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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • University of Usak

    Uşak, 64200

Other trials in Turkey (Türkiye)

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.

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 groups in NCT04713813
Study groupRoleWhat they receive
Exercise group 1(Exercise via mechanical horse-riding simulator)Active comparatorExercise 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 comparatorHome 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.

  1. 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

  2. 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

  3. 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.

  1. First posted19 Jan 2021
  2. Study start13 Jan 2021
  3. Primary completion15 Apr 2022
  4. Study completion15 Apr 2022

Resources

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)
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

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.

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