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Completed

NCT Number: NCT04651725

Effectiveness of Hippotherapy Simulator in PwMS

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Usak

Uşak, 64200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercises

Other

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

Primary outcomes

  1. Balance dysfunction in Multiple Sclerosis

    Time frame: At the end of the 12th week of exercise schedule

    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).

  2. Muscle Strength

    Time frame: At the end of the 12th week of exercise schedule

    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.

Secondary outcomes

  1. Disability associated with Multiple Sclerosis

    Time frame: At the end of the 12th week of exercise schedule

    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.

Sponsors and collaborators

Lead sponsor

Uşak University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 3, 2020
Registry last updated
Apr 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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