Percutaneous Ultrasound-guided Neuromodulation to Improve Gait Rehabilitation in Patients Who Have Suffered a Stroke.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAlejandro Martín García
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Belonephobia (fear of needles);
Allergy to needles or metals;
Presence of uncontrolled coagulopathies;
Presence of uncontrolled arterial disease;
Trial design
Design model
Parallel
Treatments tested in this trial
Ultrasound-Guided Percutaneous Neuromodulation
Other interventionAn 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Ultrasound-Guided Percutaneous NeuromodulationExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Velocidad
The speed will be measured using the 10-Meter Walk Test.
Time frame
This variable will be measured before, immediately after, and one week later.Secondary outcomes
1
Isometric strength of the ankle plantarflexor and dorsiflexor muscles.
The strength of the ankle flexor and extensor muscles will be measured using a dynamometer.
Time frame
It will be measured before, immediately after, and one week following the intervention.2
Functional mobility will be assessed using the Timed Up and Go (TUG) test.
The participant will be seated in a chair until they hear the evaluator's signal to start the test. The participant must stand up, walk a total of 3 meters in a straight line, return to the chair, and resume the starting position. Three measurements will be taken, and the best result will be considered the most accurate.
Time frame
The measurement will be taken before, immediately after, and one week following the intervention.3
Spasticity will be assessed using the Modified Modified Ashworth Scale (MMAS).
Muscle tone of the hamstring and anterior tibial muscles will be measured.
Time frame
It will be measured before, immediately after, and one week following the intervention.4
Balance will be assessed using the Berg Balance Scale (BBS).
Participants will perform a total of 14 tasks, which include: standing up from a seated position, maintaining a standing position without support, sitting without leaning the back while keeping the feet on the floor or on a footrest, sitting down from a seated position, performing two transfers from one chair to another and returning to the first chair, maintaining a standing position without support with eyes closed, maintaining a standing position without support with feet together, reaching forward with an extended arm, picking up an object from the floor while standing, turning the head backward over the right and left shoulders while standing, performing a 360º turn, alternately stepping one foot onto a step or footrest while standing without support, maintaining a standing position without support with one foot forward, and maintaining a one-legged stance.
Time frame
It will be measured before, immediately after, and one week following the intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Alejandro Martín García
Lead sponsor
Universidad de Zaragoza
Sponsor institution
Source ClinicalTrials.gov