Phase
Condition
Stroke
Limb Spasticity
Cerebral Ischemia
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 atleast 6 months. Medium to severe focal upper limb spasticity is defined as MAS ≥2 inthe PTMG and DAS ≥2 in the PTT.
Cohort according to SMART guidelines. The SMART injection concept is designed to beused only in patients suffering from simple patterns ("easy to diagnose spasticitypattern") of adult ULS, where Abobotulinumtoxin-A (AboBoNT-A) (Dysport®) injectioncan be simplified, by recognizing common spasticity patterns and key muscles forinjection, identifying those muscles by palpation, and appropriate injection pointsof 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 currentlocal Summary of Product Characteristics (SmPC) (Germany) and injection according toSMART must be taken prior to the entry in the study.
Physiotherapy should remain unchanged within 4 weeks before study start.
Exclusion
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 medicationwithin the last 4 weeks
Patients with active hand functions or patients with treatment goals of activefunctions.
Patients with any contraindication for Dysport® according to SmPC.
Patients in whom SMART therapy is not appropriate (e.g. spasticity pattern otherthan specified in SMART guidelines).
Participation in an interventional trial at the same time and/or within 3 monthsbefore baseline.
Diagnosed contracture/contracted muscle.
Study Design
Connect with a study center
Nervenarztpraxis
Altdorf,
GermanySite Not Available
Neurologisches Zentrum
Berlin,
GermanySite Not Available
Neurozentrum Erding
Erding,
GermanySite Not Available
Praxis für Neurochirurgie und Schmerztherapie
Essen,
GermanySite Not Available
Fürth; Medzentrum Fürth (MVZ)
Fürth,
GermanySite Not Available
Neuropraxis Fuerth
Fürth,
GermanySite Not Available
Neuropraxis Fürth
Fürth,
GermanySite Not Available
Evangelisches Klinikum Gelsenkirchen GmbH
Gelsenkirchen,
GermanySite Not Available
Universitätsmedizin Greifswald
Greifswald,
GermanySite Not Available
Herford; Klinikum Herford
Herford,
GermanySite Not Available
Praxis Sojka-Raytscheff
Kiel,
GermanySite Not Available
Neurologie am Funkerberg
Königs Wusterhausen,
GermanySite Not Available
MVZ Lakumed gGMBH
Landshut,
GermanySite Not Available
Praxis
Leipzig,
GermanySite Not Available
Fuerth; Medzentrum Fuerth
Ludwigsburg,
GermanySite Not Available
UK Schleswig-Holstein Campus Lübeck
Lübeck,
GermanySite Not Available
Neuropraxis Mannheim
Mannheim,
GermanySite Not Available
Neurozentrum Arabellapark
München,
GermanySite Not Available
Praxis
München,
GermanySite Not Available
Nürnberg; Praxis
Nuremberg,
GermanySite Not Available
ABC Ambulantes BehandlungsCentrum GmbH
Nürnberg,
GermanySite Not Available
ABC Moegeldorf
Nürnberg,
GermanySite Not Available
Gesundheitszentrum Quickborn
Quickborn,
GermanySite Not Available
Medicum. Tegernsee
Rottach,
GermanySite Not Available
Medicum. tegernsee - Rottach-Weissach
Rottach-Egern,
GermanySite Not Available
Medicum. tegernsee
Rottach-Weissach,
GermanySite Not Available
ZNS Südpfalz
Rülzheim,
GermanySite Not Available
St. Lukas Klinik GmbH
Solingen,
GermanySite Not Available
Praxis
Sonneberg,
GermanySite Not Available
Stadtroda; Asklepios Fachklinikum Stadtroda
Stadtroda,
GermanySite Not Available
Gemeinschaftspraxis
Straubing,
GermanySite Not Available
MVZ Neurologie am St. Johannes Sieglar
Troisdorf,
GermanySite Not Available
Neurologie im Denkmal
Wuelfrath,
GermanySite Not Available
Neurologie im Denkmal
Wülfrath,
GermanySite Not Available
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