Effectiveness of Hippotherapy Simulator on Balance and Knee Strength in People With Multiple Sclerosis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Balance dysfunction in Multiple Sclerosis
研究概览
简要总结
A mechanical horse-riding simulator (MHRS) is a robotic device with a dynamic saddle that mimics the movement of a horse for purpose of hippotherapy. By simulating the rhythmic movements of the horse MHRS aims to increase the patient's balance, flexibility and adaptation and to provide postural adjustment. MHRS is supposed to produce walking patterns of a horse in a three-dimensional aspect. Movements in rhythmic repetitions improve postural coordination, allow to produce a reciprocal pattern. By simulating the rhythmic movements of a horse, MHRS aims to increase the patient's balance, flexibility and adaptation and to provide postural adjustment. This study aims to research the potential benefits of the mechanical horseback riding simulator on the postural balance and symptoms of multiple sclerosis 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 MS patients. 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.
This prospective clinical study aims to show potential benefits of horse riding in people with Multiple Sclerosis (PwMS) via a mechanical simulator.
Primer outcomes of the study are postural balance and muscle strength. Sample size calculation was performed and forty patients (inclusion and exclusion criteria will listed separately) were planned to be included in the study.
Participants will be allocated to the different treatment groups using the block randomization method.
All patients in both groups will planned 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
a blind physiotherapist will assess the study in outcomes in all patients.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent of the patient.
- •Minimum age of 18 years
- •Confirmed multiple sclerosis diagnosis.
- •Expanded Disability Status Scale (EDSS) score below seven
排除标准
- •Any vision or hearing problems,
- •The presence of other neurological, orthopedic or rheumatic problems that may limit shoulder-pelvic movement or cause pain,
- •Presence of physically disabled or uncontrolled chronic systemic disease,
- •Having had a major trauma,
- •To receive treatment for shoulder, hip, knee problems in the last 6 months,
- •Having had an MS attack in the last 3 months.
- •Pregnancy.
结局指标
主要结局
Balance dysfunction in Multiple Sclerosis
时间窗: At the end of the 12th week of exercise schedule
The Balance will be measured with the "The Timed Up \& Go (TUG)". TUG provides useful outcomes related to reduced falls risk. In patients with multiple sclerosis the Minimally Detectable Change was 3.5 seconds. Four teen seconds accepted as cut of scores (indicating risk of falls).
Muscle Strength
时间窗: At the end of the 12th week of exercise schedule
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.
次要结局
- Disability associated with Multiple Sclerosis(At the end of the 12th week of exercise schedule)
研究者
Ali Yavuz Karahan
Chairman of the Department of Rehabilitation Medicine
Uşak University