Validity and Reliability of the 6-minute Walk Test Over a Distance of 6 Metres in People With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- The 6-minutes Walk Test on 6 Meters
研究概览
简要总结
The objective of this study is to validate a different version of the 6 minutes Walk Test (6minWT), the 6minWT on 6 meters, instead of the 30 meters.
The secondary objectives are to verify the reliability of this new version and to analyze the possible differences between the 6minWT6 and the 6minWT30 (according to speed at half-turn, other parameters: age, gender, height, EDSS score, type of disease, time since relapse).
详细描述
The 6minWT is used by physiotherapists to monitor the walking endurance abilities of multiple sclerosis (MS) patients. The protocol for this test recommends a distance of 30 meters (6minWT30) to perform the test. However, this distance is not always available in practices and patients' homes. The aim of this study is therefore to validate a protocol over a distance of 6 meters (6minWT6) and to evaluate its reliability : intra-evaluator and test-retest.
The project focuses on the population of walking patients with MS. Inclusion: adults, confirmed diagnosis of MS, Expanded Disability Status Scale (EDSS) score 3 to 6.5, or be able to walk 30 metres with or without aids, good understanding of French, have already completed a 6-minute walking test, be able to give consent by signature.
Exclusion: Lung disease, heart disease, co-morbidity preventing 6minWT, relapse in the last 3 months, chronic fatigue ≥ at 8 (Visual Analog Score-Fatigue or Rochester Fatigue Diary).
21 participants will be needed to obtain a good correlation coefficient, which is the objective of the validation of the new version of the 6minWT. The alpha was set at 0.01, the power at 0.9 for a correlation of 0.8.
Each patient will enter the study for one week, corresponding to two visits. The participant will perform the 6minWT6 and the 360 Degree Turn Test the first day and the 6minWT30 followed by the 6minWT6 after up to 45 minutes rest, the second day, a week apart.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •confirmed diagnosis of MS
- •Expanded Disability Status Scale score 3 to 6.5 or to be able to walk 30 meters with or without aids
- •good understanding of French
- •have already completed a 6-minute walk test
- •to be able to give consent by signature
排除标准
- •Lung disease
- •Heart disease
- •co-morbidity preventing 6minWT
- •relapse in the last 3 months
- •chronic fatigue ≥ at 8 (Visual Analog Scale- Fatigue)
结局指标
主要结局
The 6-minutes Walk Test on 6 Meters
时间窗: First test day
The patient walk for 6 minutes back and forth in a 6-meter hallway turning around cones.
次要结局
- 360 Degree Turn Test (Time)(First test day)
- 360 Degree Turn Test (Number of Steps)(First test day)
- 6 Minute Walk Test on 30 Meters(Second test day)
- The 6-minutes Walk Test on 6 Meters(Second test day)