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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

Tracking Information
First Submitted Date September 11, 2017
First Posted Date September 13, 2017
Last Update Posted Date August 3, 2018
Actual Study Start Date February 1, 2017
Actual Primary Completion Date May 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 11, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 11, 2017)
  • 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'
  • 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'
  • 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'
  • 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'
  • 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'.
  • 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'.
  • 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'.
  • 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'.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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)
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)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population persons with Multiple Sclerosis and healthy volonteers
Condition Multiple Sclerosis
Intervention 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
Study Groups/Cohorts
  • persons with Multiple Sclerosis
    Intervention: Behavioral: auditory cues and music during walking
  • Healthy controls
    Intervention: Behavioral: auditory cues and music during walking
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 11, 2017)
60
Original Estimated Enrollment Same as current
Actual Study Completion Date June 30, 2018
Actual Primary Completion Date May 30, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT03281330
Other Study ID Numbers B67021629797
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Peter Feys, Hasselt University
Study Sponsor Hasselt University
Collaborators
  • University Ghent
  • Revalidatie & MS Centrum Overpelt
  • National MS Center Melsbroek
Investigators Not Provided
PRS Account Hasselt University
Verification Date August 2018