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.

NCT ID: NCT05224349

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 121 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-09
• Study Completion Date: 2025-07-04

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.

Conditions

Post-Stroke Chronic Upper Limb Spasticity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

Participants with stable oral anti-spasticity treatment for at least 4 weeks prior to study entry

No interventions assigned to this group

Group B

Participants with no anti-spasticity therapy for at least 4 weeks prior to study entry

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Nervenarztpraxis

Altdorf, , 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

Herford; Klinikum Herford

Herford, , Germany

Praxis Sojka-Raytscheff

Kiel, , Germany

Neurologie am Funkerberg

Königs Wusterhausen, , Germany

MVZ Lakumed gGMBH

Landshut, , Germany

Praxis

Leipzig, , Germany

Fuerth; Medzentrum Fuerth

Ludwigsburg, , Germany

UK Schleswig-Holstein Campus Lübeck

Lübeck, , Germany

Neuropraxis Mannheim

Mannheim, , Germany

Neurozentrum Arabellapark

München, , Germany

ABC Ambulantes BehandlungsCentrum GmbH

Nuremberg, , Germany

ABC Moegeldorf

Nuremberg, , Germany

Nürnberg; Praxis

Nuremberg, , Germany

Gesundheitszentrum Quickborn

Quickborn, , Germany

Medicum. Tegernsee

Rottach, , Germany

Medicum. tegernsee - Rottach-Weissach

Rottach-Egern, , Germany

ZNS Südpfalz

Rülzheim, , Germany

St. Lukas Klinik GmbH

Solingen, , Germany

Praxis

Sonneberg, , Germany

Stadtroda; Asklepios Fachklinikum Stadtroda

Stadtroda, , Germany

Gemeinschaftspraxis

Straubing, , Germany

MVZ Neurologie am St. Johannes Sieglar

Troisdorf, , Germany

Neurologie im Denkmal

Wuelfrath, , Germany

Countries

Germany

Other Identifiers

EUPAS107722

Identifier Type: OTHER

Identifier Source: secondary_id

CLIN-52120-456

Identifier Type: -

Identifier Source: org_study_id