Effectiveness of Hippotherapy Simulator in PwMS

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04651725
• Other study ID #: Usak222
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: April 15, 2022

Study information

• Verified date: April 2022
• Source: Usak University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exercise
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Exercises
Patients were planned to complete exercise sessions 3 times a week for 12 weeks, each lasting 35 minutes per day.

Locations

Country	Name	City	State
Turkey	University of Usak	Usak

Sponsors (1)

Lead Sponsor	Collaborator
Usak University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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