Ankylosing SpondylitisNCT04713813
Effectiveness of Hippotherapy Simulator in Ankylosing Spondylitis
A study testing Therapeutic exercise program via hippotherapy mechanical stimulator and Therapeutic home exercise program in people with Ankylosing Spondylitis and Exercise, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
Recent studies and meta-analysis showed that different exercise plans had greater benefits than no invention group in improving pain, physical function, and disease activity, especially in some studies that involve ankylosing spondylitis patients receiving home-based exercise. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Ankylosing Spondylitis, Exercise
- What is being tested?
- Therapeutic exercise program via hippotherapy mechanical stimulator and Therapeutic home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jan 2021to 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ankylosing spondylitis diagnosis according to the modified New York criteria
- Voluntary participation in the study
- Age 18-45 years
- Regular use of disease-modifying anti-rheumatic drugs (methotrexate, sulfasalazine, and anti-tumor necrosis factor (TNF) agents) at a stable dosage for at least six weeks.
Who cannot join
- Exercising regularly during the previous six months.
- The presence of severe comorbidity that may affect the kidneys, liver, lungs, and heart such as cardiovascular, pulmonary, orthopedic, and neurological problems.
- Problems that may prevent exercise (uncontrollable hypertension, heart attack or history of coronary revascularization, history of syncope or exercise-related arrhythmia, decompensated Type 1 diabetes mellitus, history of hip and/or knee arthroplasty)
- Having undergone any surgery in the previous 6 months
- Any other neuromuscular disease that may affect the muscles' strength.
- Inability to participate in at least 80% of the exercises
Trial locations and contacts
1 site in 1 country.
About this study
Recent studies and meta-analysis showed that different exercise plans had greater benefits than no invention group in improving pain, physical function, and disease activity, especially in some studies that involve ankylosing spondylitis patients receiving home-based exercise. Different kinds of exercises are efficacious and should be recommended to AS patients. But, according to our current knowledge, no clear protocols regarding the effectiveness of hippotherapy in AS patients.
This study aims to investigate the effect of the therapeutic horseback riding therapy via a mechanical simulator on disease-specific outcomes and muscle strength of ankylosing spondylitis 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 different kinds of disabilities. 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. It is believed that a hippotherapy simulator is a therapeutic exercise option for the treatment of thoracolumbar segmental instability and hypo-mobility. Besides complications such as fractures caused by falling are greatly reduced using hippotherapy simulators under proper supervision. Hippotherapy with a mechanical stimulator simulates the motion of a horse as part of a continuous therapy package to provide postural or stability training. This exercise develops unified intuitive stimulation plus motor responses. It engages movement hits that are produced by the machine which mimicking the animal walks: this leads to beneficial consequences.
This prospective clinical study aims to investigate the effect of therapeutic horseback riding therapy via a mechanical simulator on disease-specific outcomes and muscle strength of ankylosing spondylitis patients.
This randomized, single-blind, controlled clinical trial will carry out at the University of Usak/ TURKEY.
This randomized, single-blind, controlled clinical trial will carry out at the University of Usak/ TURKEY. The study will include a total of 60 volunteers who had been diagnosed with AS according to the modified New York criteria. The subjects will be patients who are referred to the outpatient physical therapy center of the Physical Medicine and Rehabilitation Department of the Usak University.
Participants will be allocated to the different treatment groups using the block randomization method. All patients in both groups will continue their ongoing medications. But also, both groups will plan to complete exercise sessions 3 times a week for 12 weeks, each lasting 35 minutes per day.
For Group 1 (horse-riding simulator group), patients 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 five minutes. For safety, a physiotherapist will be accompanied to the exercises for this group.
For 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.
During the study, if, any subject making any changes to the drug treatment will withdraw from the study.
Evaluations will make before and after treatment. All evaluations will perform by the same experienced physiotherapists who will be blind to the study groups.
Primer outcomes of the study; The Bath AS Disease Activity Index (BASDAI) and Bath AS Disease Functional Index (BASFI) will be used for the activity-related disease, function, and baseline measurements of the participants, respectively.
Quadriceps muscle strength will be measured with the microFET®2 Dynamometer. Bath AS Disease Activity Index (BASDAI): This index, which was developed to evaluate disease activity, consists of 6 VAS measurements. These are fatigue, spine, and peripheral joint pain, sensitivity, and morning stiffness measurements.
Bath AS Disease Functional Index (BASFI): BASFI measures the functional capacity of the patient in the previous week. This index consists of 8 questions about daily activities and 2 questions evaluating the patient's ability to cope with daily life. The degree of difficulty felt by the patient in performing specified tasks is marked on a 10 cm visual analog scale. The average of the total score obtained from 10 questions is calculated for use in the analysis.
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.
