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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

302 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2018-02-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Post-stroke Arm Spasticity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Botulinum toxin type A (BoNT-A) injection (Dysport®) Naïve

Subjects naïve to BoNT-A treatment.

No interventions assigned to this group

Botulinum toxin type A (BoNT-A) Pre-treated

Subjects pre-treated with BoNT-A.

Investigators follow their individual injection protocol for the treatment with BoNT-A (modalities of administration in accordance with local Summary of Product Characteristics \[SmPC\]).

No interventions assigned to this group

Eligibility Criteria

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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