Study on the Use of Botulinum Toxin Type A in the Treatment of Chronic Post-stroke Spastic Patients "B-CAUSE"

Completed

Phase N/A Results N/A

Trial Description

The purpose of this study is to document the effectiveness of treating chronic post-stroke spastic patients with Botulinum Toxin type A.

Detailed Description

As this is a non-interventional study, the decision to prescribe the product must be taken prior to, and independently from the decision to enrol the patient. This decision should be made in accordance with routine clinical practice at the hospital concerned. The clinical justification for prescribing any treatment should be recorded at the outset by the prescribing clinician.
This study will not interfere with the routine practice of the investigator or with the patient's treatment plan. Assessments will be done only if performed regularly in routine practice.
This study will be conducted in Brazil, wherein Marketing Authorization has been granted for the use of BoNT-A in the treatment of spasticity of the upper and lower limb in adult post-stroke patients.

Conditions

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Untreated chronic post-stroke spastic patients

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Goal Achievement Score (GAS). 3 and 6 months No
Secondary Change from baseline in pain according to Verbal Numerical Scale (VNS). Baseline and 3 months No
Secondary Change from baseline in Modified Ashworth Scale (MAS) score Baseline and 3 months No
Secondary Change from baseline in functional independence according to Barthel index score Baseline and 3 months No
Secondary Change from baseline in Quality of Life according to Euro-5D-5L health questionnaire Baseline and 3 months No

Sponsors