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临床试验/NCT04713813
NCT04713813已完成不适用

Effectiveness of Hippotherapy Simulator in Ankylosing Spondylitis

Uşak University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Quadriceps muscle strength

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

All evaluations for outcomes will perform by the same experienced physiotherapists who will be blind to the study groups.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Quadriceps muscle strength

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Uşak University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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