Arm Spasticity - Non-Interventional Study Early BIRD (BoNT Treatment: Initial and Repeated Documentation)

Ipsen302 enrolled

Overview

Botulinum toxin A (BoNT-A) is effective and safe in alleviating post-stroke spasticity and reducing the burden of associated symptoms. The hypothesis for this non-interventional study in arm spasticity (AS-NIS early BIRD) is no significant difference between naïve and pre-treated patients. The patients will be divided in sub-groups according to the time interval between occurrence of stroke and start of treatment (early, medium and late start of treatment according to the first and third quartiles time distribution). It is hypothesized that the "early" start of treatment group will have a reduced modified Ashworth scale (MAS) on the elbow and wrist flexors when compared to the "late" start of treatment group.

Study Type

OBSERVATIONAL

Enrollment

302

Conditions

Post-stroke Arm Spasticity

Eligibility

Sex: ALLMin age: 25 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent prior to data collection * Hemiparesis and clinically relevant upper limb post-stroke spasticity * Treated with Dysport® or with the intention to be treated with Dysport® according to local SmPC * BoNT naïve or pre-treated with any BoNT product Exclusion Criteria: * Recurrent stroke * Sensitivity to Dysport® or to its excipients or any other contraindications as given in the local SmPC for Dysport®

Locations (5)

Unnamed facility

Hermagor, Austria

Unnamed facility

Bidart, France

Unnamed facility

Berlin, Germany

Unnamed facility

Zwolle, Netherlands

Unnamed facility

Bern, Switzerland

Outcomes

Primary Outcomes

Comparison of modified Ashworth scale (MAS) between patients with early start of treatment and patients with late start of treatment in the overall population (naive and pre-treated).

"Early" and "late" start of treatment according to the first and third quartiles time distribution between stroke and start of treatment with BoNT-A. Investigation of effectiveness of BoNT-A treatment on the evolution of spasticity using MAS (sum of elbow and wrist flexors, EWF).

Time frame: Final study visit: approximately 20 months after first visit

Secondary Outcomes

Comparison of modified Ashworth scale (MAS) between patients with early start of treatment and patients with late start of treatment in the overall population (naive and pre-treated).

Time frame: Approximately every 4 months starting from baseline up to 2 years