent fractures, severe arthritis) that could interfere with treatment delivery or outcome assessment.

Primary outcome measure(s)

Change in Gross Manual Dexterity — Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)
Measured as the mean change in score on the Box and Block Test (BBT), defined as the difference in the number of blocks transferred in 60 seconds between baseline and post-treatment

Trial sites (1)

Facility	City	Region	Status
Università degli studi di Foggia	Foggia	Foggia	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07513714 on ClinicalTrials.gov ↗ ← All trials in Italy