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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04142008
• Other study ID #: B9115201836734
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2020
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Device:
• Walk with Me app
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

Locations

Country	Name	City	State
Belgium	Hasselt University	Hasselt

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	MSWS-12 score	This is a short questionnaire to map out walking difficulties in daily living.	Baseline
Primary	MSWS-12 score	This is a short questionnaire to map out walking difficulties in daily living.	Week 11
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Fatigue severity scale (FSS)	This is a short questionnaire to measure the severity of general fatigue.	baseline
Secondary	Fatigue severity scale (FSS)	This is a short questionnaire to measure the severity of general fatigue.	week 11
Secondary	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
Secondary	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
Secondary	Health-related quality of life (SF-36)	This is a short questionnaire to measure health status.	baseline
Secondary	Health-related quality of life (SF-36)	This is a short questionnaire to measure health status.	week 11
Secondary	International Physical Activity Questionnaire (IPAQ)	This is a questionnaire to measure health-related physical activity	baseline
Secondary	International Physical Activity Questionnaire (IPAQ)	This is a questionnaire to measure health-related physical activity	week 11