Multiple SclerosisNCT04651725
Effectiveness of Hippotherapy Simulator in PwMS
A study testing Exercises in people with Multiple Sclerosis and Exercise, run by Uşak University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Exercise
- What is being tested?
- Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2020to 15 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent of the patient.
- Minimum age of 18 years
- Confirmed multiple sclerosis diagnosis.
- Expanded Disability Status Scale (EDSS) score below seven
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis, Exercise
- Being tested
- Exercises
- Keywords
- hippotherapy, multiple sclerosis, balance, strength, exercise
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesOther
Patients were planned to complete exercise sessions 3 times a week for 12 weeks, each lasting 35 minutes per day.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group 1: Exercise via mechanical horse-riding simulator | Active comparator | All patients in both groups were planned to complete exercise sessions 3 times a week for 12 weeks, each lasting 35 minutes per day. Receives: Other: Exercises |
| Exercise group 2: Home exercises | Active comparator | 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. Receives: Other: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: At the end of the 12th week of exercise schedule
Secondary outcomes (1)
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.
Measured: At the end of the 12th week of exercise schedule
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Nov 2020
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized pretest-posttest control group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Yavuz Karahan, Uşak University
- Investigators
- Ali Y Karahan, MD, Study chair, University of Usak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651725
- Sponsor's protocol ID
- Usak222
- Status last verified
- Apr 2022
- First submitted
- 15 Nov 2020
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Hippotherapy Simulator on Balance and Knee Strength in People With Multiple Sclerosis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04651725
- Acronym / sponsor ID
- Usak222
- Conditions
- Multiple Sclerosis, Exercise
- Keywords
- hippotherapy, multiple sclerosis, balance, strength, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized pretest-posttest control group design
| Arm | Type | Receives |
|---|---|---|
| Exercise group 1: Exercise via mechanical horse-riding simulator | Active comparator | Other: ExercisesAll patients in both groups were planned to complete exercise sessions 3 times a week for 12 weeks, each lasting 35 minutes per day. |
| Exercise group 2: Home exercises | Active comparator | Other: ExercisesHome 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent of the patient.
- Minimum age of 18 years
- Confirmed multiple sclerosis diagnosis.
- Expanded Disability Status Scale (EDSS) score below seven
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExercisesPatients were planned to complete exercise sessions 3 times a week for 12 weeks, each lasting 35 minutes per day. | Other | Exercise group 1: Exercise via mechanical horse-riding simulator, Exercise group 2: Home exercises |
Primary outcome
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).
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.
1 secondary outcome
Disability associated with Multiple Sclerosis
Time frame: At the end of the 12th week of exercise schedule
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Y Karahan, MD study chair
University of Usak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises in people with Multiple Sclerosis and Exercise, run by Uşak University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance dysfunction in Multiple Sclerosis (time frame: At the end of the 12th week of exercise schedule). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.