FES for upper limb recovery after stroke in people who had BoNT-A treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares Functional Electrical Stimulation (FES) combined with Task-Oriented Training to conventional Task-Oriented Training alone for improving upper limb function in adults with stroke and residual spasticity treated with Botulinum Toxin Type A. Eligible participants have a stroke, focal spasticity in the arm, some remaining voluntary movement, and adequate cognitive function. The study aims to determine if adding FES can enhance motor recovery and functional use of the arm beyond standard rehabilitation after BoNT-A. Interventions include FES plus rehabilitation versus conventional rehabilitation, with outcomes focused on functional improvement of the upper limb.

Why it matters

Who can join: the full rules

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.

Where it's running

• Università degli studi di Foggia
  Foggia, Foggia, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.