Effectiveness of Hippotherapy Simulator in PwMS

Effectiveness of Hippotherapy Simulator on Balance and Knee Strength in People With Multiple Sclerosis: a Randomized Controlled Trial

A mechanical horse-riding simulator (MHRS) is a robotic device with a dynamic saddle that mimics the movement of a horse for purpose of hippotherapy. By simulating the rhythmic movements of the horse MHRS aims to increase the patient's balance, flexibility and adaptation and to provide postural adjustment. MHRS is supposed to produce walking patterns of a horse in a three-dimensional aspect. Movements in rhythmic repetitions improve postural coordination, allow to produce a reciprocal pattern. By simulating the rhythmic movements of a horse, MHRS aims to increase the patient's balance, flexibility and adaptation and to provide postural adjustment. This study aims to research the potential benefits of the mechanical horseback riding simulator on the postural balance and symptoms of multiple sclerosis patients.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Exercise
• Intervention / Treatment: Other: Exercises

Detailed Description

Hippotherapy or therapeutic horseback riding therapy is a form of animal-assisted therapy that uses the horse as a modality that aims to improve postural control, balance and mobility. With hippotherapy, it is aimed to change the center of gravity by using the movements of the horse and to ensure the adaptation of the trunk and pelvis by developing righting and balance reactions against this new position. Current studies suggest that hippotherapy may be a useful complementary treatment approach for improving balance, fatigue, spasticity, walking and quality of life in MS patients. However, horseback riding therapy itself has some limitations as a treatment due to costs, location and risks. By its nature horse-riding is too dynamic for patients and requires a large outdoor space.

This prospective clinical study aims to show potential benefits of horse riding in people with Multiple Sclerosis (PwMS) via a mechanical simulator.

Primer outcomes of the study are postural balance and muscle strength. Sample size calculation was performed and forty patients (inclusion and exclusion criteria will listed separately) were planned to be included in the study.

Participants will be allocated to the different treatment groups using the block randomization method.

All patients in both groups will planned to complete exercise sessions 3 times a week for 12 weeks, each lasting 35 minutes per day.

For the Group 1 (horse-riding simulator group), patients will will perform a horse riding simulation exercise at speeds of 15km/h, 18km/h, 20km/h, 22km/h, 25km/h, each lasting 5 minutes after warm-up for 5 minutes in each session. Then they will rest for 5 minutes.For the safety, a physiotherapist will be accompanied to the exercises for this group.

For the Group 2 (home exercise group) patients will perform home exercises. Home exercises will be consist of a warm-up, stretching, balance, back walking, fingertip walking exercises, the first of which is shown by the physiatrist or physiotherapist to the patients. These patients will be called twice a month to ask whether they have done the exercises, and the patients whose participation rate is below 80% will be excluded from the study by following the exercise schedule when they come to the physician's control monthly.

All participants will be filled with My Multiple Sclerosis (MMMS) scale, Berg Balance Scale (BBS), Timed Up and Go Test, before treatment and at the end of the 12th week. Quadriceps muscle strength will be measured with the microFET®2 Dynamometer before treatment and at the end of the 12th week.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Uşak, Turkey, 64200
    • University of Usak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent of the patient.
• Minimum age of 18 years
• Confirmed multiple sclerosis diagnosis.
• Expanded Disability Status Scale (EDSS) score below seven

Exclusion Criteria:

• Any vision or hearing problems,
• The presence of other neurological, orthopedic or rheumatic problems that may limit shoulder-pelvic movement or cause pain,
• Presence of physically disabled or uncontrolled chronic systemic disease,
• Having had a major trauma,
• To receive treatment for shoulder, hip, knee problems in the last 6 months,
• Having had an MS attack in the last 3 months.
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exercise group 1: Exercise via mechanical horse-riding simulator; All patients in both groups were planned to complete exercise sessions 3 times a week for 12 weeks, each lasting 35 minutes per day.	Other: Exercises; Patients were planned to complete exercise sessions 3 times a week for 12 weeks, each lasting 35 minutes per day.
Active Comparator: Exercise group 2: Home exercises; Home exercises will be consist of a warm-up, stretching, balance, back walking, fingertip walking exercises, the first of which is shown by the physiatrist or physiotherapist to the patients. These patients will be called twice a month to ask whether they have done the exercises, and the patients whose participation rate is below 80% will be excluded from the study by following the exercise schedule when they come to the physician's control monthly.	Other: Exercises; Patients were planned to complete exercise sessions 3 times a week for 12 weeks, each lasting 35 minutes per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance dysfunction in Multiple Sclerosis	The Balance will be measured with the "The Timed Up & Go (TUG)". TUG provides useful outcomes related to reduced falls risk. In patients with multiple sclerosis the Minimally Detectable Change was 3.5 seconds. Four teen seconds accepted as cut of scores (indicating risk of falls).	At the end of the 12th week of exercise schedule
Muscle Strength	Quadriceps muscle strength will be measured with the microFET2 Dynamometer. The wireless microFET®2 Digital Handheld Dynamometer muscle tester is an accurate, portable Force Evaluation and Testing device. It is a modern adaptation of the time-tested art of hands-on manual muscle testing. Measurement Range 0-300 lbs force.	At the end of the 12th week of exercise schedule

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability associated with Multiple Sclerosis	Disability associated with Multiple Sclerosis will be detected with The Expanded Disability Status Scale. The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a physiatrist.	At the end of the 12th week of exercise schedule

Collaborators and Investigators

• Sponsor: Uşak University
• Investigators: Study Chair: Ali Y Karahan, MD, University of Usak

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): April 15, 2022
• Study Completion (Actual): April 15, 2022

Study Registration Dates

• First Submitted: November 15, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: exercise; multiple sclerosis; balance; strength; hippotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: Usak222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No