Comparison of the International Cooperative Ataxia Rating Scale (ICARS) and Scale for the Assessment and Rating of Ataxia (SARA) Scores With Face-to-Face and Tele-Assessment Methods in Ataxic Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- SARA
研究概览
简要总结
Our aim is to compare ICARS and SARA scores with face-to-face and tele-assessment methods in ataxic multiple sclerosis patients.
The hypotheses on which this study is based are; H1: Tele-assessment and face-to-face assessment results of the ICARS differ in patients with ataxic MS.
H2: Tele-assessment and face-to-face assessment results of SARA differ in patients with Ataxic MS.
详细描述
Patients will be evaluated both face-to-face and via tele-assessment (video conference call). In these evaluations, ICARS and SARA will be used. Face-to-face and tele-assessments will be applied on the same day, the order of administration will be decided by the randomization method, and a 10-minute rest will be given between the assessments.The interview will be recorded during the tele-assessment and a re-assessment will be made on the same recording 1 week later. Face-to-face assessment will be done as routinely done in the clinic. Face-to-face and tele-assessments will be made by 3 different assessors. Assessors will be blind to each other's assessment. All assessments will be carried out at Hacettepe University Faculty of Physical Therapy and Rehabilitation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be between the ages of 18-50 years
- •Being diagnosed with MS by a neurologist
- •Expanded Disability Status Scale (EDSS) score between 3-5
- •EDSS pyramidal system score ≤ 3 and cerebellar functional system score ≥ 1
- •Being clinically stable for the last 3 months
- •agree to participate in the study
排除标准
- •Having other systemic, orthopedic or neurological disease
- •Having a history of attacks in the last 3 months
- •having peripheral vestibular complaints
- •being mentally affected (Montreal Cognitive Rating Scale Score < 21)
- •severe spasticity (Modified Ashworth Scale > 3)
结局指标
主要结局
SARA
时间窗: up to 6 months
It will be used to assess the severity of ataxia. It is a scale that evaluates performance in 8 items as walking, standing, sitting, speech disorder, finger tracking, finger-nose test, rapid alternative hand movements, and heel-tibia test. The score range is 0-40, and an increase in the score indicates increased ataxia severity. It is a reliable and valid scale for ataxic MS patients. The assessment will take 15 minutes.
ICARS
时间窗: up to 6 months
It will be used to assessment the severity of ataxia. ICARS consists of 4 sub-titles: posture and gait disorders, kinetic functions, speech disorders, and oculomotor disorders. The score range is in the range of 0-100, and higher scores indicate increased disease severity. It is a reliable and valid scale for ataxic MS patients. The assessment will take 20 minutes.
次要结局
- Montreal Cognitive Assessment (MoCA)(up to 6 months)
- Telehealth Usability Questionnaire(up to 6 months)
- Expanded Disability Status Scale (EDSS)(up to 6 months)
- Telemedicine Satisfaction Questionnaire(up to 6 months)
研究者
Güngör Beyza ÖZVAR
MSc physiotherapist
Hacettepe University