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Effect of Motor Entrainment to Auditory Cues and Music During Walking on Quality of Movement and Perceived Fatigue in Persons With Multiple Sclerosis (PwMS)

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ClinicalTrials.gov Identifier: NCT03281330
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : August 3, 2018
Sponsor:
Collaborators:
University Ghent
Revalidatie & MS Centrum Overpelt
National MS Center Melsbroek
Information provided by (Responsible Party):
Peter Feys, Hasselt University

Brief Summary:
The study investigates the effect of different conditions of auditory cueing and music on walking quality and perceived fatigue in persons with multiple sclerosis compared to healthy controls. The study extends over a four session period, each session lasting maximally 1h30 minutes The experimental conditions include participants walking to music and metronome (at different tempi) for 3minutes and 15 seconds per condition, with a rest period of 3 minutes in between each condition. Non-invasive equipment will be used. participants are equipped with sensors (watch-like straps at the wrists, ankles and across the chest) and are given wireless headphones.

Condition or disease Intervention/treatment
Multiple Sclerosis Behavioral: auditory cues and music during walking

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Motor Entrainment to Auditory Cues and Music During Walking on Quality of Movement and Perceived Fatigue in Persons With Multiple Sclerosis (PwMS)
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
persons with Multiple Sclerosis Behavioral: auditory cues and music during walking
the effect of different conditions of auditory cueing and music on walking quality and perceived fatigue in persons with multiple sclerosis compared to healthy controls

Healthy controls Behavioral: auditory cues and music during walking
the effect of different conditions of auditory cueing and music on walking quality and perceived fatigue in persons with multiple sclerosis compared to healthy controls




Primary Outcome Measures :
  1. Spatio-temporal parameters of gait [ Time Frame: day 1 ]
    Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.

  2. Spatio-temporal parameters of gait [ Time Frame: week 1 ]
    Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.

  3. Spatio-temporal parameters of gait [ Time Frame: week 2 ]
    Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.

  4. Spatio-temporal parameters of gait [ Time Frame: week 3 ]
    Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.

  5. Parameter's of sychronisation [ Time Frame: day 1 ]
    Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters

  6. Parameter's of sychronisation [ Time Frame: week 1 ]
    Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters

  7. Parameter's of sychronisation [ Time Frame: week 2 ]
    Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters

  8. Parameter's of sychronisation [ Time Frame: week 3 ]
    Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters


Secondary Outcome Measures :
  1. subjective physical /mental fatigue [ Time Frame: day 1 ]
    After each experimental condition, the participant is asked 'how tired do you feel in your body on a scale of 0 to 10, 0 being not tired at all and 10 being exhausted'

  2. subjective physical /mental fatigue [ Time Frame: week 1 ]
    After each experimental condition, the participant is asked 'how tired do you feel in your body on a scale of 0 to 10, 0 being not tired at all and 10 being exhausted'

  3. subjective physical /mental fatigue [ Time Frame: week 2 ]
    After each experimental condition, the participant is asked 'how tired do you feel in your body on a scale of 0 to 10, 0 being not tired at all and 10 being exhausted'

  4. physical /mental fatigue [ Time Frame: week 3 ]
    After each experimental condition, the participant is asked 'how tired do you feel in your body on a scale of 0 to 10, 0 being not tired at all and 10 being exhausted'

  5. motivation [ Time Frame: day 1 ]
    he participants is asked: 'how motivating was it to walk to the last particular stimuli (in the metronome condition)/Song (in the music condition) on a scale of 0-5. ) being not motivating at all and 5 being very motivating'.

  6. motivation [ Time Frame: week 1 ]
    he participants is asked: 'how motivating was it to walk to the last particular stimuli (in the metronome condition)/Song (in the music condition) on a scale of 0-5. ) being not motivating at all and 5 being very motivating'.

  7. motivation [ Time Frame: week 2 ]
    he participants is asked: 'how motivating was it to walk to the last particular stimuli (in the metronome condition)/Song (in the music condition) on a scale of 0-5. ) being not motivating at all and 5 being very motivating'.

  8. motivation [ Time Frame: week 3 ]
    he participants is asked: 'how motivating was it to walk to the last particular stimuli (in the metronome condition)/Song (in the music condition) on a scale of 0-5. ) being not motivating at all and 5 being very motivating'.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
persons with Multiple Sclerosis and healthy volonteers
Criteria

Inclusion Criteria:

  • diagnosis of MS of >1 year,
  • no relapse in the last 1 month,
  • ability to walk for 12 minutes without interruption,
  • an average usual walking speed between the range of 0.4 and 1.2 m/s.

Exclusion Criteria:

  • cognitive impairment hindering the understanding and execution of the experimental procedures
  • pregnancy
  • hearing impairment
  • amusia
  • beat deafness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281330


Locations
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Belgium
University of Ghent
Gent, Belgium
Nationaal Multiple Sclerose Center
Melsbroek, Belgium
Revalidatie & MS Centrum Overpelt
Overpelt, Belgium
Sponsors and Collaborators
Hasselt University
University Ghent
Revalidatie & MS Centrum Overpelt
National MS Center Melsbroek
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Responsible Party: Peter Feys, prof. dr., Hasselt University
ClinicalTrials.gov Identifier: NCT03281330    
Other Study ID Numbers: B67021629797
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases