Contemporary Clinical Trials Communications (Aug 2016)
Study of the effectiveness of hippotherapy on the symptoms of multiple sclerosis – Outline of a randomised controlled multicentre study (MS-HIPPO)
Abstract
Background: Hippotherapy is a form of therapeutic riding which is used in the treatment of neurological and muscular disorders. Until now there has not been any high-quality randomised study that has proven its effectiveness. Objective: The aims of this study are to evaluate whether hippotherapy (as add-on to physiotherapy and/or pharmacotherapy) is superior to the standard treatment (physiotherapy and/or pharmacotherapy as prior to the study) in terms of balance function and other patient relevant outcomes in patients with multiple sclerosis. Methods: The MS-HIPPO study is a prospective, randomised, examiner-blinded, controlled multicentre study. Patients were randomised to one of two groups: 12 weeks of hippotherapy accompanied by physiotherapy and/or pharmacotherapy (intervention) or 12 weeks of physiotherapy and/or pharmacotherapy as prior to the study (control). The primary endpoint is the change in balance function, as measured by the Berg Balance Scale (BBS). The treatment comparison is evaluated using a covariance analysis with baseline BBS, centre, age, gender and EDSS as covariates. Secondary endpoints include fatigue, quality of life, pain intensity and spasticity. Results and conclusions: The described study is the first randomised study evaluating the benefits of hippotherapy for patients with multiple sclerosis. In 5 national centres ten study physicians will screen potential participants. The expected results will help to improve the knowledge on non-pharmaceutical therapeutic options in this field.
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