A Prospective, Non-interventional Survey to Evaluate Injection Intervals and Treatment Modalities of Botulinum Toxin A (BoNT-A) in Adult Patients Suffering From Upper Limb Spasticity After Stroke

A National, Prospective, Non-interventional Survey to Evaluate Injection Intervals and Treatment Modalities up to 3 Years Follow up of Botulinum Toxin A in Adult Subjects Suffering From Upper Limb Spasticity Post-CVA (Cerebrovascular Accident)

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01239628

Acronym

DECIDE

Enrollment

Registered

2010-11-11

Start date

2010-12-31

Completion date

2015-12-31

Last updated

2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Limb Spasticity After Stroke

Brief summary

The purpose of the protocol is to evaluate injection intervals and treatment modalities up to 3 years follow-up of botulinum toxin A (BoNT-A) in adult patients suffering from upper limb spasticity after stroke.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject able to comply with the protocol * Provision of written informed consent prior to collecting the data * Male or female patients of 18 years or older * Presenting with upper limb spasticity after stroke for which treatment with botulinum toxin A is indicated

Exclusion criteria

* The subject has already been included in this survey * Patients who already received BoNT-A treatment for upper limb spasticity * Patients with known intolerance for BoNT-A * Subjects unable to comply with the protocol

Design outcomes

Primary

Measure	Time frame
Documentation of the injection intervals	3 years
Documentation of treatment modalities	3 years

Secondary

Measure	Time frame
Documentation of the main reason(s) for change in injection intervals	3 years
Documentation of the main reason(s) for dose change(s)	3 years
Documentation of the patient satisfaction with the treatment	3 years
Documentation of the physician satisfaction with the treatment	3 years

Countries

Belgium

Outcome results