Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity
Launched by UNIVERSITEIT ANTWERPEN · Feb 28, 2024
Trial Information
Current as of August 20, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different treatments for people who have spasticity in their lower limbs after having a stroke. Spasticity is a condition where muscles become stiff and hard to move, which can affect walking and daily activities. The researchers want to compare the effects of Botulinum Toxin Type A (BTX-A), which is an injection that relaxes muscles, to Dry Needling (DN), a technique that involves inserting thin needles into specific muscle points to relieve tension. Participants will be randomly assigned to receive either one session of BTX-A or 12 weekly sessions of DN, and their progress will be monitored by evaluators who do not know which treatment each person received.
To join this study, participants need to be between 18 and 75 years old and must have had their first stroke within the last year, resulting in moderate spasticity in their ankle muscles. They should be able to walk independently, with or without assistance. Throughout the trial, participants can expect evaluations before, during, and after their treatment, including a follow-up about four weeks later. It’s important to note that individuals with certain medical conditions or those who are pregnant or breastfeeding cannot participate. This trial is taking place in Spain, Canada, and Belgium and is currently recruiting participants.
Gender
ALL
Eligibility criteria
- 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.
About Universiteit Antwerpen
The University of Antwerp is a leading research institution based in Belgium, renowned for its commitment to advancing knowledge and innovation in various scientific fields. With a strong emphasis on interdisciplinary collaboration, the university actively engages in clinical trials that aim to improve healthcare outcomes and enhance understanding of complex medical conditions. The University of Antwerp's dedicated research teams leverage cutting-edge methodologies and state-of-the-art facilities to conduct rigorous studies, ensuring adherence to the highest ethical standards and regulatory requirements. Through its clinical trial initiatives, the university strives to translate research findings into practical applications that benefit patients and contribute to the broader medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Zaragoza, , Spain
Antwerpen, Flandes, Belgium
Montréal, Quebec, Canada
Patients applied
Trial Officials
Pablo Herrero Gallego, PhD
Principal Investigator
Universidad de Zaragoza
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported