NCT03931278

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2020

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

1.1 years

First QC Date

April 25, 2019

Last Update Submit

May 24, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • accuracy

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

    week 1

  • precision

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

    week 1

Secondary Outcomes (3)

  • Inter Step intervals

    week 1

  • Inter Stride intervals

    week 1

  • step duration on the tile

    week 1

Study Arms (2)

persons with Multiple Sclerosis (MS)

OTHER
Other: learning and recall of a sequence of body movements

Healthy controls

OTHER
Other: learning and recall of a sequence of body movements

Interventions

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 controlspersons with Multiple Sclerosis (MS)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • cognitive impairment hindering the understanding and execution of the experimental procedures,
  • pregnancy,
  • hearing impairment,
  • amusia
  • beat deafness,
  • colour blindness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Ghent

Ghent, 9000, Belgium

Location

National MS Center Melsbroek

Melsbroek, 1820, Belgium

Location

Revalidatie en MS Centrum Overpelt

Overpelt, 3900, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • peter Feys, prof. dr.

    Hasselt University

    PRINCIPAL INVESTIGATOR
  • lousin Moumdjian

    Hasselt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2019

First Posted

April 30, 2019

Study Start

December 18, 2018

Primary Completion

January 24, 2020

Study Completion

January 24, 2020

Last Updated

May 27, 2020

Record last verified: 2020-05

Locations