Multiple SclerosisNCT06005909
Current Exercise Approaches in Patients With Multiple Sclerosis
A study testing Cawthorne-Cooksey Exercises and Mechanical Hippotherapy Exercises in people with Multiple Sclerosis, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to examine the effects of exercises performed with mechanical hippotherapy device and Cawthorne-Cooksey exercises on balance, dizziness, fatigue and quality of life in patients with Multiple Sclerosis. Read more about this study
- Who is it for?
- Ages 25 to 64 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Cawthorne-Cooksey Exercises and Mechanical Hippotherapy Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 30 Apr 2023
- 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 25 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being cooperative and oriented,
- Being 25 - 64 years
- Having a definite diagnosis of MS,
- Being able to sit dependent/independently and stand supported/unsupported,
- Not having an attack in the last 1 month or not currently in the attack period,
- Volunteering to participate in the study.
Who cannot join
- Having another neurological disease or musculoskeletal system problems in addition to the diagnosis of MS,
- Being on cortisone treatment in the last 1 month or still ongoing,
- Having a mental, cardiovascular, pulmonary or orthopedic disease that will prevent exercise.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Istanbul Hospital
Üsküdar, Istanbul
About this study
Official title: Investigation of the Effects of Exercises With Mechanical Hippotherapy Device and Cawthorne-Cooksey Exercises on Balance, Dizziness, Fatigue and Quality of Life in Patients With Multiple Sclerosis.
This study was conducted to examine the effects of exercises performed with mechanical hippotherapy device and Cawthorne-Cooksey exercises on balance, dizziness, fatigue and quality of life in patients with Multiple Sclerosis.
Read the detailed description
The research is a quantitative study, and it is in the form of randomized controlled type research, one of the experimental research types. In order to provide a homogeneous distribution, the patients were divided into two different exercise groups using the double-blind method from the minimization method.
The sample of the study consisted of definitively diagnosed multiple sclerosis (MS) patients who volunteered to participate in the study. Patients who voluntarily agreed to participate in the study; While they were informed about the aims of the study, the duration of the study, the evaluation methods and the applications to be made, the informed consent form was signed by these patients and their consent was obtained. The study sample was divided into two groups by randomization method. The first group was given 35 minutes of traditional physical therapy program and 15 minutes of exercises with a mechanical hippotherapy device, while the second group was given 15 minutes of Cawthorne-Cooksey exercises in addition to the 35-minute traditional physical therapy program. Both exercise groups were given a 50-minute physical therapy program. Patients diagnosed with Multiple Sclerosis in the study; It was classified according to the Expanded Disability Status Scale Score. Tinetti Balance Rating Scale was used to assess balance. The Dizziness Disability Inventory was used to assess dizziness, the Fatigue Severity Scale and the Fatigue Impact Scale to assess fatigue, and the Ferrans \& Powers Quality of Life Index MS Adaptation to assess quality of life.
- Conditions
- Multiple Sclerosis
- Being tested
- Cawthorne-Cooksey Exercises, Mechanical Hippotherapy Exercises
- Keywords
- Dizziness, Cawthorne-Cooksey, Hippotherapy simulator, Balance, Multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cawthorne-Cooksey ExercisesOther
A- Head and Eye Movements While Lying and Sitting:
- While keeping your head still, look up and then down again.
- Look from side to side while keeping your head still.
- Extend your hand at arm's length, draw your fingers towards your nose while focusing your eyes on your fingers.
- With eyes open, slowly turn your head from side to side.
- Turn your head from side to side quickly.
- With eyes open, slowly move your head up and down.
- Move your head up and down quickly.
- Repeat items 4,5,6 and 7 with your eyes closed.
B-Head and Body Movements While Sitting:
- Place an object on the floor in front of your feet, reach out to pick it up, then upright return to your position. Looking down while picking up the item, then Remind you to look up when trying to fix it.
- Lean forward and move the object forward and back under your knees. C- Standing Exercises
1-Get from a sitting position to a standing position and sit down again. 2-Repeat this with your eyes closed.
