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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04142008
Other study ID # B9115201836734
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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