RecruitingPhase 2Phase 3NCT06296082

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

Sponsor

Universiteit Antwerpen

Enrollment

90 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Stroke

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

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 Criteria4

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.

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Interventions

DRUGBotulinum toxin type A

Botulinum toxin type A injections are a treatment technique to treat the spastic muscles in patients with stroke that targets on the neuromuscular endplate zone provoking a chimical disruption of dysfunctional endplates.

OTHERDry Needling

Dry Needling is a treatment technique to treat the spastic muscles in patients with stroke that targets on the neuromuscular endplate zone provoking a mechanical disruption of dysfunctional endplates.