Mechanical Hippotherapy ExercisesOther
From the patient on the mechanical hippotherapy device;
- Maintaining trunk balance while raising both hands above head,
- Maintaining trunk balance while opening the arms next to the trunk,
- Maintaining trunk balance while extending the arms back and forth with successive movements,
- Maintaining trunk balance with hands clasped behind the waist,
- The arms are open to both sides, while transferring the weight ball from one hand to the other, it is requested to maintain the body balance.
| Study group | Role | What they receive |
|---|---|---|
| Cawthorne-Cooksey | Experimental | These exercises, which are designed to reduce vertigo, stabilize the gaze and improve balance by stimulating or operating the vestibular system during daily activities, consist of a series of eye, head, trunk and balance movements that provoke vestibular symptoms and whose difficulty increases. The degree of difficulty of the exercises was increased with the improvement of the patient. Head and trunk movements while sitting, standing and walking were added to the exercises that initially started with simple eye-head movements in bed. Receives: Other: Cawthorne-Cooksey Exercises |
| Mechanical Hippotherapy | Experimental | Before being taken to the device, the patients were informed about the working principle of the device, the exercises to be performed on the device, and that the exercise would be terminated in case of a possible health problem. After being placed on the device, the patient was given time until the initial balance was achieved. When the patient felt ready, a 15-minute hippotherapy session was applied at the 5th level of the 20-stage speed level by the physiotherapist. Receives: Other: Mechanical Hippotherapy Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue severity scale
The lowest score that can be obtained from the scale is 9, and the highest score is 63. The fatigue severity scale is the average value of nine sections. A high score indicates increased fatigue severity. The scale, including the day it was filled, questions the state of fatigue in the last 1 month.
Measured: 10 weeks
Fatigue Impact Scale
The scale consists of 40 questions. The first 10 items evaluate the cognitive state, the second 10 items evaluate the physical state, and the third 20 items evaluate the psychological state. Participants gave each question a score between 0 (no problem) and 4 (maximum problem). The highest score is 160. High scores indicate fatigue. The scales question the state of fatigue in the last 1 month, including the day it was filled in. The fatigue impact scale was found to be the most ideal scale to evaluate the effect of fatigue on daily life in MS.
Measured: 10 weeks
Tinetti balance rating scale
The scale includes gait (AS) and balance (EP) subgroups. Evaluation is made with specific scoring criteria for each activity. The total score is a maximum of 28, including the walking subgroup score and the balance subgroup score. The scores obtained by the participants were recorded separately for walking and balance, and the total score was also written. Scores of 18 and below are associated with high, scores between 19 and 23 are associated with moderate, and scores of 24 and above are associated with a low risk of falling.
Measured: 10 weeks
Dizziness disability inventory
The participants were asked to score this inventory, which consists of 25 items, according to the frequency and severity of the vertigo complaint and the degree of impact it creates in daily life. Sub-inventories are intended to determine the physical, sensory and functional effects of vestibular system diseases. In the scoring of the sub-units of the inventory, 28 points determine physical disability, 36 points functional and sensory disability. The scores obtained were recorded as physical disability, emotional disability and functional disability data. The final result consists of the sum of all of them. High scores are interpreted as the patient's vertigo complaint preventing his further life.
Measured: 10 weeks
Ferrans&Powers quality of life index
This index has 5 subcategories. These; total quality of life score, health and functionality subcategory score, social and economic subcategory score, psychological/belief subcategory score and family subcategory score. The test has two parts, satisfaction and importance, and each part has the same number of questions, question content is the same. The participants were asked to fill in the questionnaire and the physiotherapist calculated the values in accordance with the scoring instructions. The score of these collected values was divided by the number of marked questions. The final score was obtained by adding 15 to the obtained values. The final score is between 0-30.
Measured: 10 weeks
Extended disability status scale
In the Disability Status Scale, the patient is evaluated over a total of 10 points. While zero indicates normal health status, 10 indicates death due to an uncommon Multiple Sclerosis. In this scale, which consists of twenty steps, 0 indicates normal neurological finding; 10 means death due to MS. Scores on the Extended disability status scale increase to correspond with worsening in MS. The first score after 0 is 1, and then clinical worsening is expressed in 0.5-point intervals.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Feb 2022
- Primary completion1 May 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
- Investigators
- Alesta KABUK, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005909
- Sponsor's protocol ID
- Uskudar62
- Status last verified
- Aug 2023
- First submitted
- 16 Aug 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coban O, Mutluay F. The effects of mechanical hippotherapy riding on postural control, balance, and quality of life (QoL) in patients with stroke. Disabil Rehabil. 2024 Jun;46(11):2338-2347. doi: 10.1080/09638288.2023.2221458. Epub 2023 Jun 11.
PubMed 37303153Tacalan E, Inal HS, Senturk MN, Mengi E, Alemdaroglu-Gurbuz I. Effectiveness of the Epley maneuver versus Cawthorne-Cooksey vestibular exercises in the treatment of posterior semicircular canal benign paroxysmal positional vertigo (BPPV): A randomized controlled trial. J Bodyw Mov Ther. 2021 Oct;28:397-405. doi: 10.1016/j.jbmt.2021.07.030. Epub 2021 Aug 8.
