Comparing Dry Needling and Botulinum Toxin for Post-Stroke Spasticity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a randomized parallel group study conducted in Spain, Canada, and Belgium, aimed at comparing the effectiveness of Botulinum Toxin type A (BTX-A) and Dry Needling (DN) in treating lower limb spasticity in patients who have experienced a first stroke within the last 12 months. Participants will be randomly assigned to receive either one session of BTX-A or 12 weekly sessions of DN. The study will assess the effects of these treatments on spasticity using blinded evaluators before, during, and after treatment, with a follow-up at four weeks. The primary hypothesis is that DN will have comparable effects to BTX-A in reducing spasticity by decreasing stretch reflex excitability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. aged 18-75 years.
2. post-stroke spasticity in ankle plantar flexors (Modified Ashworth Scale (MAS) scores of 1-2).
3. first stroke.
4. 0-12 months evolution.
5. no previous BTX-A or DN treatment for spasticity.
6. ankle passive range of motion ≥ 20° (approximately) with knee flexion \~30°.
7. independent ambulation with or without aids.

Exclusion Criteria:

1. medical conditions interfering with data interpretation.
2. contraindications for BTX-A or DN treatment.
3. changes in anti-spasticity medication dosage (if appropriate), either during the trial or within the 3 months prior to participation.
4. pregnant or breastfeeding.

Where it's running

• Universiteit Antwerpen
  Antwerp, Flanders, Belgium Recruiting
• Jewish Rehabilitation Hospital
  Montreal, Quebec, Canada Recruiting
• Hospital Clínico Universitario Lozano Blesa
  Zaragoza, Zaragoza, Spain Recruiting

Study contacts

• Principal investigator: Pablo Herrero Gallego, PhD — Universidad de Zaragoza
• Study coordinator: Pablo Herrero Gallego, PhD
• Email: pherrero@unizar.es
• Phone: +34646168248

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Deep phenotyping to explore recovery in young adults after stroke

  This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.

  Recruiting The Florey Institute of Neuroscience and Mental Health · Heidelberg, Victoria and 1 other locations · NCT07019493

• Stem cell therapy for chronic stroke recovery

  This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.

  Recruiting Phase 2 Hokkaido University Hospital · Sapporo, Hokkaido · NCT06752720

• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

  This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.

  Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

• Web-based therapy using action observation and mirror therapy for arm weakness after stroke

  This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.

  Recruiting Chang Gung Memorial Hospital · Taoyuan · NCT07921108

• Remote Ischaemic Conditioning for Fatigue After Stroke 2

  Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.

  Recruiting Phase 2 Sheffield Teaching Hospitals NHS Foundation Trust · Sheffield, South Yorkshire · NCT07914647

• Dual-task balance training plus computer-based cognitive training after stroke

  In adults who recently had a stroke, the study tests whether adding computerized cognitive exercises to balance training improves balance and other recovery outcomes.

  Recruiting Matia Foundation · San Sebastián, GUIPUZCOA · NCT07913620

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.