Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001099011
Ethics application status
Approved
Date submitted
13/12/2010
Date registered
15/12/2010
Date last updated
29/04/2022
Date data sharing statement initially provided
29/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Postural sway of the community dwelling population aged 60 to 80
Scientific title
Postural sway of the Singapore community dwelling population aged 60 to 80: Normative data with a novel portable device.
Secondary ID [1] 253289 0
SRG#04/2010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postural sway 258815 0
Gait speed 258816 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258963 258963 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Normal standing postural sway is recorded on the laptop software linked to the Nintendo Wiiboard via bluetooth. Gait speed is calculated from 4m walk test time. Melbourne edge test for visual contrast sensitivity. Falls efficacy scale questionnaires for fear of fall quantification. All the tests will be conducted in 1 session post doctor consultation or during public screening. The session duration is 20 minutes
Intervention code [1] 257741 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259819 0
Postural sway with the Nintendo Wiiboard and a laptop software to analyse the peak velocity, anterior-posterior sway and mediolateral sway.
Timepoint [1] 259819 0
First visit
Secondary outcome [1] 268625 0
Gait speed is calculated from the time of a 4m walk with an additional 2m deceleration distance.
Timepoint [1] 268625 0
First visit

Eligibility
Key inclusion criteria
Fall less than 2 times in past 12 months;
Community dwelling;
Ambulatory independent;
Able to follow 3 steps instructions;
If in present of medical condition, it must be well-managed.
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Permanent bed-bound;
Significant cognitive disorder;
Untreated medical condition;
End-stage illness or disease;
Life expectancy less than 6 months;
Cerebral haemorrhage within the past 3 months;
Fractures in healing phase;
Surgery within the past 6 months;
Pulmonary embolism or deep vein thrombosis within 3 months;
Uncontrolled medical condition(s).

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/02/2011
Actual
20/12/2010
Date of last participant enrolment
Anticipated
29/04/2011
Actual
30/06/2011
Date of last data collection
Anticipated
Actual
30/06/2011
Sample size
Target
200
Accrual to date
Final
73
Recruitment outside Australia
Country [1] 3086 0
Singapore
State/province [1] 3086 0

Funding & Sponsors
Funding source category [1] 258206 0
Hospital
Name [1] 258206 0
Singapore General Hospital
Country [1] 258206 0
Singapore
Primary sponsor type
Hospital
Name
Singapore General Hospital
Address
1 Hospital Drive
Block 3 Level 1
Rehabilitation centre / Physiotherapy
Singapore 169608
Country
Singapore
Secondary sponsor category [1] 257378 0
None
Name [1] 257378 0
None
Address [1] 257378 0
None
Country [1] 257378 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260189 0
SingHealth Centralised Institutional Review Board
Ethics committee address [1] 260189 0
Ethics committee country [1] 260189 0
Singapore
Date submitted for ethics approval [1] 260189 0
Approval date [1] 260189 0
03/12/2010
Ethics approval number [1] 260189 0
2010/639/D

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32012 0
Mr Kwok Boon Chong
Address 32012 0
Bukit Batok Polyclinic
50 Bukit Batok West Avenue 3, Singapore 659164
Country 32012 0
Singapore
Phone 32012 0
+65 68962289
Fax 32012 0
Email 32012 0
[email protected]
Contact person for public queries
Name 15259 0
Kwok Boon Chong
Address 15259 0
Rehabilitation centre / Physiotherapy
Block 3 Level 1 Outram Road Singapore 169608
Country 15259 0
Singapore
Phone 15259 0
+65 9 7828332
Fax 15259 0
Email 15259 0
[email protected]
Contact person for scientific queries
Name 6187 0
Kwok Boon Chong
Address 6187 0
Rehabilitation centre / Physiotherapy
Block 3 Level 1 Outram Road Singapore 169608
Country 6187 0
Singapore
Phone 6187 0
+65 9 7828332
Fax 6187 0
Email 6187 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNovel use of the Wii Balance Board to prospectively predict falls in community-dwelling older adults.2015https://dx.doi.org/10.1016/j.clinbiomech.2015.03.006
N.B. These documents automatically identified may not have been verified by the study sponsor.