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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Device: Walk with Me app

• Registration Number: NCT04142008
• Lead Sponsor: Hasselt University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2019-08-31
• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-29
• Study Completion: 2019-12-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-20
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Walk with Me app	Walk with Me app	-

Primary Outcome Measures

Name	Time	Method
VAS score pre 6-minute walk test (6 MWT) indoor	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).
VAS score pre 6-minute walk test (6 MWT) outdoor	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	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	Week 11	This is a short questionnaire to map out walking difficulties in daily living.
Distance walked index during the 6MWT outdoor	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.
the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)	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)	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

Secondary Outcome Measures

Name	Time	Method
5 times sit to stand (5xSTS) (Motor Function test)	Week 11	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.
Timed 25 Foot Walk (T25FW) (Motor Function)	week 11	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.
Nine Hole Peg Test (NHPT)	week 11	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.
Modified Fatigue Impact Scale (MFIS)	Week 11	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.
Health-related quality of life (SF-36)	week 11	This is a short questionnaire to measure health status.
International Physical Activity Questionnaire (IPAQ)	week 11	This is a questionnaire to measure health-related physical activity
Fatigue severity scale (FSS)	week 11	This is a short questionnaire to measure the severity of general fatigue.
Multiple Sclerosis Impact Scale (MSIS-29)	week 11	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.

Trial Locations

Locations (1)

Hasselt University; 🇧🇪 Hasselt, Belgium