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: * 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
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 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.
Universiteit Antwerpen
Antwerp, Flanders, Belgium
RECRUITINGJewish Rehabilitation Hospital
Montreal, Quebec, Canada
RECRUITINGHospital Clínico Universitario Lozano Blesa
Zaragoza, Zaragoza, Spain
RECRUITINGTonic 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.
Time frame: Week 1 to 15 and 19.
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.
Time frame: Week 1 to 15 and 19.
Pennation angle
It is the angle between the deep fascia and the line of the fascicle length.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 1,2,9,15 and 19
Functional mobility
Measured by Time Up and Go (TUG).
Time frame: Week 1,2,9,15 and 19
Functional mobility
Measured by 10 Meter Walk Test (10MWT)
Time frame: Week 1,2,9,15 and 19
Muscle Strength
Muscle strength will be measured by hand-held dynamometry (MicroFET 2)
Time frame: 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.
Time frame: 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)
Time frame: Week 19.
Safety: Frequency and severity of Dry Needling (DN) and Botulinum Toxin type A (BTX-A) adverse events
Description of the adverse events
Time frame: Week 3 to 14 and 19.
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