Effectiveness and Safety of SMART [Spastic Muscle Palpation by Anatomic Landscape for BoNT-A (Botulinumtoxin-A) Injection to Reduce Muscle Tone] BoNT-A Therapy With Dysport® in Patients With Post-stroke Chronic Upper Limb Spasticity (ULS) in Real-life Setting.

Study Overview
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Brief Summary
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The purpose of this study is to collect data for Dysport® SMART BoNT-A therapy usage in an office-based setting in post-stroke participants with chronic (> 6 months) focal Upper Limb Spasticity who have been under stable oral antispastics treatment or patients with no current anti-spasticity treatment.

Official Title
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Effectiveness and Safety of SMART BoNT-A Therapy With Dysport® in Patients With Post-stroke Chronic Upper Limb Spasticity in Real-life Setting.

Conditions
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Post-Stroke Chronic Upper Limb Spasticity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients ≥18 years with the capacity to consent. Subjects with a post-stroke medium to severe focal upper limb spasticity for at least 6 months. Medium to severe focal upper limb spasticity is defined as MAS ≥2 in the PTMG and DAS ≥2 in the PTT. Cohort according to SMART guidelines. The SMART injection concept is designed to be used only in patients suffering from simple patterns (easy to diagnose spasticity pattern) of adult ULS, where Abobotulinumtoxin-A (AboBoNT-A) (Dysport®) injection can be simplified, by recognizing common spasticity patterns and key muscles for injection, identifying those muscles by palpation, and appropriate injection points of the suggested muscles using anatomic landmarks. Subjects with treatment goals as reduction of pain, reduction of muscle tone, improvement of care (hygiene/dressing) and/or improvement of passive motion. Subjects with the intention to be treated with Dysport® according to the current local Summary of Product Characteristics (SmPC) (Germany) and injection according to SMART must be taken prior to the entry in the study. Physiotherapy should remain unchanged within 4 weeks before study start. Exclusion Criteria: Patients treated with intrathecal Baclofen or BoNT-A within the last 6 months If treated with oral spasticity medication, change of oral spasticity medication within the last 4 weeks Patients with active hand functions or patients with treatment goals of active functions. Patients with any contraindication for Dysport® according to SmPC. Patients in whom SMART therapy is not appropriate (e.g. spasticity pattern other than specified in SMART guidelines). Participation in an interventional trial at the same time and/or within 3 months before baseline. Diagnosed contracture/contracted muscle.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Participants with stable oral anti-spasticity treatment for at least 4 weeks prior to study entry | |
| Group B<br>Participants with no anti-spasticity therapy for at least 4 weeks prior to study entry | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Disability Assessment Scale (DAS) score in Principle Target of Treatment (PTT) for the upper limb. | The PTT will be pre-selected from the 4 DAS domains: hygiene, dressing, limb position and pain of the upper limb at Visit 1. The extent of functional impairment in the PTT will be assessed on a four-point scale (range 0 to 3, where 0=no disability, and 3=severe disability) at each visit. | At 12 weeks to 16 weeks after injection at Visit 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Modified Ashworth Scale (MAS) Primary Target Muscle Group (PTMG) | Muscle tone will be evaluated using the MAS. The PTMG (shoulder adductors, elbow flexors, wrist flexors or finger flexors) will be pre-selected at Visit 1. The muscle tone in the PTMG will be assessed from 0 (no increase in tone) to 4 (affected part(s) rigid in flexion or extension) at each visit. | At 12 weeks to 16 weeks | 
| Change from baseline of pain assessed with Visual Analogue Scale (VAS) | Pain (from 0 (no pain) to 10 (maximum pain) in upper limb extremity will be assessed at each visit. | At 12 weeks to 16 weeks | 
| Change from baseline of Spasticity Related Quality of Life Tool (SQoL-6D) | The questionnaire covers six dimensions: Pain/ discomfort, involuntary movement or spasms, restricted range of movement, caring for the affected limb, using the affected limb, mobility/balance. Each dimension is assessed using a five-point scale ranging from 0 to 4, with higher scores meaning worse outcome. | At 12 weeks to 16 weeks | 
| Incidence of Adverse Events (AEs) |  | Up to 32 weeks | 
| Incidence of Special Situations (SS) |  | Up to 32 weeks |