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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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Italy
Università degli studi di Foggia
RECRUITING
Foggia
Time Frame
Start Date: 2026-05-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 40
Treatments
Experimental: Functional Electrical Stimulation plus Task-Oriented Training
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).
Active_comparator: Task-Oriented Training with 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).
Related Therapeutic Areas
Sponsors
Leads: University of Foggia

This content was sourced from clinicaltrials.gov