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Recruiting Not applicable

Percutaneous Ultrasound-guided Neuromodulation to Improve Gait Rehabilitation in Patients Who Have Suffered a Stroke.

NCT07196878 · tracked via the Priya Life Science Spain tracker
Sponsor
Alejandro Martín García
Phase
Not applicable
Started
2025-09-15
Last updated
2026-06-12

Condition(s) studied

IctusGait Disorders, Neurologic

Investigational drug(s) / intervention(s)

Ultrasound-Guided Percutaneous Neuromodulation

Ultrasound-Guided Percutaneous Neuromodulation: An ultrasound-guided puncture is performed to place one needle near the sciatic nerve and another near the peroneal nerve. Then, an electrical stimulus at 10 Hz is applied for 10 seconds, repeated 10 times.

Study summary

The goal of this clinical trial is to learn if percutaneous ultrasound-guided neuromodulation (NMP-e) can improve gait rehabilitation in adults who have suffered a stroke. The main questions it aims to answer are:

* Does NMP-e improve walking speed in stroke survivors?
* Does NMP-e enhance muscle strength, functional mobility, reduce spasticity, improve balance, and increase health-related quality of life?

Researchers will compare the addition of NMP-e to conventional physiotherapy versus conventional physiotherapy alone to see if the intervention provides additional benefits in gait rehabilitation and other functional outcomes.

Participants will:

* Continue their regular physiotherapy treatment consisting of passive and active-assisted mobilizations and strength exercises.
* Receive NMP-e targeting the sciatic nerve at mid-thigh and the common peroneal nerve at the fibular head (experimental group only).
* Undergo stimulation with an electrostimulator at 10 Hz for 10 seconds per trial, repeated 10 times, with intensity adjusted for comfort.
* Be evaluated before the intervention, immediately after, and one week later using:
* 10-Meter Walk Test for gait speed
* Dynamometry for ankle plantarflexor and dorsiflexor strength
* Time Up and Go test for functional mobility
* Modified Modified Ashworth Scale for spasticity
* Berg Balance Scale for balance
* EuroQoL-5 Dimensions for health-related quality of life

Participants must be adults aged 18-70, able to walk 10 meters without assistance, currently receiving physiotherapy, and able to provide informed consent. Key exclusions include pregnancy, bleeding disorders, needle allergies, systemic inflammatory disorders, or recent invasive physiotherapy.

This randomized controlled trial will be conducted at ATECE, \*\*a Spanish association dedicated to the care and rehabilitation of individuals with acquired brain injury\*\*, where participants will be recruited and receive their interventions. The study aims to evaluate the potential of NMP-e as an adjunctive therapy for improving gait and related functional outcomes in subacute and chronic stroke patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Be between 18 and 70 years of age; 2. Have suffered a stroke (CVA); 3. Be in the subacute or chronic phase of the disease; 4. Be able to walk 10 meters without assistance from another person; 5. Currently be undergoing physiotherapy with conservative techniques; 6. Be able to understand the technique being applied; 7. Sign the informed consent form. Exclusion Criteria: 1. Belonephobia (fear of needles); 2. Allergy to needles or metals; 3. Presence of uncontrolled coagulopathies; 4. Presence of uncontrolled arterial disease; 5. Pregnancy; 6. Dermatological disorders; 7. Presence of diseases such as systemic inflammatory disorders (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or septic arthritis); 8. Presence of diseases such as tumors, cancer, or metastases; 9. Having received invasive physiotherapy treatment in the last 4 weeks.

Primary outcome measure(s)

  • Velocidad — This variable will be measured before, immediately after, and one week later.
    The speed will be measured using the 10-Meter Walk Test.

Trial sites (1)

FacilityCityRegionStatus
Universidad de Zaragoza Zaragoza Aragon Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07196878 on ClinicalTrials.gov ↗ ← All trials in Spain