NCT04142008

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

12 months

First QC Date

October 25, 2019

Last Update Submit

May 20, 2020

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (16)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • MSWS-12 score

    This is a short questionnaire to map out walking difficulties in daily living.

    Baseline

  • MSWS-12 score

    This is a short questionnaire to map out walking difficulties in daily living.

    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

    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

    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

    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

    week 11

Secondary Outcomes (16)

  • 5 times sit to stand (5xSTS) (Motor Function test)

    Baseline

  • 5 times sit to stand (5xSTS) (Motor Function test)

    Week 11

  • Timed 25 Foot Walk (T25FW) (Motor Function)

    baseline

  • Timed 25 Foot Walk (T25FW) (Motor Function)

    week 11

  • Nine Hole Peg Test (NHPT)

    baseline

  • +11 more secondary outcomes

Study Arms (1)

Walk with Me app

EXPERIMENTAL
Device: Walk with Me app

Interventions

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

Walk with Me app

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis according to the McDonald Criteria
  • Able to walk independently or with unilateral support for 10 minutes

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • peter Feys, prof. dr.

    Hasselt University

    PRINCIPAL INVESTIGATOR

  • Fanny Van Geel, drs.

    Hasselt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2019

First Posted

October 29, 2019

Study Start

September 1, 2018

Primary Completion

August 31, 2019

Study Completion

December 31, 2019

Last Updated

May 21, 2020

Record last verified: 2020-05

Locations

BE(1)