Psychometric Properties of Mobility, Beyond Walking Speed, 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
- 254
- 试验地点
- 2
- 主要终点
- 5 repetition sit-to-stand test (5STS-test)
研究概览
简要总结
Current study will investigate the quality (psychometric properties) and clinical utility of several mobility measures, 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
- 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 criteria24,
- •Expanded Disability Status Scale25 (EDSS) ≥ 2 and ≤ 6.5 as determined by neurologists or trained clinician
- •no relapse within the last month
- •no changes in disease modifying treatment and no corticoid-therapy within the last month
- •receive at least 10 sessions of physical 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
5 repetition sit-to-stand test (5STS-test)
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
Modified 5 repetition sit-to-stand test (mod 5STS-test)
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
Rivermead Mobility Index (RMI)
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
Multiple Sclerosis Walking Scale-12 (MSWS-12)
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
Timed 25-Foot Walk test (T25FW)
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
Timed up and go (TUG), TUGcognitive
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
Four Square Step Test (FSST)
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
Two minute walk test (2MWT)
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
Performance Scale mobility (PS-mob)
时间窗: day 1 and at the end of the rehabilitation, an expected average of three months
次要结局
- Timed Up and Go, manual(day 1 and at the end of the rehabilitation, an expected average of three months)
- Berg Balance Scale (BBS)(day 1 and at the end of the rehabilitation, an expected average of three months)
- Dynamic Gait index (DGI)(day 1 and at the end of the rehabilitation, an expected average of three months)
- Activities-specific Balance Confidence Scale (ABC)(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)
- International Physical Activity Questionnaire (IPAQ)(day 1 and at the end of the rehabilitation, an expected average of three months)
研究者
Peter Feys
prof. dr.
Hasselt University