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First European Patients Enrolled in Largest Ever Randomised Controlled Trial of ITB Therapy(R) in Post-Stroke Patients With Severe Spasticity
Date:3/23/2010

has the potential to restore quality of life in patients whose lives have been completely disrupted by a stroke and the impairing and debilitating symptoms of spasticity," commented Professor Leopold Saltuari (LKH Hochzirl, Austria), global lead investigator of the SISTERS study. "With this study we are aiming to demonstrate that there is a way to manage spasticity for many of them."

The SISTERS study is an international trial, conducted in 20 sites in Europe and the US, including European centres in Austria, Belgium, Germany, Italy, the Netherlands, Spain, and the United Kingdom. The primary endpoint is the reduction of spasticity after six months of treatment with ITB Therapy and physical therapy compared to patients treated with one or more oral medications and physical therapy. Assessments include a 10-meter timed walking test, other functionality and independence tests, goal attainment scale, pain measurement, treatment satisfaction, quality of life, and safety aspects (adverse events).

In several clinical trials to date, ITB Therapy has been shown to provide a positive impact on the lives of post-stroke patients by reducing spasticity and increasing quality of life .[8,10] In other trials, 89 percent of patients
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SOURCE Medtronic Inc.
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