Psychometric Properties of Outcome Measures for Upper Limb Function, in Multiple Sclerosis: a Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Coin rotation task (CRT)
研究概览
简要总结
Current study will investigate de quality (psychometric properties) and clinical utility of several measures of upper limb function, according to disability level. Therefore, several aspects will be inquired:
- Was there an effect of rehabilitation
- Is the measure able to detect change over time? And thus the change exceed measurement error and is it clinically important (responsiveness)
- Does the measure assess what it claims to measure (validity)
- Is the measure able to differentiate all performances of the patients, inclusively the very good and very bad performances (floor and ceiling effects)
- Does the measure gives similar results under consistent test conditions on another testing day (reliability) Worldwide, theoretical approaches to physical therapy and rehabilitation in Multiple Sclerosis often appear significantly different. Since the present research protocol will be performed at different centers across European countries (and US sites), this multi-center study can additionally be applied for mapping the volume and content of rehabilitation, as well as the differential impact of diverse rehabilitation approaches and training volume on mobility, for several disability levels.
Some health-economic analyses will be performed to examine what the approximate cost of rehabilitation compared to effects is and what drivers of costs are (setting, equipment, staff).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of MS according to McDonald criteria
- •a treatment goal to maintain or improve upper limb function
- •no relapse within the last month
- •no changes in disease modifying medication and no corticoid-therapy within the last month
- •receive at least 10 sessions of physical or occupational therapy (in- or outpatient rehabilitation), with a maximum duration of 3 months
排除标准
- •other medical conditions interfering with mobility (e.g. stroke, pregnancy, fractures, …)
- •other neurological impairments with permanent damage (stroke, Parkinson, …)
- •MS-like syndromes such as neuromyelitis optica
- •not able to understand and execute simple instructions
结局指标
主要结局
Coin rotation task (CRT)
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
Visual Analogue Scale muscle weakness
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
Visual Analogue Scale sensory
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
Visual Analogue Scale fatigability
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
Manual Ability Measurement (MAM-36)
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
Performance Scale hand function (PS hand)
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
Nine Hole Peg Test (NHPT)
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
Spasticity 0-10 numeric rating scale (NRS/VAS)
时间窗: day 1, end of study
Visual Analogue Scale coordination
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
Upper Extremity Motor Activity Log (EU-MAL)
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
Pinch strength
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
Box and Block Test (BBT)
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
ABILHAND scale
时间窗: day 1, end of study
a measure of manual ability for adults with upper limb impairment
次要结局
- International Physical Activity Questionnaire (IPAQ)(day 1 and at the end of the rehabilitation, an expected average of three months)
- Hand grip strength (JAMAR)(day 1 and at the end of the rehabilitation, an expected average of three months)
- Fatigability: plate tapping test(day 1 and at the end of the rehabilitation, an expected average of three months)
- Action Research Arm test (ARAT) for patients with NHPT ≤0.27 peg/s (33.3 sec)(day 1 and at the end of the rehabilitation, an expected average of three months)
- Trunk Impairment Scale modified Norwegian version (TIS-modNV)(day 1 and at the end of the rehabilitation, an expected average of three months)
研究者
Peter Feys
prof. dr.
Hasselt University