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

NCT07196878 | Recruiting

• 1 other identifier: C.I. PI25/059
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ictus; Gait Disorders, Neurologic

Keywords

ICTUS; Gait disorder; Ultrasound guided neuromodulation

Outcome Measures

Primary Outcomes (1)

• Velocidad

  The speed will be measured using the 10-Meter Walk Test.

  This variable will be measured before, immediately after, and one week later.

Secondary Outcomes (5)

• Isometric strength of the ankle plantarflexor and dorsiflexor muscles.

  It will be measured before, immediately after, and one week following the intervention.

• Functional mobility will be assessed using the Timed Up and Go (TUG) test.

  The measurement will be taken before, immediately after, and one week following the intervention.

• Spasticity will be assessed using the Modified Modified Ashworth Scale (MMAS).

  It will be measured before, immediately after, and one week following the intervention.

• Balance will be assessed using the Berg Balance Scale (BBS).

  It will be measured before, immediately after, and one week following the intervention.

• Health-related quality of life will be assessed using the EuroQoL-5 Dimensions (EQ-5D) scale.

  The scale will be administered before, immediately after, and one week following the intervention.

Study Arms (2)

Ultrasound-Guided Percutaneous Neuromodulation

EXPERIMENTAL

Ultrasound-guided percutaneous neuromodulation is performed 10 times, each lasting 10 seconds with 10-second rest intervals.

Other: Ultrasound-Guided Percutaneous Neuromodulation

Control group

NO INTERVENTION

Control group that does not receive the intervention; it is used solely for comparison.

Interventions

Ultrasound-Guided Percutaneous Neuromodulation OTHER

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.

Ultrasound-Guided Percutaneous Neuromodulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between 18 and 70 years of age;
• Have suffered a stroke (CVA);
• Be in the subacute or chronic phase of the disease;
• Be able to walk 10 meters without assistance from another person;
• Currently be undergoing physiotherapy with conservative techniques;
• Be able to understand the technique being applied;
• Sign the informed consent form.

You may not qualify if:

• Belonephobia (fear of needles);
• Allergy to needles or metals;
• Presence of uncontrolled coagulopathies;
• Presence of uncontrolled arterial disease;
• Pregnancy;
• Dermatological disorders;
• Presence of diseases such as systemic inflammatory disorders (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or septic arthritis);
• Presence of diseases such as tumors, cancer, or metastases;
• Having received invasive physiotherapy treatment in the last 4 weeks.

Sponsors & Collaborators

• Alejandro Martín García: lead

Study Sites (1)

Universidad de Zaragoza

Zaragoza, Aragon, 50009, Spain

RECRUITING

MeSH Terms

Conditions

Gait Disorders, Neurologic; Mobility Limitation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alejandro Martín García

CONTACT

+34655856799; alejandro140martin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ultrasound-Guided Percutaneous Neuromodulation Protocol to Improve Gait Rehabilitation in Patients Who Have Suffered a Stroke. Clinical Trial.

Model Details: An intervention group receiving the procedure in addition to their usual treatment is compared with a control group that receives only their usual treatment (the same as the intervention group).

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 29, 2025
• Study Start: September 15, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)