Actively Recruiting
Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity
Led by Universiteit Antwerpen · Updated on 2026-05-04
90
Participants Needed
3
Research Sites
134 weeks
Total Duration
On this page
Sponsors
U
Universiteit Antwerpen
Lead Sponsor
I
Instituto de Investigación Sanitaria Aragón
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a randomized parallel group clinical trial which will be conducted in three countries (Spain, Canada and Belgium) comparing Botulinum Toxin type A (BTX-A) and Dry Needling (DN) effectiveness for post-stroke spasticity in participants who had a first stroke in the previous 12 months and have plantar flexor spasticity. Participants will be randomly allocated to receive either one session of BTX-A or 12 weekly sessions of DN. Blinded evaluators will assess the effects before, during, and after treatment, and at a 4-week follow-up.
CONDITIONS
Official Title
Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Post-stroke spasticity in ankle plantar flexors with Modified Ashworth Scale scores of 1-2
- First stroke occurrence
- Stroke happened within the past 12 months
- No previous treatment with Botulinum Toxin type A or Dry Needling for spasticity
- Ankle passive range of motion of approximately 20 degrees or more with knee flexed about 30 degrees
- Ability to walk independently with or without aids
You will not qualify if you...
- Medical conditions that interfere with interpreting study data
- Contraindications to Botulinum Toxin type A or Dry Needling treatments
- Changes in anti-spasticity medication dosage during the trial or within 3 months before participation
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Universiteit Antwerpen
Antwerp, Flanders, Belgium, 2000
Actively Recruiting
2
Jewish Rehabilitation Hospital
Montreal, Quebec, Canada, H7V 1R2
Actively Recruiting
3
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Zaragoza, Spain, 50009
Actively Recruiting
Research Team
P
Pablo Herrero Gallego, PhD
CONTACT
C
Clara Pujol Fuentes, Msc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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