Ultrasound-Guided Percutaneous Neuromodulation Protocol to Improve Gait Rehabilitation in Patients Who Have Suffered a Stroke. Clinical Trial.

This study is designed to evaluate the effectiveness of ultrasound-guided percutaneous neuromodulation (PNM) combined with conventional physiotherapy in improving gait and functional outcomes in adults recovering from subacute to chronic stroke. Stroke is a leading cause of long-term disability worldwide, frequently resulting in impaired motor control, reduced muscle strength, altered gait patterns, and decreased functional independence. Conventional physiotherapy remains the cornerstone of post-stroke rehabilitation, focusing on exercises to enhance strength, coordination, balance, and mobility. However, recovery is often incomplete, and additional interventions that can augment neuroplasticity and motor recovery are critically needed.

Ultrasound-guided PNM is a minimally invasive technique that involves targeted electrical stimulation of peripheral nerves via a fine needle under ultrasound guidance. By stimulating the sciatic and deep peroneal nerves, PNM may enhance neuromuscular activation, improve muscle recruitment, reduce spasticity, and facilitate motor relearning. This trial seeks to determine whether integrating PNM with standard physiotherapy produces greater improvements in walking speed, lower limb strength, balance, and functional mobility compared to physiotherapy alone.

A total of 30 participants aged 18-70 years who have experienced a stroke at least three months prior and are capable of walking a minimum of 50 meters with or without assistive devices will be enrolled. Participants will be randomly assigned in a 1:1 ratio to either the experimental group, receiving ultrasound-guided PNM plus physiotherapy, or the control group, receiving physiotherapy alone. The intervention will be delivered over multiple sessions following a standardized protocol. In the experimental group, the PNM sessions will target the sciatic and deep peroneal nerves of the affected limb, using a pre-determined stimulation frequency and intensity individualized to each participant's tolerance. Physiotherapy sessions will include strength training, gait training, balance exercises, and functional mobility tasks, applied consistently across both groups.

Outcomes will be assessed at baseline, immediately post-intervention, and one week after the last treatment session to capture both immediate and short-term effects. The primary outcome measure is walking speed, assessed using the 10-Meter Walk Test, a validated and widely used metric of functional gait performance. Secondary outcomes include lower limb muscle strength (ankle dorsiflexors and plantarflexors) measured with handheld dynamometry, spasticity assessed by the Modified Modified Ashworth Scale, functional mobility evaluated using the Timed Up and Go test, balance assessed with the Berg Balance Scale, and health-related quality of life measured with the EQ-5D questionnaire.

Data will be analyzed using mixed linear and logistic regression models, accounting for repeated measures and individual variability. Safety and tolerability will be closely monitored throughout the study, with adverse events recorded and managed according to established protocols. Participants will provide informed consent and retain the right to withdraw from the study at any time without any consequences to their ongoing care.