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
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
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
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
