Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity
NCT ID: NCT06296082
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
90 participants
INTERVENTIONAL
2024-09-01
2025-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Botulinum Toxin type A
The BTX-A group will receive onabotulinumtoxinA (Botox®, Allergan) with mandatory muscles getting 300 units and optional muscles getting up to 100 additional units (maximum dose of 400 units) (14) delivered with a 27-gauge (0.45 mm) beveled needle. Target muscles will be identified by ultrasound imaging or muscle stimulation. Local anesthesia will not be used. Patient positioning will be standardized.
Botulinum 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.
Dry Needling
For Dry Needling group solid, filiform non-beveled 0.30 mm caliber needles will be used. Target muscles will be identified by ultrasound imaging or muscle stimulation. Local anesthesia will not be used. Patient positioning will be standardized.
Dry 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.
Interventions
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Botulinum 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.
Dry 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Instituto de Investigación Sanitaria Aragón
OTHER
McGill University
OTHER
Instituto de Salud Carlos III
OTHER_GOV
Fonds de la Recherche en Santé du Québec
OTHER_GOV
Research Foundation Flanders
OTHER
Universiteit Antwerpen
OTHER
Responsible Party
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Dr. Pablo Herrero Gallego
Prof. Dr.
Principal Investigators
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Pablo Herrero Gallego, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de Zaragoza
Locations
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Universiteit Antwerpen
Antwerp, Flanders, Belgium
Jewish Rehabilitation Hospital
Montreal, Quebec, Canada
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Zaragoza, Spain
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Web site of the project.
Other Identifiers
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49317
Identifier Type: -
Identifier Source: org_study_id
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