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临床试验/NCT04142008
NCT04142008已完成不适用

Walk With Me: a Mobile Application to Improve Walking in Persons With MS

Hasselt University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
2
主要终点
Distance walked index during the 6MWT outdoor

研究概览

简要总结

During 10 weeks the subjects will use a mobile application (Walk with Me). The aim of this study is to investigate the usability of the mobile application, as well as investigating if the mobile application effects walking.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed diagnosis according to the McDonald Criteria
  • Able to walk independently or with unilateral support for 10 minutes

排除标准

  • Exacerbation or relapse within last 3 months before study
  • Other medical condition interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis and fibromyalgia, stroke, Parkinson).

结局指标

主要结局

Distance walked index during the 6MWT outdoor

时间窗: week 11

During this test participants are instructed to walk as far as possible on a 30-meter course for 6 minutes. The distance walked is recorded every minute. The distance of the last minute is compared to the distance walked in the first minute to find the index.

VAS score pre 6-minute walk test (6 MWT) outdoor

时间窗: week 11

Participants will be instructed to perform the 6MWT. After this test the instructor will ask the participant to rate their fatigue from 0-10 (0= no fatigue, 10= most fatigued ever).

Distance walked index during the 6MWT indoor

时间窗: week 11

During this test participants are instructed to walk as far as possible on a 30-meter course for 6 minutes. The distance walked is recorded every minute. The distance of the last minute is compared to the distance walked in the first minute to find the index.

MSWS-12 score

时间窗: Week 11

This is a short questionnaire to map out walking difficulties in daily living.

the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)

时间窗: week 11

his is a cognitive performance test, substantiated with focus, speed, and visual scanning. Correct answers last 30 seconds vs first 30 seconds

the Paced Auditory Serial Addition Test (PASAT) (Cognitive Fatigability)

时间窗: week 11

This is a cognitive test where the participant will try to retain certain numbers they hear and do math. Correct answer last 1/3 vs first 1/3

VAS score pre 6-minute walk test (6 MWT) indoor

时间窗: week 11

he instructor will ask the participant to rate their fatigue from 0-10 (0= no fatigue, 10= most fatigued ever)

次要结局

  • 5 times sit to stand (5xSTS) (Motor Function test)(Week 11)
  • Timed 25 Foot Walk (T25FW) (Motor Function)(week 11)
  • Nine Hole Peg Test (NHPT)(week 11)
  • Modified Fatigue Impact Scale (MFIS)(Week 11)
  • Health-related quality of life (SF-36)(week 11)
  • International Physical Activity Questionnaire (IPAQ)(week 11)
  • Fatigue severity scale (FSS)(week 11)
  • Multiple Sclerosis Impact Scale (MSIS-29)(week 11)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Feys

Principal Investigator

Hasselt University

研究点 (2)

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