Efficacy of Functional Electrical Stimulation (FES) Combined With Task- Oriented Training on Upper Limb Recovery in Post-Stroke Patients With Spastic Hemiparesis: A Randomized Controlled Trial
| Registry | NCT07513714, acronym ESTIM-UL |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 40 (Estimated) |
| Sponsor | University of Foggia (Other) |
| Conditions | Stroke, Post-Stroke Spasticity, Post-Stroke Hemiparesis |
| Interventions | Functional Electrical Stimulation (FES), Conventional Rehabilitation (Device, other) |
| Dates | start 2026-05-01, primary completion 2026-10-01 (estimated), completion 2026-12-01 (estimated), first posted 2026-04-07, last updated 2026-09-22 |
| Locations | 1 site in Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for Stroke All trials for Post-Stroke Spasticity All trials of Functional Electrical Stimulation (FES) All trials of Conventional Rehabilitation
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.
Stroke remains one of the leading causes of long-term disability worldwide. Among its most disabling and persistent sequelae is impairment of upper limb motor function, affecting approximately 50-80% of stroke survivors in the acute phase and persisting in a substantial proportion of patients over time. Incomplete recovery of manual dexterity and fine motor control significantly limits independence in activities of daily living and negatively impacts quality of life. A major factor limiting upper limb recovery after stroke is the development of spasticity, a sensorimotor disorder resulting from upper motor neuron lesions. Upper limb spasticity typically evolves toward pathological flexor synergies which, if left untreated, lead to increased muscle tone, altered muscle-tendon properties, soft tissue shortening, and fixed joint deformities. These changes interfere with voluntary motor control, functional use of the limb, hygiene, and caregiving.
Current international guidelines identify focal injection of Botulinum Toxin Type A (BoNT-A) as the first-line treatment for focal upper limb spasticity. By blocking presynaptic acetylcholine release at the neuromuscular junction, BoNT-A induces a temporary chemical denervation that effectively reduces muscle overactivity. However, clinical experience and scientific evidence consistently demonstrate a frequent dissociation between technical success, defined as reduction in spasticity scores, and functional success, defined as improved active use of the upper limb. Reduction of muscle tone alone, although necessary, is not sufficient to restore voluntary motor control in a damaged central nervous system unless it is integrated into an intensive neuromotor rehabilitation program.
This observation has led to the concept of a "therapeutic window," in which BoNT-A reduces peripheral biomechanical resistance, creating favorable conditions that must be exploited through targeted adjunctive rehabilitation therapies. Among these, Task-Oriented Training (TOT), based on repetitive and intensive practice of meaningful functional tasks, represents one of the most effective approaches to promote post-stroke neuroplasticity.
Nevertheless, in patients with moderate to severe paresis, insufficient voluntary muscle activation often limits the effective execution of task-oriented exercises.
In this context, Functional Electrical Stimulation (FES) emerges as a key rehabilitative technology. Beyond inducing muscle contraction through peripheral nerve stimulation, FES acts as a powerful modulator of cortical plasticity. When synchronized with the patient's voluntary movement attempts, FES provides enhanced somatosensory feedback to the sensorimotor cortex. The coupling of motor intention, assisted execution, and afferent feedback reinforces synaptic connections according to Hebbian learning principles. Despite a strong neurophysiological rationale, there remains a lack of rigorous randomized controlled trials quantifying the specific added value of FES when combined with task- oriented rehabilitation in patients treated with BoNT-A. The present study is based on the hypothesis that applying FES to wrist and finger extensor muscles during Task-Oriented Training, in post-stroke patients previously treated with BoNT-A to inhibit spastic flexor muscles, produces a synergistic effect superior to conventional task-oriented rehabilitation alone. By simultaneously reducing spasticity-related resistance and enhancing muscle recruitment and cortical plasticity, this multimodal approach is expected to result in greater improvements in manual dexterity and overall upper limb function.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Functional Electrical Stimulation plus Task-Oriented Training | Experimental | Device: Functional Electrical Stimulation (FES) | Participants in the experimental arm receive Task-Oriented Training of the affected upper limb with Functional Electrical Stimulation (FES) applied to upper limb muscles based on the movement. FES is delivered using a wireless stimulation system and is synchronized with the participant's voluntary movement attempts to facilitate active motor execution. The first module includes active Task-Oriented Training of the paretic upper limb, such as reaching, grasping, and object manipulation. During task execution, Functional Electrical Stimulation is applied to upepr limb muscles and is synchronized with the participant's voluntary movement attempts to facilitate active motor execution and provide proprioceptive feedback.The second module consists of conventional physiotherapy focused on joint mobilization (passive and active-assisted movements) and muscle stretching. Each session lasts 60 minutes and is conducted 5 days per week for 2 consecutive weeks (10 sessions total). |
| Task-Oriented Training with Conventional Rehabilitation | Active comparator | Other: Conventional Rehabilitation | Participants in the control arm receive Task-Oriented Training of the affected upper limb with conventional manual facilitation provided by a physiotherapist, without electrical stimulation. The first module includes Task-Oriented Training of the paretic upper limb, such as reaching, grasping, and object manipulation. When required, assistance to movement is provided manually by the physiotherapist through neuromuscular facilitation techniques, without Functional Electrical Stimulation. The second module consists of conventional physiotherapy focused on joint mobilization and muscle stretching, identical to that delivered in the experimental arm. Each session lasts 60 minutes and is conducted 5 days per week for 2 consecutive weeks (10 sessions total). |
Sex: All, ages: 18 Years to 80 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Università degli studi di Foggia | Foggia, Foggia | Italy | Recruiting |