UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020541
Receipt number R000023678
Scientific Title The effects of music on dynamic balance exercise among healthy 18-35 year olds as measured by the Four Square Step Test (FSST): A randomized double-blinded controlled study
Date of disclosure of the study information 2016/01/13
Last modified on 2017/03/07 09:15:19

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Basic information

Public title

The effects of music on dynamic balance exercise among healthy 18-35 year olds as measured by the Four Square Step Test (FSST):
A randomized double-blinded controlled study

Acronym

The effects of music on dynamic balance exercise:
A randomized double-blinded controlled study

Scientific Title

The effects of music on dynamic balance exercise among healthy 18-35 year olds as measured by the Four Square Step Test (FSST):
A randomized double-blinded controlled study

Scientific Title:Acronym

The effects of music on dynamic balance exercise:
A randomized double-blinded controlled study

Region

Europe


Condition

Condition

Dynamic balance

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Hypothesis 1: music (both motivational and non-motivational) will have a negative effect on balance performance compared to no music.

Basic objectives2

Others

Basic objectives -Others

Hypothesis 2: motivational music will have a greater negative effect on balance performance compared to non-motivational music.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

The time taken to perform the Four Square Step Test with music and without.
(times taken at baseline and 7 days post commencement of intervention)

Key secondary outcomes

The time taken to perform the Four Square Step Test with motivational music and with non-motivational music.
(times taken at baseline and 7 days post commencement of intervention)


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Participants will be timed while performing the Four Square Step Test without music. The test will be precluded by instructions and one practice trial. Two timed trials will then be performed, of which the fastest time will be recorded.
The time to administer the test is <5 minutes
http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=900

Interventions/Control_2

Participants will be timed while performing the Four Square Step Test with motivational music (BMRI-2 scale). Playback volume will be fixed at 70 db. The test will be precluded by instructions and one practice trial. Two timed trials will then be performed, of which the fastest time will be recorded.
The time to administer the test is <5 minutes
http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=900

Interventions/Control_3

Participants will be timed while performing the Four Square Step Test with non-motivational music (BMRI-2 scale). Playback volume will be fixed at 70 db. The test will be precluded by instructions and one practice trial. Two timed trials will then be performed, of which the fastest time will be recorded.
The time to administer the test is <5 minutes
http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=900

Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

35 years-old >=

Gender

Male and Female

Key inclusion criteria

Males and females between the ages of 18-35

Key exclusion criteria

Any Hearing or visual impairments
Any Musculoskeletal or neurological disorders

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Antonios Dominos

Organization

Plymouth University

Division name

School of Health Professions

Zip code


Address

Papanastasiou 73, Aigaleo 12241, Greece

TEL

+30-6944440148

Email

hellodominos@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Antonios Dominos

Organization

Plymouth University

Division name

School of Health Professions

Zip code


Address

Papanastasiou 73, Aigaleo 12241, Greece

TEL

+30-6944440148

Homepage URL


Email

hellodominos@gmail.com


Sponsor or person

Institute

Plymouth University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Attico College
Stournari 26
Athens, 10433
Greece
tel: +30-2108836002

Name of secondary funder(s)

Angeliki Tanti


IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 13 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2015 Year 12 Month 16 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 25 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 01 Month 13 Day

Last modified on

2017 Year 03 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023678


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name