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Sonification Embodied Associations

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

learning and recall of a sequence of body movements

About this trial

This is an interventional other trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University Ghent
National MS Center Melsbroek
Revalidatie en MS Centrum Overpelt

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

persons with Multiple Sclerosis (MS)

Healthy controls

Arm Description

Outcomes

Primary Outcome Measures

accuracy

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

precision

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

Secondary Outcome Measures

Inter Step intervals

The technology used can log time data. Therefore, the inter-step intervals can be calculated from the logged data.

Inter Stride intervals

The technology used can log time data. Therefore, the inter stride intervals can be calculated from the logged data.

step duration on the tile

The technology used can log time data. Therefore, the total time that each foot is placed on the tiles can be derived.

Full Information

NCT ID

NCT03931278

First Posted

April 25, 2019

Last Updated

May 24, 2020

Sponsor

Hasselt University

Collaborators

University Ghent, Revalidatie & MS Centrum Overpelt, National MS Center Melsbroek

1. Study Identification

Unique Protocol Identification Number

NCT03931278

Brief Title

Sonification Embodied Associations

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

December 18, 2018 (Actual)

Primary Completion Date

January 24, 2020 (Actual)

Study Completion Date

January 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hasselt University

Collaborators

University Ghent, Revalidatie & MS Centrum Overpelt, National MS Center Melsbroek

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

persons with Multiple Sclerosis (MS)

Arm Type

Other

Arm Title

Healthy controls

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

learning and recall of a sequence of body movements

Intervention Description

Primary Outcome Measure Information:

Title

accuracy

Description

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

Time Frame

week 1

Title

precision

Description

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

Time Frame

week 1

Secondary Outcome Measure Information:

Title

Inter Step intervals

Description

The technology used can log time data. Therefore, the inter-step intervals can be calculated from the logged data.

Time Frame

week 1

Title

Inter Stride intervals

Description

The technology used can log time data. Therefore, the inter stride intervals can be calculated from the logged data.

Time Frame

week 1

Title

step duration on the tile

Description

The technology used can log time data. Therefore, the total time that each foot is placed on the tiles can be derived.

Time Frame

week 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

peter Feys, prof. dr.

Organizational Affiliation

Hasselt University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

lousin Moumdjian

Organizational Affiliation

Hasselt University

Official's Role

Study Chair

Facility Information:

Facility Name

University Ghent

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

National MS Center Melsbroek

City

Melsbroek

ZIP/Postal Code

1820

Country

Belgium

Facility Name

Revalidatie en MS Centrum Overpelt

City

Overpelt

ZIP/Postal Code

3900

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Sonification Embodied Associations

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