ESTIM-UL: FES for Upper Limb Recovery After Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Foggia
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Functional Electrical Stimulation (FES)
- Conventional Rehabilitation
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov