UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Antonios Dominos
Organization	Plymouth University
Division name	School of Health Professions
Address	Papanastasiou 73, Aigaleo 12241, Greece
TEL	+30-6944440148
Email	hellodominos@gmail.com

Public contact
Name of contact person	Antonios Dominos
Organization	Plymouth University
Division name	School of Health Professions
Address	Papanastasiou 73, Aigaleo 12241, Greece
TEL	+30-6944440148
Homepage URL
Email	hellodominos@gmail.com

Sponsor
Institute	Plymouth University
Institute
Department

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

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 12 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023678