Multiple SclerosisNCT04142008
Walk With Me: a Mobile Application to Improve Walking in Persons With MS
A study testing Walk with Me app in people with Multiple Sclerosis, run by Hasselt University at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Walk with Me app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis according to the McDonald Criteria
- Able to walk independently or with unilateral support for 10 minutes
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Walk with Me app
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk with Me appDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Walk with Me app | Experimental | Not described Receives: Device: Walk with Me app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
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)
Measured: Baseline
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)
Measured: week 11
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).
Measured: Baseline
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).
Measured: week 11
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).
Measured: week 11
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: week 11
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.
Measured: week 11
MSWS-12 score
This is a short questionnaire to map out walking difficulties in daily living.
Measured: Baseline
MSWS-12 score
This is a short questionnaire to map out walking difficulties in daily living.
Measured: Week 11
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
Measured: baseline
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
Measured: week 11
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
Measured: baseline
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
Measured: week 11
Secondary outcomes (16)
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.
Measured: Baseline
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.
Measured: Week 11
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.
Measured: baseline
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.
Measured: week 11
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.
Measured: baseline
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.
Measured: week 11
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.
Measured: baseline
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.
Measured: Week 11
Fatigue severity scale (FSS)
This is a short questionnaire to measure the severity of general fatigue.
Measured: baseline
Fatigue severity scale (FSS)
This is a short questionnaire to measure the severity of general fatigue.
Measured: week 11
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.
Measured: baseline
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.
Measured: week 11
Health-related quality of life (SF-36)
This is a short questionnaire to measure health status.
Measured: baseline
Health-related quality of life (SF-36)
This is a short questionnaire to measure health status.
Measured: week 11
International Physical Activity Questionnaire (IPAQ)
This is a questionnaire to measure health-related physical activity
Measured: baseline
International Physical Activity Questionnaire (IPAQ)
This is a questionnaire to measure health-related physical activity
Measured: week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start1 Sep 2018
- Primary completion31 Aug 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
- Investigators
- peter Feys, prof. dr., Principal investigator, Hasselt UniversityFanny Van Geel, drs., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142008
- Sponsor's protocol ID
- B9115201836734
- Status last verified
- May 2020
- First submitted
- 25 Oct 2019
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walk With Me: a Mobile Application to Improve Walking in Persons With MS
- ClinicalTrials.gov ID
- NCT04142008
- Acronym / sponsor ID
- B9115201836734
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Walk with Me app | Experimental | Device: Walk with Me app |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis according to the McDonald Criteria
- Able to walk independently or with unilateral support for 10 minutes
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walk with Me appFor 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 | Device | Walk with Me app |
Primary outcome
VAS score pre 6-minute walk test (6 MWT) indoor
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: week 11
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
Time frame: Baseline
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
Time frame: 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
Time frame: 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
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: 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.
Distance walked index during the 6MWT outdoor
Time frame: 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
Time frame: Baseline
This is a short questionnaire to map out walking difficulties in daily living.
MSWS-12 score
Time frame: Week 11
This is a short questionnaire to map out walking difficulties in daily living.
the Paced Auditory Serial Addition Test (PASAT) (Cognitive Fatigability)
Time frame: baseline
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)
Time frame: 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
the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)
Time frame: baseline
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)
Time frame: week 11
his is a cognitive performance test, substantiated with focus, speed, and visual scanning. Correct answers last 30 seconds vs first 30 seconds
16 secondary outcomes
5 times sit to stand (5xSTS) (Motor Function test)
Time frame: Baseline
5 times sit to stand (5xSTS) (Motor Function test)
Time frame: Week 11
Timed 25 Foot Walk (T25FW) (Motor Function)
Time frame: baseline
Timed 25 Foot Walk (T25FW) (Motor Function)
Time frame: week 11
Nine Hole Peg Test (NHPT)
Time frame: baseline
Nine Hole Peg Test (NHPT)
Time frame: week 11
Modified Fatigue Impact Scale (MFIS)
Time frame: baseline
Modified Fatigue Impact Scale (MFIS)
Time frame: Week 11
Fatigue severity scale (FSS)
Time frame: baseline
Fatigue severity scale (FSS)
Time frame: week 11
Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: baseline
Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: week 11
Health-related quality of life (SF-36)
Time frame: baseline
Health-related quality of life (SF-36)
Time frame: week 11
International Physical Activity Questionnaire (IPAQ)
Time frame: baseline
International Physical Activity Questionnaire (IPAQ)
Time frame: week 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
peter Feys, prof. dr. principal investigator
Hasselt University
Fanny Van Geel, drs. study chair
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk with Me app in people with Multiple Sclerosis, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score pre 6-minute walk test (6 MWT) indoor (time frame: Baseline). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.