Abstract / Summary
Background and aims: Stroke is a leading cause of long-term disability, often causing upper extremity paralysis that limits daily activities. Functional electrical stimulation (FES) has been shown to promote motor recovery by activating affected muscles, but its effectiveness when combined rigorously with usual physiotherapy treatment (UPT) remains underexplored. This trial aims to assess whether FES combined with UPT improves hand pain and function in stroke patients more than UPT with placebo FES.
Methods: This prospective, randomized controlled trial will recruit 140 stroke patients, who will be randomly assigned to either the intervention group (n = 70) or the control group (n = 70). The intervention group will receive 30 min of FES applied to the wrist extensors combined with 30 min of UPT, while the control group will receive placebo FES along with the same UPT protocol, 3 days a week for 8 weeks. Outcomes will be measured at baseline, mid-intervention (week 4), post-intervention (week-8), and after 12-week follow-up (week-20). Primary outcomes will be hand pain, assessed with the Numerical Pain Rating Scale (NPRS), and upper extremity function, assessed with the Fugl-Meyer Assessment-Upper Extremity (FMA-UE). Secondary outcomes will include muscle tone, measured by the Modified Ashworth Scale (MAS), and manual dexterity, measured by the Box and Block Test (BBT).
Results: All outcomes will be assessed at baseline, mid-intervention, post-intervention, and follow-up to evaluate both short-term and sustained effects. Comparative analyses will be conducted to determine the effectiveness of FES combined with UPT versus placebo FES with UPT in improving pain and functional outcomes in stroke.
Conclusions: This trial will provide high-quality evidence regarding the adjunctive role of FES in stroke rehabilitation. The findings are expected to support evidence-based physiotherapy practice, enhance clinical decision-making, and improve functional recovery and quality of life for individuals with stroke-related upper extremity impairments. Trial Registration: CTRI/2025/07/091676.