PubMed 34776169Afrasiabifar A, Karami F, Najafi Doulatabad S. Comparing the effect of Cawthorne-Cooksey and Frenkel exercises on balance in patients with multiple sclerosis: a randomized controlled trial. Clin Rehabil. 2018 Jan;32(1):57-65. doi: 10.1177/0269215517714592. Epub 2017 Jun 19.
PubMed 28629268
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Exercises With Mechanical Hippotherapy Device and Cawthorne-Cooksey Exercises on Balance, Dizziness, Fatigue and Quality of Life in Patients With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT06005909
- Acronym / sponsor ID
- Uskudar62
- Conditions
- Multiple Sclerosis
- Keywords
- Dizziness, Cawthorne-Cooksey, Hippotherapy simulator, Balance, Multiple sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 23 Aug 2023 (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.
This study was conducted to examine the effects of exercises performed with mechanical hippotherapy device and Cawthorne-Cooksey exercises on balance, dizziness, fatigue and quality of life in patients with Multiple Sclerosis.
Detailed description
The research is a quantitative study, and it is in the form of randomized controlled type research, one of the experimental research types. In order to provide a homogeneous distribution, the patients were divided into two different exercise groups using the double-blind method from the minimization method.
The sample of the study consisted of definitively diagnosed multiple sclerosis (MS) patients who volunteered to participate in the study. Patients who voluntarily agreed to participate in the study; While they were informed about the aims of the study, the duration of the study, the evaluation methods and the applications to be made, the informed consent form was signed by these patients and their consent was obtained. The study sample was divided into two groups by randomization method. The first group was given 35 minutes of traditional physical therapy program and 15 minutes of exercises with a mechanical hippotherapy device, while the second group was given 15 minutes of Cawthorne-Cooksey exercises in addition to the 35-minute traditional physical therapy program. Both exercise groups were given a 50-minute physical therapy program. Patients diagnosed with Multiple Sclerosis in the study; It was classified according to the Expanded Disability Status Scale Score. Tinetti Balance Rating Scale was used to assess balance. The Dizziness Disability Inventory was used to assess dizziness, the Fatigue Severity Scale and the Fatigue Impact Scale to assess fatigue, and the Ferrans \& Powers Quality of Life Index MS Adaptation to assess quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cawthorne-Cooksey | Experimental | Other: Cawthorne-Cooksey ExercisesThese exercises, which are designed to reduce vertigo, stabilize the gaze and improve balance by stimulating or operating the vestibular system during daily activities, consist of a series of eye, head, trunk and balance movements that provoke vestibular symptoms and whose difficulty increases. The degree of difficulty of the exercises was increased with the improvement of the patient. Head and trunk movements while sitting, standing and walking were added to the exercises that initially started with simple eye-head movements in bed. |
| Mechanical Hippotherapy | Experimental | Other: Mechanical Hippotherapy ExercisesBefore being taken to the device, the patients were informed about the working principle of the device, the exercises to be performed on the device, and that the exercise would be terminated in case of a possible health problem. After being placed on the device, the patient was given time until the initial balance was achieved. When the patient felt ready, a 15-minute hippotherapy session was applied at the 5th level of the 20-stage speed level by the physiotherapist. |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being cooperative and oriented,
- Being 25 - 64 years
- Having a definite diagnosis of MS,
- Being able to sit dependent/independently and stand supported/unsupported,
- Not having an attack in the last 1 month or not currently in the attack period,
Key exclusion criteria (3 listed)
- Having another neurological disease or musculoskeletal system problems in addition to the diagnosis of MS,
- Being on cortisone treatment in the last 1 month or still ongoing,
- Having a mental, cardiovascular, pulmonary or orthopedic disease that will prevent exercise.
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 |
|---|---|---|
| Cawthorne-Cooksey ExercisesA- Head and Eye Movements While Lying and Sitting: 1. While keeping your head still, look up and then down again. 2. Look from side to side while keeping your head still. 3. Extend your hand at arm's length, draw your fingers towards your nose while focusing your eyes on your fingers. 4. With eyes open, slowly turn your head from side to side. 5. Turn your head from side to side quickly. 6. With eyes open, slowly move your head up and down. 7. Move your head up and down quickly. 8. Repeat items 4,5,6 and 7 with your eyes closed. B-Head and Body Movements While Sitting: 1. Place an object on the floor in front of your feet, reach out to pick it up, then upright return to your position. Looking down while picking up the item, then Remind you to look up when trying to fix it. 2. Lean forward and move the object forward and back under your knees. C- Standing Exercises 1-Get from a sitting position to a standing position and sit down again. 2-Repeat this with your eyes closed. | Other | Cawthorne-Cooksey |
| Mechanical Hippotherapy ExercisesFrom the patient on the mechanical hippotherapy device; * Maintaining trunk balance while raising both hands above head, * Maintaining trunk balance while opening the arms next to the trunk, * Maintaining trunk balance while extending the arms back and forth with successive movements, * Maintaining trunk balance with hands clasped behind the waist, * The arms are open to both sides, while transferring the weight ball from one hand to the other, it is requested to maintain the body balance. | Other | Mechanical Hippotherapy |
Primary outcome
Fatigue severity scale
Time frame: 10 weeks
The lowest score that can be obtained from the scale is 9, and the highest score is 63. The fatigue severity scale is the average value of nine sections. A high score indicates increased fatigue severity. The scale, including the day it was filled, questions the state of fatigue in the last 1 month.
Fatigue Impact Scale
Time frame: 10 weeks
The scale consists of 40 questions. The first 10 items evaluate the cognitive state, the second 10 items evaluate the physical state, and the third 20 items evaluate the psychological state. Participants gave each question a score between 0 (no problem) and 4 (maximum problem). The highest score is 160. High scores indicate fatigue. The scales question the state of fatigue in the last 1 month, including the day it was filled in. The fatigue impact scale was found to be the most ideal scale to evaluate the effect of fatigue on daily life in MS.
Tinetti balance rating scale
Time frame: 10 weeks
The scale includes gait (AS) and balance (EP) subgroups. Evaluation is made with specific scoring criteria for each activity. The total score is a maximum of 28, including the walking subgroup score and the balance subgroup score. The scores obtained by the participants were recorded separately for walking and balance, and the total score was also written. Scores of 18 and below are associated with high, scores between 19 and 23 are associated with moderate, and scores of 24 and above are associated with a low risk of falling.
Dizziness disability inventory
Time frame: 10 weeks
The participants were asked to score this inventory, which consists of 25 items, according to the frequency and severity of the vertigo complaint and the degree of impact it creates in daily life. Sub-inventories are intended to determine the physical, sensory and functional effects of vestibular system diseases. In the scoring of the sub-units of the inventory, 28 points determine physical disability, 36 points functional and sensory disability. The scores obtained were recorded as physical disability, emotional disability and functional disability data. The final result consists of the sum of all of them. High scores are interpreted as the patient's vertigo complaint preventing his further life.
Ferrans&Powers quality of life index
Time frame: 10 weeks
This index has 5 subcategories. These; total quality of life score, health and functionality subcategory score, social and economic subcategory score, psychological/belief subcategory score and family subcategory score. The test has two parts, satisfaction and importance, and each part has the same number of questions, question content is the same. The participants were asked to fill in the questionnaire and the physiotherapist calculated the values in accordance with the scoring instructions. The score of these collected values was divided by the number of marked questions. The final score was obtained by adding 15 to the obtained values. The final score is between 0-30.
Extended disability status scale
Time frame: 10 weeks
In the Disability Status Scale, the patient is evaluated over a total of 10 points. While zero indicates normal health status, 10 indicates death due to an uncommon Multiple Sclerosis. In this scale, which consists of twenty steps, 0 indicates normal neurological finding; 10 means death due to MS. Scores on the Extended disability status scale increase to correspond with worsening in MS. The first score after 0 is 1, and then clinical worsening is expressed in 0.5-point intervals.
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 23 Aug 2023.
- Background: PubMed 37303153Coban O, Mutluay F. The effects of mechanical hippotherapy riding on postural control, balance, and quality of life (QoL) in patients with stroke. Disabil Rehabil. 2024 Jun;46(11):2338-2347. doi: 10.1080/09638288.2023.2221458. Epub 2023 Jun 11.
- Background: PubMed 34776169Tacalan E, Inal HS, Senturk MN, Mengi E, Alemdaroglu-Gurbuz I. Effectiveness of the Epley maneuver versus Cawthorne-Cooksey vestibular exercises in the treatment of posterior semicircular canal benign paroxysmal positional vertigo (BPPV): A randomized controlled trial. J Bodyw Mov Ther. 2021 Oct;28:397-405. doi: 10.1016/j.jbmt.2021.07.030. Epub 2021 Aug 8.
- Background: PubMed 28629268Afrasiabifar A, Karami F, Najafi Doulatabad S. Comparing the effect of Cawthorne-Cooksey and Frenkel exercises on balance in patients with multiple sclerosis: a randomized controlled trial. Clin Rehabil. 2018 Jan;32(1):57-65. doi: 10.1177/0269215517714592. Epub 2017 Jun 19.
- 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.
Alesta KABUK study chair
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cawthorne-Cooksey Exercises and Mechanical Hippotherapy Exercises in people with Multiple Sclerosis, run by Uskudar 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 6 inclusion and 3 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 23 Aug 2023. 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?
Fatigue severity scale (time frame: 10 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06005909, which also lists 3 linked publications.
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 23 Aug 2023.