NCT06296082RecruitingPhase 2/3
Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity
Comparative Study of the Mechanism of Action of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity: a Proof of Concept Controlled Trial
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 13 Feb 2024
- Start date
- 1 Sept 2024
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Universiteit Antwerpen
- Diseases
- Stroke
- NCT number
- NCT06296082
- EU CT number
- 2024-510866-18-00
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 90
- From 1 Sept 2024 to the primary completion date, 30 Dec 2026
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- changes in anti-spasticity medication dosage (if appropriate), either during the trial or within the 3 months prior to participation.
Other illness
- medical conditions interfering with data interpretation.
Other
- contraindications for BTX-A or DN treatment.
- pregnant or breastfeeding.
Who the study is looking for
- aged 18-75 years.
- post-stroke spasticity in ankle plantar flexors (Modified Ashworth Scale (MAS) scores of 1-2).
- first stroke.
- 0-12 months evolution.
- no previous BTX-A or DN treatment for spasticity.
- ankle passive range of motion ≥ 20° (approximately) with knee flexion \~30°.
- independent ambulation with or without aids.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emmaues Coordinator of this site? Confirm its status | Malle | Belgium | Recruiting |
| Jewish Rehabilitation Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Fundacion Instituto De Investigacion Sanitaria Aragon Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.