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Completed

NCT Number: NCT04142008

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasselt University

Hasselt, 3500, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Walk with Me app

Device

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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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).

  5. 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).

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. MSWS-12 score

    Time frame: Baseline

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

  12. MSWS-12 score

    Time frame: Week 11

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

  13. 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

  14. 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

  15. 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

  16. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Fatigue severity scale (FSS)

    Time frame: baseline

    This is a short questionnaire to measure the severity of general fatigue.

  10. Fatigue severity scale (FSS)

    Time frame: week 11

    This is a short questionnaire to measure the severity of general fatigue.

  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.

  12. 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.

  13. Health-related quality of life (SF-36)

    Time frame: baseline

    This is a short questionnaire to measure health status.

  14. Health-related quality of life (SF-36)

    Time frame: week 11

    This is a short questionnaire to measure health status.

  15. International Physical Activity Questionnaire (IPAQ)

    Time frame: baseline

    This is a questionnaire to measure health-related physical activity

  16. International Physical Activity Questionnaire (IPAQ)

    Time frame: week 11

    This is a questionnaire to measure health-related physical activity

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 29, 2019
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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