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| Name | Class |
|---|---|
| Instituto de Investigación Sanitaria Aragón | OTHER |
| McGill University | OTHER |
| Instituto de Salud Carlos III | OTHER_GOV |
| Fonds de la Recherche en Santé du Québec |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum Toxin type A | Active Comparator | 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. |
|
| Dry Needling | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tonic Stretch Reflex Threshold (TSRT) | TSRT is a novel measures of stretch reflex excitability that provide an indirect indicator of the excitability of α-motoneurons at the level of the spinal cord. | Week 1 to 15 and 19. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle thickness | It is the estimation of the thickness of the muscle fiber, which is obtained by tracing a line that covers the length of the muscle between the deep and superficial aponeuroses. | Week 1 to 15 and 19. |
| Pennation angle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pablo Herrero Gallego, PhD | Contact | +34646168248 | pherrero@unizar.es | |
| Clara Pujol Fuentes, Msc | Contact | +34661075990 | clara.pujol.fisioterapeuta@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pablo Herrero Gallego, PhD | Universidad de Zaragoza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiteit Antwerpen | Recruiting | Antwerp | Flanders | 2000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42160369 | Derived | Pujol-Fuentes C, Eeckhaut B, Fernandez Carnero S, Fernandez Sanchis D, Wein T, Herrero P, Saeys W, Levin MF. Spinal mechanisms and feasibility of Dry Needling versus Botulinum Toxin Type A in post-stroke lower limb spasticity: A proof-of-concept randomized clinical trial protocol (STROKE-POC). PLoS One. 2026 May 20;21(5):e0334571. doi: 10.1371/journal.pone.0334571. eCollection 2026. |
| Label | URL |
|---|---|
| Web site of the project. | View source |
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Individual participant data (IPD) will be shared with other researchers in accordance with data sharing protocols and participant consent, ensuring confidentiality and ethical considerations are maintained.
Data will be available for 15 years.
In relation to other academic institutions and in the possession of a Good Clinical Practice Certificate
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000079245 | Dry Needling |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| OTHER_GOV |
| Research Foundation Flanders | OTHER |
A prospective randomized, controlled, multiple-baseline, and assessor blinded multicenter equivalence trial with two parallel groups.
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Assessments will be conducted by blinded assessors for treatment allocation. Participants and staff cannot be blinded due to the nature of the intervention, but are instructed not to disclose their treatment allocation. Data will be anonymized and an independent researcher will enter coded data into secure databases. Data will be analyzed by a blinded statistician. Code breaks will only be allowed in crucial cases for patient management.
| Dry Needling | Other | 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. |
|
It is the angle between the deep fascia and the line of the fascicle length.
| Week 1 to 15 and 19. |
| Concurrence matrices | Measures that describe the spatial distribution of gray levels in the texture of an ultrasound image. These matrices, also known as co-occurrence matrices, are used to analyze textural features and patterns in ultrasound images. | Week 1 to 15 and 19. |
| Resistance to passive stretching | It will be measured using the Modified Ashworth Scale (MAS). The scale ranges from a minimum value of 0 to a maximum of 4, with 0 indicating no spasticity (no resistance to passive stretching) and 4 representing the most severe spasticity (resistance to passive stretching), characterized by complete rigidity. | Week 1 to 15 and 19. |
| Gait analysis | It will be done with motion capture systems using wearable and inertial sensors. Canada and Belgium: Xsens system (MVN Awinda, Movella, Hendersen, USA); Spain: Move Human Sensors MoCap System. | Week 1,2,9,15 and 19 |
| Functional mobility | Measured by Time Up and Go (TUG). | Week 1,2,9,15 and 19 |
| Functional mobility | Measured by 10 Meter Walk Test (10MWT) | Week 1,2,9,15 and 19 |
| Muscle Strength | Muscle strength will be measured by hand-held dynamometry (MicroFET 2) | Week 1 to 15 and 19. |
| Quality of life analysis | It will be assessed with the EuroQOL-5D (Euro Quality of Life-5 Dimensions-5 Levels). Responses from the questionnaire will be converted to health-state utility values, where higher values represent improved quality of life. Index scores range from -0.59 to 1, where 1 is the best possible health state. | Week 1, 15 and 19. |
| Cost-effectiveness | Costs related to treatment will be assessed by computing the ICER (Incremental cost-effectiveness ratio) in €/QALY (Quality-Adjusted Life Year) | Week 19. |
| Safety: Frequency and severity of Dry Needling (DN) and Botulinum Toxin type A (BTX-A) adverse events | Description of the adverse events | Week 3 to 14 and 19. |
| Jewish Rehabilitation Hospital | Recruiting | Montreal | Quebec | H7V 1R2 | Canada |
|
| Hospital Clínico Universitario Lozano Blesa | Recruiting | Zaragoza | Zaragoza | 50009 | Spain |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |