Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type a As a Treatment for Lower Limb Post-stroke Spasticity
StrokeThis 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.
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
18 to 75
Critères de participation
Inclusion Criteria:
1. aged 18-75 years.
2. post-stroke spasticity in ankle plantar flexors (Modified Ashworth Scale (MAS) scores of 1-2).
3. first stroke.
4. 0-12 months evolution.
5. no previous BTX-A or DN treatment for spasticity.
6. ankle passive range of motion ≥ 20° (approximately) with knee flexion \~30°.
7. independent ambulation with or without aids.
Exclusion Criteria:
1. medical conditions interfering with data interpretation.
2. contraindications for BTX-A or DN treatment.
3. changes in anti-spasticity medication dosage (if appropriate), either during the trial or within the 3 months prior to participation.
4. pregnant or breastfeeding.
Lieu de l'étude
Jewish Rehabilitation Hospital
Jewish Rehabilitation HospitalMontréal, Quebec
Canada
Contactez l'équipe d'étude
- Étude parrainée par
- Universiteit Antwerpen
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT06296082