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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: Walk with Me app


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walk with Me app<br> | Device: Walk with Me app<br>* For 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score pre 6-minute walk test (6 MWT) indoor | he instructor will ask the participant to rate their fatigue from 0-10 (0= no fatigue, 10= most fatigued ever) | Baseline | 
| VAS score pre 6-minute walk test (6 MWT) outdoor | he instructor will ask the participant to rate their fatigue from 0-10 (0= no fatigue, 10= most fatigued ever) | Baseline | 
| VAS score pre 6-minute walk test (6 MWT) indoor | he instructor will ask the participant to rate their fatigue from 0-10 (0= no fatigue, 10= most fatigued ever) | week 11 | 
| VAS score pre 6-minute walk test (6 MWT) outdoor | 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). | Baseline | 
| VAS score pre 6-minute walk test (6 MWT) indoor | 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). | week 11 | 
| VAS score pre 6-minute walk test (6 MWT) outdoor | 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). | week 11 | 
| Distance walked index during the 6MWT indoor | 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. | Baseline | 
| Distance walked index during the 6MWT outdoor | 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. | Baseline | 
| Distance walked index during the 6MWT indoor | 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. | week 11 | 
| Distance walked index during the 6MWT outdoor | 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. | week 11 | 
| MSWS-12 score | This is a short questionnaire to map out walking difficulties in daily living. | Baseline | 
| MSWS-12 score | This is a short questionnaire to map out walking difficulties in daily living. | Week 11 | 
| the Paced Auditory Serial Addition Test (PASAT) (Cognitive Fatigability) | 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 | baseline | 
| the Paced Auditory Serial Addition Test (PASAT) (Cognitive Fatigability) | 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 | week 11 | 
| the Symbol Digit Modality Test (SDMT) (Cognitive fatigability) | his is a cognitive performance test, substantiated with focus, speed, and visual scanning. Correct answers last 30 seconds vs first 30 seconds | baseline | 
| the Symbol Digit Modality Test (SDMT) (Cognitive fatigability) | his is a cognitive performance test, substantiated with focus, speed, and visual scanning. Correct answers last 30 seconds vs first 30 seconds | week 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 times sit to stand (5xSTS) (Motor Function test) | This is a motor test to assess the functional lower limb muscle strength. The participant is asked to stand from a seated position and sit down again as fast as possible for five times in a row. | Baseline | 
| 5 times sit to stand (5xSTS) (Motor Function test) | This is a motor test to assess the functional lower limb muscle strength. The participant is asked to stand from a seated position and sit down again as fast as possible for five times in a row. | Week 11 | 
| Timed 25 Foot Walk (T25FW) (Motor Function) | This is a motor test at which the participant is instructed to walk 25 ft (=7,62 meter) as fast and safely as possible. This is a quantitative performance test to assess mobility and leg function. | baseline | 
| Timed 25 Foot Walk (T25FW) (Motor Function) | This is a motor test at which the participant is instructed to walk 25 ft (=7,62 meter) as fast and safely as possible. This is a quantitative performance test to assess mobility and leg function. | week 11 | 
| Nine Hole Peg Test (NHPT) | This is a motor test to assess the participant's manual skills. This test records the time the participant needs to place 9 pins in the pegboard and remove them again. | baseline | 
| Nine Hole Peg Test (NHPT) | This is a motor test to assess the participant's manual skills. This test records the time the participant needs to place 9 pins in the pegboard and remove them again. | week 11 | 
| Modified Fatigue Impact Scale (MFIS) | This is a short questionnaire to evaluate to impact of general fatigue. This questionnaire measures the effects of fatigue on three levels: physical, cognitive and psychosocial. | baseline | 
| Modified Fatigue Impact Scale (MFIS) | This is a short questionnaire to evaluate to impact of general fatigue. This questionnaire measures the effects of fatigue on three levels: physical, cognitive and psychosocial. | Week 11 | 
| Fatigue severity scale (FSS) | This is a short questionnaire to measure the severity of general fatigue. | baseline | 
| Fatigue severity scale (FSS) | This is a short questionnaire to measure the severity of general fatigue. | week 11 | 
| Multiple Sclerosis Impact Scale (MSIS-29) | This is a short self-report questionnaire used to assess the day-to-day life in the past two weeks. This questionnaire has a physical and psychological scale. | baseline | 
| Multiple Sclerosis Impact Scale (MSIS-29) | This is a short self-report questionnaire used to assess the day-to-day life in the past two weeks. This questionnaire has a physical and psychological scale. | week 11 | 
| Health-related quality of life (SF-36) | This is a short questionnaire to measure health status. | baseline | 
| Health-related quality of life (SF-36) | This is a short questionnaire to measure health status. | week 11 | 
| International Physical Activity Questionnaire (IPAQ) | This is a questionnaire to measure health-related physical activity | baseline | 
| International Physical Activity Questionnaire (IPAQ) | This is a questionnaire to measure health-related physical activity | week 11 |