Multiple Sclerosis Clinical Trial
Official title:
Walk With Me: a Mobile Application to Improve Walking in Persons With MS
Verified date | May 2020 |
Source | Hasselt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
Belgium | Hasselt University | Hasselt |
Lead Sponsor | Collaborator |
---|---|
Hasselt University |
Belgium,
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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