Sonification Embodied Associations

• Sponsor: Hasselt University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03931278
• Collaborator: University Ghent (Other), Revalidatie & MS Centrum Overpelt (Other), National MS Center Melsbroek (Other)
• Enrollment: 62
• Locations: 3
• Arms: 2
• Actual Duration (Months): 13.2
• Patients Per Site: 20.7
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Dec 18, 2018
• Actual Primary Completion Date: Jan 24, 2020
• Actual Study Completion Date: Jan 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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
Other: 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

Primary Outcome Measures

1. accuracy [week 1]

   Number of correct sequences uttered, total number of sequences, precisions prior to completing three correct trials.

2. precision [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University Ghent	Ghent		Belgium	9000
2	National MS Center Melsbroek	Melsbroek		Belgium	1820
3	Revalidatie en MS Centrum Overpelt	Overpelt		Belgium	3900

Sponsors and Collaborators

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

Investigators

• Principal Investigator: peter Feys, prof. dr., Hasselt University
• Study Chair: lousin Moumdjian, Hasselt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Feys, Principal Investigator, Hasselt University
• ClinicalTrials.gov Identifier: NCT03931278
• Other Study ID Numbers: SEA-001
• First Posted: Apr 30, 2019
• Last Update Posted: May 27, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis

Study Results

No Results Posted as of May 27, 2020