Overview
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.
Description
The primary hypothesis is that the effects of DN on post-stroke spasticity in the lower limbs at the spinal level is comparable to BTX-A in reducing spasticity by decreasing stretch reflex excitability.
Sample size: Spain, Canada and Belgium will recruit 90 participants (30 per country)
The platform used for randomization and electronic data collection will be Research Electronic Data Capture (REDcap): https://www.project-redcap.org/. A shared license will be used among the countries involved in the study.
Data dictionary:
- DN: Dry Needling
- BTX-A: Botulinum toxin type A
- TSRT: Tonic Stretch Reflex Threshold
- MAS: Modified Ashworth Scale
- 10MWT: 10 Metre Walk Test
- TUG: Timed Up \& Go
- PPI: Public and Patient Involvement
- SOP: Standard Operating Procedure
Eligibility
Inclusion 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.
Exclusion Criteria:
- 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.
