Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04713813
Status:
COMPLETED
Last Update Posted:
2022-04-18
First Post:
2021-01-12
Brief Title:
Effectiveness of Hippotherapy Simulator in Ankylosing Spondylitis
Sponsor:
Uşak University
Organization:
Uşak University
Study Overview
Official Title:
Effectiveness of Hippotherapy Simulator in Ankylosing Spondylitis
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 15kmh 18kmh 20kmh 22kmh 25kmh 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 physicians 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 microFET2 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 patients 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 microFET2 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
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 15kmh 18kmh 20kmh 22kmh 25kmh 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 physicians 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 microFET2 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 patients 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 microFET2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None