Ultrasound-guided needle nerve stimulation to improve walking after stroke
Ultrasound-Guided Percutaneous Neuromodulation Protocol to Improve Gait Rehabilitation in Patients Who Have Suffered a Stroke. Clinical Trial.
This trial will test whether adding ultrasound-guided percutaneous nerve stimulation to regular physiotherapy helps adults who have had a stroke walk faster and move better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Universidad de Zaragoza Academic / other |
| Locations | 1 site (Zaragoza, Aragon) |
| Trial ID | NCT07196878 on ClinicalTrials.gov |
What this trial studies
This interventional study compares standard physiotherapy alone versus physiotherapy plus ultrasound-guided percutaneous neuromodulation (PNM) targeted to the sciatic and common peroneal nerves. About 30 adults at least three months after stroke who can walk independently for short distances will be enrolled and receive usual rehabilitation while the experimental group also receives needle-based nerve stimulation under ultrasound. Stimulation sessions use a fine needle placed near the nerve with brief electrical pulses (e.g., 10 Hz for short trains) alongside conventional strength, mobility, and balance exercises. Outcomes include walking speed, lower-limb strength, spasticity, balance, functional mobility, and health-related quality of life over the treatment period.
Who should consider this trial
Good fit: Adults aged 18–70 who are in the subacute or chronic phase of stroke (at least three months post-event), able to walk independently for short distances (about 10 meters), currently receiving physiotherapy, and able to consent are ideal candidates.
Not a fit: People with needle phobia, uncontrolled bleeding disorders, active systemic inflammatory disease, recent invasive physiotherapy, pregnancy, certain skin or oncologic conditions, or those unable to attend site visits or walk independently are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could speed walking recovery, increase leg strength, reduce spasticity, and improve balance and daily function for some stroke survivors.
How similar studies have performed: Small pilot studies and other peripheral neuromodulation approaches have shown promising but limited improvements in motor recovery after stroke, while ultrasound-guided percutaneous nerve stimulation remains a relatively novel and not yet widely validated technique.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Zaragoza, Aragon
- Universidad de Zaragoza — Zaragoza, Aragon, Spain (Recruiting)
Study contacts
- Study coordinator: Alejandro Martín García
- Email: alejandro140martin@gmail.com
- Phone: +34655856799
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.