Clinical trial NCT04142008: Walk With Me: a Mobile Application to Improve Walking in Persons With MS
Official title: Walk With Me: a Mobile Application to Improve Walking in Persons With MS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: VAS score pre 6-minute walk test (6 MWT) indoor
timeFrame: Baseline
measure: VAS score pre 6-minute walk test (6 MWT) outdoor
timeFrame: Baseline
measure: VAS score pre 6-minute walk test (6 MWT) indoor
timeFrame: week 11
measure: VAS score pre 6-minute walk test (6 MWT) outdoor
timeFrame: Baseline
measure: VAS score pre 6-minute walk test (6 MWT) indoor
timeFrame: week 11
measure: VAS score pre 6-minute walk test (6 MWT) outdoor
timeFrame: week 11
measure: Distance walked index during the 6MWT indoor
timeFrame: Baseline
measure: Distance walked index during the 6MWT outdoor
timeFrame: Baseline
measure: Distance walked index during the 6MWT indoor
timeFrame: week 11
measure: Distance walked index during the 6MWT outdoor
timeFrame: week 11
measure: MSWS-12 score
timeFrame: Baseline
measure: MSWS-12 score
timeFrame: Week 11
measure: the Paced Auditory Serial Addition Test (PASAT) (Cognitive Fatigability)
timeFrame: baseline
measure: the Paced Auditory Serial Addition Test (PASAT) (Cognitive Fatigability)
timeFrame: week 11
measure: the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)
timeFrame: baseline
measure: the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)
timeFrame: week 11
Secondary outcomes:
measure: 5 times sit to stand (5xSTS) (Motor Function test)
timeFrame: Baseline
measure: 5 times sit to stand (5xSTS) (Motor Function test)
timeFrame: Week 11
measure: Timed 25 Foot Walk (T25FW) (Motor Function)
timeFrame: baseline
measure: Timed 25 Foot Walk (T25FW) (Motor Function)
timeFrame: week 11
measure: Nine Hole Peg Test (NHPT)
timeFrame: baseline
measure: Nine Hole Peg Test (NHPT)
timeFrame: week 11
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: baseline
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Week 11
measure: Fatigue severity scale (FSS)
timeFrame: baseline
measure: Fatigue severity scale (FSS)
timeFrame: week 11
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: baseline
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: week 11
measure: Health-related quality of life (SF-36)
timeFrame: baseline
measure: Health-related quality of life (SF-36)
timeFrame: week 11
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: baseline
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: week 11
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
Study officials:
affiliation: Hasselt University
name: peter Feys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Fanny Van Geel, drs.
role: STUDY_CHAIR
References: