Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001024730
Ethics application status
Approved
Date submitted
12/09/2013
Date registered
13/09/2013
Date last updated
13/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Movement based computer gaming and standing balance.
Scientific title
The effect of movement based gaming on the control of centre of pressure in young and old adults.
Secondary ID [1] 283205 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance control 290065 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290447 290447 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Using a force platform, postural stability will be assessed. Following this, a 30 minute session of computer gaming using a hand held game controller will be administered while standing on the force platform. Movement of the Centre of Pressure (COP) will be recorded periodically during this time. At the conclusion of the gaming session, postural stability will be reassessed. We will compare both postural stability and the movement of COP during game play in young and old adults.
Intervention code [1] 287929 0
Treatment: Devices
Intervention code [2] 287930 0
Rehabilitation
Comparator / control treatment
None.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290470 0
Postural stability/Change in Centre of Pressure (COP) measured by force platform.
Timepoint [1] 290470 0
All Force Platform measurements of COP will be made before, during and after a 30 minute session of computer gaming in standing (same day).
Secondary outcome [1] 304567 0
none
Timepoint [1] 304567 0
NA

Eligibility
Key inclusion criteria
Healthy adults aged between 18 – 40 years or >70years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous history of neurological pathology.
Cognitive impairment.
Range of movement, strength, or balance deficits that prevent independent mobility and standing balance.
Visual or auditory limitations that prevent participants from seeing a normal computer screen (VDU) or hearing sound.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment of 20 volunteers from the local healthy population primarily by direct verbal request (10 in each required age range).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/09/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 5404 0
New Zealand
State/province [1] 5404 0
Canterbury

Funding & Sponsors
Funding source category [1] 287948 0
Government body
Name [1] 287948 0
Callaghan Innovation
Country [1] 287948 0
New Zealand
Primary sponsor type
Government body
Name
Callaghan Innovation
Address
c/- Dr Diana Siew
Callaghan Innovation
PO Box 2225
Shortland Street
Auckland 1140
Country
New Zealand
Secondary sponsor category [1] 286666 0
None
Name [1] 286666 0
Address [1] 286666 0
Country [1] 286666 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289875 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 289875 0
C/- MEDSAFE
PO Box 5013
Wellington 6145
Ethics committee country [1] 289875 0
New Zealand
Date submitted for ethics approval [1] 289875 0
09/08/2013
Approval date [1] 289875 0
29/08/2013
Ethics approval number [1] 289875 0
13/STH/103

Summary
Brief summary
This study will initially test a bilateral upper limb movement-based strategy using virtual reality for its effect on standing balance. This will be used as an indicator as to its potential to provide a sound rehabilitation modality with the potential to be used for falls prevention rehabilitation and balance retraining in older persons. Postural instability is strongly associated with falls in the elderly. The principal questions this study seeks to answer are 1) how does movement-based computer gaming using a handheld controller affect postural stability, and 2), whether a single bout of movement-based computer gaming using a handheld controller can acutely improve postural stability in an elderly population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42890 0
Dr Kimberlee Jordan
Address 42890 0
c/- Callaghan Innovation
PO Box 20028
Christchurch 8543
Country 42890 0
New Zealand
Phone 42890 0
+6433586824
Fax 42890 0
Email 42890 0
[email protected]
Contact person for public queries
Name 42891 0
Dr Kimberlee Jordan
Address 42891 0
c/- Callaghan Innovation
PO Box 20028
Christchurch 8543
Country 42891 0
New Zealand
Phone 42891 0
+6433586824
Fax 42891 0
Email 42891 0
[email protected]
Contact person for scientific queries
Name 42892 0
Dr Kimberlee Jordan
Address 42892 0
c/- Callaghan Innovation
PO Box 20028
Christchurch 8543
Country 42892 0
New Zealand
Phone 42892 0
+6433586824
Fax 42892 0
Email 42892 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.