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New treatment option for Stroke
Official title Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity
ClinicalTrials.gov ID: NCT06296082
What this study is testing
What is Botulinum toxin type A?
Botulinum toxin type A is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- medical conditions interfering with data interpretation.
- contraindications for BTX-A or DN treatment.
- changes in anti-spasticity medication dosage (if appropriate), either during the trial or within the 3 months prior to participation.
- pregnant or breastfeeding.
See the full eligibility criteria
- 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.
- medical conditions interfering with data interpretation.
- contraindications for BTX-A or DN treatment.
- changes in anti-spasticity medication dosage (if appropriate), either during the trial or within the 3 months prior to participation.
- pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Antwerp, Flanders, Belgium
- Montreal, Quebec, Canada
- Zaragoza, Zaragoza, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Antwerp, Flanders, Belgium; Montreal, Quebec, Canada; Zaragoza, Zaragoza, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.