G35
Conditions
Interventions
Group 1: Hippotherapy in addition to physiotherapy: Within a project duration of two years and six months (01.01.2024 - 30.06.2026), a randomized controlled design will be used at 7 locations in Germa
Sponsors
Kamillus Klinik Asbach
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Confirmed multiple sclerosis with spasticity of the lower limbs EDSS score between 4 and 6 Written informed consent of the patient Consent of the study site neurologist Legal competency Minimum age of 18 years
Exclusion criteria
Exclusion criteria: Hippotherapy within the last 12 months Parallel participation in other intervention studies Persons who are in a dependent/employment relationship with the sponsor or investigator (potential conflict of interest) Body weight over 90 kg Acute exacerbation four weeks before the start of therapy No balance when sitting Planned start of treatment with new antispastic medication or with medication that may have an influence on test parameters (examples: Sativex®; neuraxial administration of baclofen; 4-aminopyridine) Seizure disorder not controlled by medication No or insufficient ability to spread the legs, so that the patient can sit on the horse Known severe osteoporosis Known severe osteoarthritis in the hip Known severe scoliosis that could be aggravated by hippotherapy Severe blood clotting disorders where there is a risk of haematoma due to hippotherapy Insufficiently stable concomitant diseases in the field of internal medicine, gynecology and/or surgery Allergy to horse hair Pregnancy Berg Balance Scale score over 50 points before the start of the intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Balance control: The primary endpoint of the study is the change in balance performance after 12 therapy sessions (change from baseline). The primary endpoint is a study consisting of various tasks performed on a force plate (AMTI Accu Gait Optimized (ACG-O)). In addition, test tasks are performed on an oscillating sensorimotor therapy device (Bioswing Posturomed®) to achieve balance from a previous balance disorder. The measurement is divided into 1) recording of static balance (standing, with eyes open and closed, close stance, (half) tandem stance, (half) one-legged stance) and 2) recording of static balance after previous dynamic balance ("achieving balance" with manual triggering of oscillating movements on the sensorimotor therapy device) (Bioswing, Haider). With regard to the achievement of postural stability, the CoP - postural sway (mm), as well as the reaction and latency time (ms) of the postural correction information from the start of movement of the platform and other parameters are now measured. In addition, electromyographic electrodes (EMG) are attached to the lower leg (soleus and tibialis anterior muscles) of the participants in order to evaluate muscle activity locally in relation to specific movement patterns. The balance measurements are combined with a parallel measurement of brain activity via an EEG measurement system (Brainvision, 32 System) to obtain further information on cortical activity related to postural control. By measuring the excitatory postsynaptic action potentials, a movement-induced change in brain activity in the frequency bands will be displayed, which will be analyzed with the Brain Vision Analyzer software. In addition to the measurement procedure described above, the Berg Balance Scale (BBS) will be used in an independent assessment by a blinded physiotherapist, which is the gold standard or established instrument for measuring balance and enables a comparison of the therapy results with other interventions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatigue, quality of life, pain, spasticity and participation: The secondary endpoints of the study are the measurement of fatigue using the Fatigue Severity Scale (FSS), which is the gold standard for measuring fatigue. In addition, the Multiple Sclerosis Quality of Life 54 questionnaire is used as a disease-specific instrument (MSQoL-54), which supplements the SF-36 questionnaire for recording health-related quality of life with 18 MS-specific items. Pain is measured using the visual analog scale (VAS), as it is a simple and frequently used method for measuring pain in clinical practice and is also considered a measure of treatment efficacy and can therefore provide a link to study results from other studies. The change in spasticity is measured using the Numerical Rating Scale (NRS). The self-assessment version of the ICF-based WHODAS 2.0 instrument will be used to measure activity- and participation-related parameters. In addition, an ICF-based EQUITEDO assessment to be completed by the therapists is used as an external assessment to document the progress and results of the hippotherapy measures in order to assess the activity- and participation-related parameters of the effectiveness of the therapy. Unforeseen or adverse events during the course of therapy are documented by the therapists using the Serious Adverse Event (SAE) Report Form and forwarded to the study team within 24 hours. | — |
Countries
Germany
Contacts
Public ContactIsabel Stolz
Deutsche Sporthochschule Köln
Outcome results
None listed