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Effectiveness of Hippotherapy Simulator in PwMS

Primary Purpose

Multiple Sclerosis, Exercise

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercises
Sponsored by
Uşak University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring hippotherapy, multiple sclerosis, balance, strength, exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Usak

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Exercise group 1: Exercise via mechanical horse-riding simulator

Exercise group 2: Home exercises

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 15, 2020
Last Updated
April 15, 2022
Sponsor
Uşak University
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1. Study Identification

Unique Protocol Identification Number
NCT04651725
Brief Title
Effectiveness of Hippotherapy Simulator in PwMS
Official Title
Effectiveness of Hippotherapy Simulator on Balance and Knee Strength in People With Multiple Sclerosis: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
April 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uşak University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Exercise
Keywords
hippotherapy, multiple sclerosis, balance, strength, exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized pretest-posttest control group design
Masking
Outcomes Assessor
Masking Description
a blind physiotherapist will assess the study in outcomes in all patients.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group 1: Exercise via mechanical horse-riding simulator
Arm Type
Active Comparator
Arm Description
All patients in both groups were planned to complete exercise sessions 3 times a week for 12 weeks, each lasting 35 minutes per day.
Arm Title
Exercise group 2: Home exercises
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercises
Intervention Description
Patients were planned to complete exercise sessions 3 times a week for 12 weeks, each lasting 35 minutes per day.
Primary Outcome Measure Information:
Title
Balance dysfunction in Multiple Sclerosis
Description
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).
Time Frame
At the end of the 12th week of exercise schedule
Title
Muscle Strength
Description
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.
Time Frame
At the end of the 12th week of exercise schedule
Secondary Outcome Measure Information:
Title
Disability associated with Multiple Sclerosis
Description
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.
Time Frame
At the end of the 12th week of exercise schedule

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Y Karahan, MD
Organizational Affiliation
University of Usak
Official's Role
Study Chair
Facility Information:
Facility Name
University of Usak
City
Uşak
ZIP/Postal Code
64200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Hippotherapy Simulator in PwMS

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