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Sonification Embodied Associations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03931278
Recruitment Status : Completed
First Posted : April 30, 2019
Last Update Posted : May 27, 2020
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  ICMJE April 25, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date May 27, 2020
Actual Study Start Date  ICMJE December 18, 2018
Actual Primary Completion Date January 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • accuracy [ Time Frame: week 1 ]
    Number of correct sequences uttered, total number of sequences, precisions prior to completing three correct trials.
  • precision [ Time Frame: week 1 ]
    Number of correct sequences uttered, total number of sequences, precisions prior to completing three correct trials.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • Inter Step intervals [ Time Frame: week 1 ]
    The technology used can log time data. Therefore, the inter-step intervals can be calculated from the logged data.
  • Inter Stride intervals [ Time Frame: week 1 ]
    The technology used can log time data. Therefore, the inter stride intervals can be calculated from the logged data.
  • step duration on the tile [ Time Frame: week 1 ]
    The technology used can log time data. Therefore, the total time that each foot is placed on the tiles can be derived.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sonification Embodied Associations
Official Title  ICMJE Investigating Auditory Sonification (Melodic and Single Tones) and Visual Real-time Feedback as a Tool for Embodied Associations, and Its Effects on Learning and Balance in Persons With Multiple Sclerosis
Brief Summary The objective of this study to investigate, if learning and recall of a sequence of body movements (steps that realize a pattern on the ground) can be improved by self-produced music (having particular melodic-structures in relation to the pattern), compared to the same sound (a single tone) for each pattern in persons with multiple sclerosis compared to age and gender matched controls
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Other: learning and recall of a sequence of body movements
The objective of this study to investigate, if learning and recall of a sequence of body movements (steps that realize a pattern on the ground) can be improved by self-produced music (having particular melodic-structures in relation to the pattern), compared to the same sound (a single tone) for each pattern in persons
Study Arms  ICMJE
  • persons with Multiple Sclerosis (MS)
    Intervention: Other: learning and recall of a sequence of body movements
  • Healthy controls
    Intervention: Other: learning and recall of a sequence of body movements
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2020)		 62
Original Estimated Enrollment  ICMJE
 (submitted: April 25, 2019)		 60
Actual Study Completion Date  ICMJE January 24, 2020
Actual Primary Completion Date January 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Time up and Go (TUG) test: 8 sec -- > 21 sec

Exclusion Criteria:

  • cognitive impairment hindering the understanding and execution of the experimental procedures,
  • pregnancy,
  • hearing impairment,
  • amusia
  • beat deafness,
  • colour blindness.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03931278
Other Study ID Numbers  ICMJE SEA-001
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  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Peter Feys, Hasselt University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hasselt University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University Ghent
  • Revalidatie & MS Centrum Overpelt
  • National MS Center Melsbroek
Investigators  ICMJE
Principal Investigator: peter Feys, prof. dr. Hasselt University
Study Chair: lousin Moumdjian Hasselt University
PRS Account Hasselt University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP