- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03931278
Sonification Embodied Associations
May 24, 2020 updated by: Peter Feys, Hasselt University
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ghent, Belgium, 9000
- University Ghent
-
Melsbroek, Belgium, 1820
- National MS Center Melsbroek
-
Overpelt, Belgium, 3900
- Revalidatie en MS Centrum Overpelt
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Healthy controls
|
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
|
|
Other: persons with Multiple Sclerosis (MS)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
accuracy
Time Frame: week 1
|
Number of correct sequences uttered, total number of sequences, precisions prior to completing three correct trials.
|
week 1
|
|
precision
Time Frame: week 1
|
Number of correct sequences uttered, total number of sequences, precisions prior to completing three correct trials.
|
week 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
week 1
|
|
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.
|
week 1
|
|
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.
|
week 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: lousin Moumdjian, Hasselt University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 18, 2018
Primary Completion (Actual)
January 24, 2020
Study Completion (Actual)
January 24, 2020
Study Registration Dates
First Submitted
April 25, 2019
First Submitted That Met QC Criteria
April 25, 2019
First Posted (Actual)
April 30, 2019
Study Record Updates
Last Update Posted (Actual)
May 27, 2020
Last Update Submitted That Met QC Criteria
May 24, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SEA-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.