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ESTIM-UL: FES for Upper Limb Recovery After Stroke

NCT07513714 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-07

No results posted yet for this 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.

Conditions

  • Stroke
  • Post-Stroke Spasticity
  • Post-Stroke Hemiparesis

Interventions

DEVICE

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.

OTHER

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.

Sponsors & Collaborators

  • University of Foggia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-10-01
Completion
2026-12-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07513714 on ClinicalTrials.gov