ESTIM-UL: FES for Upper Limb Recovery After Stroke
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Functional Electrical Stimulation (FES)
DeviceFunctional 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
Other interventionConventional 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Functional Electrical Stimulation plus Task-Oriented TrainingExperimental treatment 1 intervention
Group B: Task-Oriented Training with Conventional RehabilitationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Gross Manual Dexterity
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
Time frame
Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)Secondary outcomes
1
Upper Limb Muscle Strength
Change in upper limb muscle strength measured by the Motricity Index (MI) for the upper limb (score range: 0 to 100, with higher scores indicating greater muscle strength). The MI assesses strength at proximal, middle, and distal joints of the upper limb.
Time frame
Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)2
Upper Limb Muscle Tone
Change in muscle tone measured by the Modified Ashworth Scale (MAS) (ordinal scale ranging from 0 to 4, with higher scores indicating greater spasticity), assessed in elbow, wrist, and finger flexor muscles.
Time frame
Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)3
Spasticity-related Quality of Life 6-Dimensions (SQoL-6D)
Condition-specific assessment of spasticity-related quality of life. SQoL-6D replaced the originally registered EQ-5D-5L as the quality-of-life outcome.
Time frame
Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)Sponsors and contacts
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Source ClinicalTrials.gov