NCT06017960 Effects of Dry Needling on Electromyographic Activity and Ultrasonographic Characteristics in Post-Stroke Spasticity
| NCT ID | NCT06017960 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad de Zaragoza |
| Condition | Spasticity as Sequela of Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2023-09-15 |
| Primary Completion | 2026-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 28 participants in total. It began in 2023-09-15 with a primary completion date of 2026-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Stroke is a global health problem, with an incidence in Europe of 147/100,000 people per year. It is estimated that 43% of them present spasticity throughout the first year, causing disability, hindering mobility and functionality, which can generate comorbidity problems, which in turn hinders its improvement over time. Recently, high quality studies have conclude that there is a moderate level of evidence with large effect size in reducing spasticity with dry needling, as well as being cost-effective in stroke patients in both the subacute and chronic phases. However, due to the limitation of manual evaluations of spasticity, and it is necessary to look for measurement alternatives that complement it, such as the analysis of the electromyographic activity and the muscular structure measured with ultrasound. These data could provide objective, useful and complementary information to clinical assessments to be more specific and effective in the treatment of stroke patients. This randomized controlled trial aim to analyse the effect of dry needling in this parameters in patients with stroke and spasticity, as well as correlated with gait variables. Each participant will be randomly assigned to the dry needling group or to the sham dry needling group, where participants receive a total of 4 sessions of ultrasound-guided dry needling or sham ultrasound-guided dry needling in the gastrocnemius medialis over 4 weeks, one per week. Measures of spasticity, electromyographic activity and muscle structure via ultrasound will made at baseline (T0) and immediate after each intervention (T1,T2,T3,T4). Gait variables will be made at baseline and after the last intervention (T0 and T4).
Eligibility Criteria
Inclusion Criteria: * be over 18 years old * understand and voluntarily sign informed consent before performing the intervention * have a medical diagnosis of ischemic or hemorrhagic stroke * have a grade between 1-3 according to the modified Ashworth scale (MAS) on the triceps sural * able to walk independently to perform gait test Exclusion Criteria: * recurrent stroke * who have received previous treatments of botulinum toxin type A in the last 3 months * who have received treatments with dry needling in the last month * severe cognitive deficits * fear of needles * metal allergy.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06017960 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spasticity as Sequela of Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06017960 currently recruiting?
Yes, NCT06017960 is actively recruiting participants. Contact the research team at pherrero@unizar.es for enrollment information.
Where is the NCT06017960 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06017960 clinical trial?
NCT06017960 is sponsored by Universidad de Zaragoza. The trial plans to enroll 28 participants.
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