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

May 20, 2020 updated by: Peter Feys, Hasselt University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Hasselt, Belgium, 3500
        • Hasselt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Walk with Me app
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline
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)
Baseline
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)
week 11
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).
Baseline
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).
week 11
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).
week 11
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.
Baseline
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.
Baseline
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.
week 11
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.
week 11
MSWS-12 score
Time Frame: Baseline
This is a short questionnaire to map out walking difficulties in daily living.
Baseline
MSWS-12 score
Time Frame: Week 11
This is a short questionnaire to map out walking difficulties in daily living.
Week 11
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
baseline
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
week 11
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
baseline
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
week 11

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
5 times sit to stand (5xSTS) (Motor Function test)
Time Frame: Baseline
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
5 times sit to stand (5xSTS) (Motor Function test)
Time Frame: Week 11
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
Timed 25 Foot Walk (T25FW) (Motor Function)
Time Frame: baseline
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
Timed 25 Foot Walk (T25FW) (Motor Function)
Time Frame: week 11
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
Nine Hole Peg Test (NHPT)
Time Frame: baseline
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
Nine Hole Peg Test (NHPT)
Time Frame: week 11
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
Modified Fatigue Impact Scale (MFIS)
Time Frame: baseline
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
Modified Fatigue Impact Scale (MFIS)
Time Frame: Week 11
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
Fatigue severity scale (FSS)
Time Frame: baseline
This is a short questionnaire to measure the severity of general fatigue.
baseline
Fatigue severity scale (FSS)
Time Frame: week 11
This is a short questionnaire to measure the severity of general fatigue.
week 11
Multiple Sclerosis Impact Scale (MSIS-29)
Time Frame: baseline
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
Multiple Sclerosis Impact Scale (MSIS-29)
Time Frame: week 11
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
Health-related quality of life (SF-36)
Time Frame: baseline
This is a short questionnaire to measure health status.
baseline
Health-related quality of life (SF-36)
Time Frame: week 11
This is a short questionnaire to measure health status.
week 11
International Physical Activity Questionnaire (IPAQ)
Time Frame: baseline
This is a questionnaire to measure health-related physical activity
baseline
International Physical Activity Questionnaire (IPAQ)
Time Frame: week 11
This is a questionnaire to measure health-related physical activity
week 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasselt University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Fanny Van Geel, drs., Hasselt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B9115201836734

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings