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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • 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

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
Intervention / Treatment
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

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

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

Hasselt University

Investigators

  • 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)

September 1, 2018

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

October 25, 2019

First Submitted That Met QC Criteria

October 25, 2019

First Posted (Actual)

October 29, 2019

Study Record Updates

Last Update Posted (Actual)

May 21, 2020

Last Update Submitted That Met QC Criteria

May 20, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

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