- Conditions
- Ankylosing Spondylitis, Exercise
- Being tested
- Therapeutic exercise program via hippotherapy mechanical stimulator, Therapeutic home exercise program
- Keywords
- Hippotherapy, occupational therapy, horse, Exercise therapy
- Medical subject headings
- Spondylitis, Ankylosing, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exercise program via hippotherapy mechanical stimulatorOther
Patients were planned to complete hippotherapy exercises sessions 3 times a week for 12 weeks, each lasting 35 minutes per sessions.
Therapeutic home exercise programOther
Patients were planned to complete home exercises sessions 3 times a week for 12 weeks, each lasting 35 minutes per sessions.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group 1(Exercise via mechanical horse-riding simulator) | Active comparator | Exercise via mechanical horse-riding simulator; Subjects remained in sitting position for 30 minutes on the simulator during these sessions, with extension of the trunk and stabilization of the pelvis. Feet were placed on the footplates as the simulator produced a rhythmic and repetitive movement similar to a walking horse. The simulator can produce several modes of rhythmic and repetitive motions. Receives: Other: Therapeutic exercise program via hippotherapy mechanical stimulator |
| 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: Therapeutic home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps muscle strength
Quadriceps muscle strength will be measured with the microFET®2 Dynamometer.
Measured: At the end of the 12th week of exercise schedule
Bath Ankylosing Spondylitis Disease Activity Index
The Bath Ankylosing Spondylitis Disease Activity Index consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions asked of the patient pertaining to the five major symptoms of AS: Spinal pain, Fatigue, Arthralgia, Enthesitis, Morning stiffness severity, Morning stiffness duration.
The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 score. Scores of 4 or greater suggest suboptimal control of disease. Higher values indicate more active disease.
Measured: At the end of the 12th week of exercise schedule
Bath Ankylosing Spondylitis Disease Functional Index
The ten questions that comprise The Bath Ankylosing Spondylitis Functional Index were chosen with input from patients with Ankylosing spondylitis. The first 8 questions evaluate activities related to functional anatomical limitations due to the course of this inflammatory disease. The final 2 questions evaluate the patients' ability to cope with everyday life.
A visual analogue scale (with 0 being "easy" and 10 "impossible) is used to answer the questions on the test.
The mean of the ten scales gives the Bath Ankylosing Spondylitis Functional Index score - a value between 0 and 10.
A higher score indicates a higher degree of functional limitations.
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 posted19 Jan 2021
- Study start13 Jan 2021
- 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 Ankylosing SpondylitisStudies 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, single-blind, controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Y KARAHAN, MD, Principal investigator, Department of Physical Medicine and Rehabilitation Medical Faculty of Usak University /Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713813
- Sponsor's protocol ID
- ayk222
- Status last verified
- Apr 2022
- First submitted
- 12 Jan 2021
- 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 in Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT04713813
- Acronym / sponsor ID
- ayk222
- Conditions
- Ankylosing Spondylitis, Exercise
- Keywords
- Hippotherapy, occupational therapy, horse, Exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 19 Jan 2021 (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.
Recent studies and meta-analysis showed that different exercise plans had greater benefits than no invention group in improving pain, physical function, and disease activity, especially in some studies that involve ankylosing spondylitis patients receiving home-based exercise. Different kinds of exercises are efficacious and should be recommended to AS patients. But, according to our current knowledge, no clear protocols regarding the effectiveness of hippotherapy in AS patients.
This study aims to investigate the effect of the therapeutic horseback riding therapy via a mechanical simulator on disease-specific outcomes and muscle strength of ankylosing spondylitis 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 different kinds of disabilities. 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. It is believed that a hippotherapy simulator is a therapeutic exercise option for the treatment of thoracolumbar segmental instability and hypo-mobility. Besides complications such as fractures caused by falling are greatly reduced using hippotherapy simulators under proper supervision. Hippotherapy with a mechanical stimulator simulates the motion of a horse as part of a continuous therapy package to provide postural or stability training. This exercise develops unified intuitive stimulation plus motor responses. It engages movement hits that are produced by the machine which mimicking the animal walks: this leads to beneficial consequences.
This prospective clinical study aims to investigate the effect of therapeutic horseback riding therapy via a mechanical simulator on disease-specific outcomes and muscle strength of ankylosing spondylitis patients.
This randomized, single-blind, controlled clinical trial will carry out at the University of Usak/ TURKEY.
This randomized, single-blind, controlled clinical trial will carry out at the University of Usak/ TURKEY. The study will include a total of 60 volunteers who had been diagnosed with AS according to the modified New York criteria. The subjects will be patients who are referred to the outpatient physical therapy center of the Physical Medicine and Rehabilitation Department of the Usak University.
Participants will be allocated to the different treatment groups using the block randomization method. All patients in both groups will continue their ongoing medications. But also, both groups will plan to complete exercise sessions 3 times a week for 12 weeks, each lasting 35 minutes per day.
