We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: learning and recall of a sequence of body movements Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : December 18, 2018
Actual Primary Completion Date : January 24, 2020
Actual Study Completion Date : January 24, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
persons with Multiple Sclerosis (MS) 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
Healthy controls 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. accuracy [ Time Frame: week 1 ]
    Number of correct sequences uttered, total number of sequences, precisions prior to completing three correct trials.

  2. precision [ Time Frame: week 1 ]
    Number of correct sequences uttered, total number of sequences, precisions prior to completing three correct trials.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03931278


Locations
Layout table for location information
Belgium
University Ghent
Ghent, Belgium, 9000
National MS Center Melsbroek
Melsbroek, Belgium, 1820
Revalidatie en MS Centrum Overpelt
Overpelt, Belgium, 3900
Sponsors and Collaborators
Hasselt University
University Ghent
Revalidatie & MS Centrum Overpelt
National MS Center Melsbroek
Investigators
Layout table for investigator information
Principal Investigator: peter Feys, prof. dr. Hasselt University
Study Chair: lousin Moumdjian Hasselt University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Peter Feys, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier: NCT03931278    
Other Study ID Numbers: SEA-001
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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