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Completed

NCT Number: NCT03281330

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

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.

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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–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Ghent, Ghent, Belgium

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Who can participate

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

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

Treatment and study plan

auditory cues and music during walking

Behavioral

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 outcomes

  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 outcomes

  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'.

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • National MS Center Melsbroek
  • Revalidatie & MS Centrum Overpelt
  • University Ghent

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2017
Registry last updated
Aug 3, 2018

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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