For Group 1 (horse-riding simulator group), patients 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 five minutes. For safety, a physiotherapist will be accompanied to the exercises for this group.
For 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.
During the study, if, any subject making any changes to the drug treatment will withdraw from the study.
Evaluations will make before and after treatment. All evaluations will perform by the same experienced physiotherapists who will be blind to the study groups.
Primer outcomes of the study; The Bath AS Disease Activity Index (BASDAI) and Bath AS Disease Functional Index (BASFI) will be used for the activity-related disease, function, and baseline measurements of the participants, respectively.
Quadriceps muscle strength will be measured with the microFET®2 Dynamometer. Bath AS Disease Activity Index (BASDAI): This index, which was developed to evaluate disease activity, consists of 6 VAS measurements. These are fatigue, spine, and peripheral joint pain, sensitivity, and morning stiffness measurements.
Bath AS Disease Functional Index (BASFI): BASFI measures the functional capacity of the patient in the previous week. This index consists of 8 questions about daily activities and 2 questions evaluating the patient's ability to cope with daily life. The degree of difficulty felt by the patient in performing specified tasks is marked on a 10 cm visual analog scale. The average of the total score obtained from 10 questions is calculated for use in the analysis.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, single-blind, controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Exercise group 1(Exercise via mechanical horse-riding simulator) | Active comparator | Other: Therapeutic exercise program via hippotherapy mechanical stimulatorExercise via mechanical horse-riding simulator; Subjects remained in sitting position for 30 minutes on the simulator during these sessions, with extension of the trunk and stabilization of the pelvis. Feet were placed on the footplates as the simulator produced a rhythmic and repetitive movement similar to a walking horse. The simulator can produce several modes of rhythmic and repetitive motions. |
| Exercise group 2 (Home exercises) | Active comparator | Other: Therapeutic home exercise programHome 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 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ankylosing spondylitis diagnosis according to the modified New York criteria
- Voluntary participation in the study
- Age 18-45 years
- Regular use of disease-modifying anti-rheumatic drugs (methotrexate, sulfasalazine, and anti-tumor necrosis factor (TNF) agents) at a stable dosage for at least six weeks.
Key exclusion criteria (6 listed)
- Exercising regularly during the previous six months.
- The presence of severe comorbidity that may affect the kidneys, liver, lungs, and heart such as cardiovascular, pulmonary, orthopedic, and neurological problems.
- Problems that may prevent exercise (uncontrollable hypertension, heart attack or history of coronary revascularization, history of syncope or exercise-related arrhythmia, decompensated Type 1 diabetes mellitus, history of hip and/or knee arthroplasty)
- Having undergone any surgery in the previous 6 months
- Any other neuromuscular disease that may affect the muscles' strength.
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 |
|---|---|---|
| Therapeutic exercise program via hippotherapy mechanical stimulatorPatients were planned to complete hippotherapy exercises sessions 3 times a week for 12 weeks, each lasting 35 minutes per sessions. | Other | Exercise group 1(Exercise via mechanical horse-riding simulator) |
| Therapeutic home exercise programPatients were planned to complete home exercises sessions 3 times a week for 12 weeks, each lasting 35 minutes per sessions. | Other | Exercise group 2 (Home exercises) |
Primary outcome
Quadriceps muscle strength
Time frame: At the end of the 12th week of exercise schedule
Quadriceps muscle strength will be measured with the microFET®2 Dynamometer.
Bath Ankylosing Spondylitis Disease Activity Index
Time frame: At the end of the 12th week of exercise schedule
The Bath Ankylosing Spondylitis Disease Activity Index consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions asked of the patient pertaining to the five major symptoms of AS: Spinal pain, Fatigue, Arthralgia, Enthesitis, Morning stiffness severity, Morning stiffness duration. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 score. Scores of 4 or greater suggest suboptimal control of disease. Higher values indicate more active disease.
Bath Ankylosing Spondylitis Disease Functional Index
Time frame: At the end of the 12th week of exercise schedule
The ten questions that comprise The Bath Ankylosing Spondylitis Functional Index were chosen with input from patients with Ankylosing spondylitis. The first 8 questions evaluate activities related to functional anatomical limitations due to the course of this inflammatory disease. The final 2 questions evaluate the patients' ability to cope with everyday life. A visual analogue scale (with 0 being "easy" and 10 "impossible) is used to answer the questions on the test. The mean of the ten scales gives the Bath Ankylosing Spondylitis Functional Index score - a value between 0 and 10. A higher score indicates a higher degree of functional limitations.
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 principal investigator
Department of Physical Medicine and Rehabilitation Medical Faculty of Usak University /Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercise program via hippotherapy mechanical stimulator and Therapeutic home exercise program in people with Ankylosing Spondylitis 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 6 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?
Quadriceps muscle strength (time frame: At the end of the 12th week of exercise schedule). The study lists 3 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.