Study on the evaluation of hippotherapy in the course of treatment for multiple sclerosis - a prospective, randomized controlled and multicenter study

Not Applicable

Completed

• Conditions: G35; Multiple sclerosis

• Registration Number: DRKS00005289
• Lead Sponsor: Zentrum für Therapeutisches Reiten Johannisberg e.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-09
• Study Completion: 2014-07-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Definite multiple sclerosis with spasticity of the lower limbs;

EDSS-Score between 4 and 6.5;

Presence of an informed consent form signed by the patient;

Consent of the responsible investigator;

Legal capacity;

Minimum age of 18 years

Exclusion Criteria

Hippotherapy within the last 12 months;

Parallel participation in other interventional studies;

Persons, who have an employment relationship/ a relationship of dependency on the sponsor or the investigator

Placing in an institution because of responsible governmental or judicial authorities;

Body weight above 90 kg;

Acute episode between 4 weeks prior to the start of the therapy;

No balance while sitting;

Planned start of an new spasmolytic drug or drugs, which could influence the tested parameters (for example Sativex®; Injection of Baclofen close to the spinal cord, 4-Aminopyridin);

cerebral seizure disorder, that is not medically adjusted;

No or insufficient ability to spread out the legs, which is necessary to sit on a horse;

Heavy osteoporosis;

Heavy arthrosis of the hip joint;

Heavy scoliosis, which could deteriorate under hippotherapy;

Heavy disorder of blood clotting, which increase the risk for bleedings because of hippotherapy

Unstable internal, gynaecological, surgical secondary illness;

Insurmountable fear of horses;

Allergy against horsehair;

Pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in balance ability:<br><br>Change of Berg-Balance-Scale (BBS) after 12 weeks of hippotherapy (relative to the initial value)

Secondary Outcome Measures

Name	Time	Method
Change in fatigue: Fatigue Severity Scale (FSS) after 12 weeks of hippotherapy (relative to the initial value);<br><br>Change in quality of life: Multiple Sclerosis Quality of Life-54 (MSQOL-54) after 12 weeks of hippotherapy (relative to the initial value);<br><br>Change in pain intensity: Visual Analogue Scale (VAS) after 12 weeks of hippotherapy (relative to the initial value);<br><br>Change in spasticity: Numeric Rating-Scale (NRS) after 12 weeks of hippotherapy (relative to the initial value)