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.
- Conditions
- Post-Stroke Chronic Upper Limb Spasticity
- Registration Number
- NCT05224349
- Lead Sponsor
- Ipsen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 121
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline of Disability Assessment Scale (DAS) score in Principle Target of Treatment (PTT) for the upper limb. At 12 weeks to 16 weeks after injection at Visit 1 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.
- Secondary Outcome Measures
Name Time Method Change from baseline of Spasticity Related Quality of Life Tool (SQoL-6D) At 12 weeks to 16 weeks 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.
Incidence of Adverse Events (AEs) Up to 32 weeks Incidence of Special Situations (SS) Up to 32 weeks Change from baseline of Modified Ashworth Scale (MAS) Primary Target Muscle Group (PTMG) At 12 weeks to 16 weeks 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.
Change from baseline of pain assessed with Visual Analogue Scale (VAS) At 12 weeks to 16 weeks Pain (from 0 (no pain) to 10 (maximum pain) in upper limb extremity will be assessed at each visit.
Trial Locations
- Locations (30)
Nervenarztpraxis
🇩🇪Altdorf, Germany
Herford; Klinikum Herford
🇩🇪Herford, Germany
Neurologisches Zentrum
🇩🇪Berlin, Germany
Neurozentrum Erding
🇩🇪Erding, Germany
Praxis für Neurochirurgie und Schmerztherapie
🇩🇪Essen, Germany
Fürth; Medzentrum Fürth (MVZ)
🇩🇪Fürth, Germany
Neuropraxis Fuerth
🇩🇪Fürth, Germany
Neuropraxis Fürth
🇩🇪Fürth, Germany
Evangelisches Klinikum Gelsenkirchen GmbH
🇩🇪Gelsenkirchen, Germany
Universitätsmedizin Greifswald
🇩🇪Greifswald, Germany
Praxis Sojka-Raytscheff
🇩🇪Kiel, Germany
Neurologie am Funkerberg
🇩🇪Königs Wusterhausen, Germany
MVZ Lakumed gGMBH
🇩🇪Landshut, Germany
Praxis
🇩🇪Sonneberg, Germany
Fuerth; Medzentrum Fuerth
🇩🇪Ludwigsburg, Germany
UK Schleswig-Holstein Campus Lübeck
🇩🇪Lübeck, Germany
Neuropraxis Mannheim
🇩🇪Mannheim, Germany
Neurozentrum Arabellapark
🇩🇪München, Germany
Nürnberg; Praxis
🇩🇪Nuremberg, Germany
ABC Ambulantes BehandlungsCentrum GmbH
🇩🇪Nürnberg, Germany
ABC Moegeldorf
🇩🇪Nürnberg, Germany
Gesundheitszentrum Quickborn
🇩🇪Quickborn, Germany
Medicum. tegernsee - Rottach-Weissach
🇩🇪Rottach-Egern, Germany
Medicum. Tegernsee
🇩🇪Rottach, Germany
ZNS Südpfalz
🇩🇪Rülzheim, Germany
St. Lukas Klinik GmbH
🇩🇪Solingen, Germany
Stadtroda; Asklepios Fachklinikum Stadtroda
🇩🇪Stadtroda, Germany
Gemeinschaftspraxis
🇩🇪Straubing, Germany
MVZ Neurologie am St. Johannes Sieglar
🇩🇪Troisdorf, Germany
Neurologie im Denkmal
🇩🇪Wülfrath, Germany