# Effectiveness of hippotherapy on balance performance, neurophysiological parameters and clinical symptoms of multiple sclerosis: Study protocol of a randomized controlled multicenter study (MS-HIPPO II - Movement in Balance)

## TL;DR

This study tests if hippotherapy improves balance and symptoms in multiple sclerosis patients compared to usual care.

## Contribution

The study introduces a multicenter randomized controlled trial to evaluate hippotherapy's effectiveness in MS.

## Key findings

- Hippotherapy's impact on balance will be measured using standardized clinical and sensorimotor tools.
- Neurophysiological changes during balance tasks will be assessed via EEG.
- Secondary outcomes like fatigue and quality of life will be evaluated alongside balance improvements.

## Abstract

Exercise and physical therapy have been shown to be effective in the non-pharmacological symptomatic treatment of multiple sclerosis (MS). Hippotherapy as an additive physical therapy intervention is applied in this study to promote balance and postural control, since the number of sufficiently high-quality randomized controlled trials indicating its effectiveness is limited.

This study aims to provide more in-depth insights into the effectiveness of hippotherapy in MS in terms of balance and other patient-relevant outcomes, building on the results of a preliminary study (MS-HIPPO II, evidence level 1b).

Based on a prospective, randomized, investigator-blinded, controlled multicenter study design, the primary endpoint of differences in balance will be investigated. Patients will be randomized to an intervention group (12 weeks of hippotherapy) or a control group (12 weeks of treatment as usual). Balance will be measured using the Berg Balance Scale (BBS) plus a standardized balance task on a force plate (AccuGait-Optimized, Advanced Mechanical Technology, Inc., Massachusetts, US) and a balance perturbation task on an oscillating sensorimotor therapy device (Bioswing Posturomed®, Haider, Pullenreuth, Germany). During balance tasks, electrocortical activity will be investigated using electroencephalography (EEG) (LiveAmp 32, Brain Products GmbH, Gilching, Germany). Secondary endpoints include fatigue (FSS), quality of life (MSQoL-54), pain (VAS), spasticity (NRS) and participation (WHODAS 2.0). Therapy progress will be documented via an ICF-based hippotherapy assessment-tool (EQUITEDO®, Frechen, Germany).

The results should contribute to improve the understanding of non-pharmaceutical treatment options in the field of exercise and movement therapy in MS.

The trial was registered at March 05, 2024 in the German Clinical Trial Register under DRKS00033449.