Back to resultsWalk With Me: a Mobile Application to Improve Walking in Persons With MS
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Walk with Me app
Sponsored by
About this trial
This is an interventional other trial for Multiple Sclerosis
Eligibility Criteria
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).
Sites / Locations
- Hasselt University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Walk with Me app
Arm Description
Outcomes
Primary Outcome Measures
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)
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)
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)
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).
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).
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).
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.
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.
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.
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.
MSWS-12 score
This is a short questionnaire to map out walking difficulties in daily living.
MSWS-12 score
This is a short questionnaire to map out walking difficulties in daily living.
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
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
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
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
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Fatigue severity scale (FSS)
This is a short questionnaire to measure the severity of general fatigue.
Fatigue severity scale (FSS)
This is a short questionnaire to measure the severity of general fatigue.
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.
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.
Health-related quality of life (SF-36)
This is a short questionnaire to measure health status.
Health-related quality of life (SF-36)
This is a short questionnaire to measure health status.
International Physical Activity Questionnaire (IPAQ)
This is a questionnaire to measure health-related physical activity
International Physical Activity Questionnaire (IPAQ)
This is a questionnaire to measure health-related physical activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04142008
Brief Title
Walk With Me: a Mobile Application to Improve Walking in Persons With MS
Official Title
Walk With Me: a Mobile Application to Improve Walking in Persons With MS
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Walk with Me app
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Walk with Me app
Intervention Description
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
Primary Outcome Measure Information:
Title
VAS score pre 6-minute walk test (6 MWT) indoor
Description
he instructor will ask the participant to rate their fatigue from 0-10 (0= no fatigue, 10= most fatigued ever)
Time Frame
Baseline
Title
VAS score pre 6-minute walk test (6 MWT) outdoor
Description
he instructor will ask the participant to rate their fatigue from 0-10 (0= no fatigue, 10= most fatigued ever)
Time Frame
Baseline
Title
VAS score pre 6-minute walk test (6 MWT) indoor
Description
he instructor will ask the participant to rate their fatigue from 0-10 (0= no fatigue, 10= most fatigued ever)
Time Frame
week 11
Title
VAS score pre 6-minute walk test (6 MWT) outdoor
Description
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).
Time Frame
Baseline
Title
VAS score pre 6-minute walk test (6 MWT) indoor
Description
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).
Time Frame
week 11
Title
VAS score pre 6-minute walk test (6 MWT) outdoor
Description
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).
Time Frame
week 11
Title
Distance walked index during the 6MWT indoor
Description
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.
Time Frame
Baseline
Title
Distance walked index during the 6MWT outdoor
Description
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.
Time Frame
Baseline
Title
Distance walked index during the 6MWT indoor
Description
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.
Time Frame
week 11
Title
Distance walked index during the 6MWT outdoor
Description
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.
Time Frame
week 11
Title
MSWS-12 score
Description
This is a short questionnaire to map out walking difficulties in daily living.
Time Frame
Baseline
Title
MSWS-12 score
Description
This is a short questionnaire to map out walking difficulties in daily living.
Time Frame
Week 11
Title
the Paced Auditory Serial Addition Test (PASAT) (Cognitive Fatigability)
Description
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
Time Frame
baseline
Title
the Paced Auditory Serial Addition Test (PASAT) (Cognitive Fatigability)
Description
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
Time Frame
week 11
Title
the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)
Description
his is a cognitive performance test, substantiated with focus, speed, and visual scanning. Correct answers last 30 seconds vs first 30 seconds
Time Frame
baseline
Title
the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)
Description
his is a cognitive performance test, substantiated with focus, speed, and visual scanning. Correct answers last 30 seconds vs first 30 seconds
Time Frame
week 11
Secondary Outcome Measure Information:
Title
5 times sit to stand (5xSTS) (Motor Function test)
Description
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.
Time Frame
Baseline
Title
5 times sit to stand (5xSTS) (Motor Function test)
Description
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.
Time Frame
Week 11
Title
Timed 25 Foot Walk (T25FW) (Motor Function)
Description
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.
Time Frame
baseline
Title
Timed 25 Foot Walk (T25FW) (Motor Function)
Description
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.
Time Frame
week 11
Title
Nine Hole Peg Test (NHPT)
Description
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.
Time Frame
baseline
Title
Nine Hole Peg Test (NHPT)
Description
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.
Time Frame
week 11
Title
Modified Fatigue Impact Scale (MFIS)
Description
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.
Time Frame
baseline
Title
Modified Fatigue Impact Scale (MFIS)
Description
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.
Time Frame
Week 11
Title
Fatigue severity scale (FSS)
Description
This is a short questionnaire to measure the severity of general fatigue.
Time Frame
baseline
Title
Fatigue severity scale (FSS)
Description
This is a short questionnaire to measure the severity of general fatigue.
Time Frame
week 11
Title
Multiple Sclerosis Impact Scale (MSIS-29)
Description
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.
Time Frame
baseline
Title
Multiple Sclerosis Impact Scale (MSIS-29)
Description
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.
Time Frame
week 11
Title
Health-related quality of life (SF-36)
Description
This is a short questionnaire to measure health status.
Time Frame
baseline
Title
Health-related quality of life (SF-36)
Description
This is a short questionnaire to measure health status.
Time Frame
week 11
Title
International Physical Activity Questionnaire (IPAQ)
Description
This is a questionnaire to measure health-related physical activity
Time Frame
baseline
Title
International Physical Activity Questionnaire (IPAQ)
Description
This is a questionnaire to measure health-related physical activity
Time Frame
week 11
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
peter Feys, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fanny Van Geel, drs.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Hasselt University
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Walk With Me: a Mobile Application to Improve Walking in Persons With MS
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