Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000424505
Ethics application status
Approved
Date submitted
17/04/2015
Date registered
5/05/2015
Date last updated
22/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Dynamic Balance measures using a Kinect Camera; a validation study
Scientific title
Comparing functional reach and sit to stand test using traditional and technological data collection methods in healthy adults
Secondary ID [1] 286547 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dynamic postural balance control 294792 0
Condition category
Condition code
Neurological 295068 295068 0 0
Studies of the normal brain and nervous system
Musculoskeletal 295125 295125 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be requested to perform the functional reach test 3 times with each arm (arm parallel to the floor) in front of a Kinect camera in standing. A wash out period of 5 minutes between trials will be used to ensure no fatigue.

Participants will then be requested to stand from a sitting position as many times as they can in 30 seconds, with the number of repetitions counted by the camera software.
Intervention code [1] 291652 0
Early detection / Screening
Comparator / control treatment
Participants will be requested to perform the functional reach test 3 times with each (arm parallel to the floor) while standing next to a tape measure in standing.

Participants will then be requested to stand from a sitting position as many times as they can in 30 seconds, with the number of repetitions counted by the researcher with a stop watch..
Control group
Active

Outcomes
Primary outcome [1] 294832 0
Range of motion excursion of the hand will be measured (in centremetres)
Timepoint [1] 294832 0
Baseline
Secondary outcome [1] 314176 0
Reliability of the new technology will aslo be measured using ICC and 95% confidence intervals in STATA program
Timepoint [1] 314176 0
Baseline
Secondary outcome [2] 314359 0
Functional balance as measured by sit-to-stand in 30 seconds
Timepoint [2] 314359 0
Baseline

Eligibility
Key inclusion criteria
Healthy adults recruited from university staff and student population
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to stand unaided for 5 minutes.
Less than 90 degrees motion at each shoulder joint
Lower limb amputation
Current or past neurological condition

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will draw a coloured chip from a hat (eyes closed) and select either a blue or red chip. Participants who draw a red chip will complete the traditional measure with a tape measure data collection method first; participants who draw a blue chip will complete the kinect camera based data collection first
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis
Bland altman plots will be generated from the mean data to determine limits of agreement for the two methods of data collection (manual and electronic). As well, co-efficient of variation will be generated for the novel data collection tool - the Kinect camera. Sample size is based on previous research examining normative data for functional reach (13.8±2.2 inches) with a clinically relevant difference of 10% (1.3 inches) and a reported a power of 80% indicates a sample of 23 people is required.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/05/2015
Actual
28/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
23
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 291113 0
University
Name [1] 291113 0
The Faculty of Health
University of Tasmania
Country [1] 291113 0
Australia
Primary sponsor type
University
Name
The University of Tasmania
Address
Locked Bag1322
Launceston
TAS 7250
Country
Australia
Secondary sponsor category [1] 289789 0
None
Name [1] 289789 0
Address [1] 289789 0
Country [1] 289789 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292694 0
Tasmanian Health and Medical Research Ethics committee
Ethics committee address [1] 292694 0
Ethics committee country [1] 292694 0
Australia
Date submitted for ethics approval [1] 292694 0
Approval date [1] 292694 0
16/04/2015
Ethics approval number [1] 292694 0
H0014764

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

Contacts
Principal investigator
Name 55070 0
Dr Marie-Louise Bird
Address 55070 0
The School of Health Science
The University of Tasmania
Locked Bag 1322
Launceston TAS 7250
Country 55070 0
Australia
Phone 55070 0
+61 3 63425497
Fax 55070 0
Email 55070 0
birdm@utas.edu.au
Contact person for public queries
Name 55071 0
Marie-Louise Bird
Address 55071 0
The School of Health Science
The University of Tasmania
Locked Bag 1322
Launceston TAS 7250
Country 55071 0
Australia
Phone 55071 0
+61 3 63425497
Fax 55071 0
Email 55071 0
birdm@utas.edu.au
Contact person for scientific queries
Name 55072 0
Marie-Louise Bird
Address 55072 0
The School of Health Science
The University of Tasmania
Locked Bag 1322
Launceston TAS 7250
Country 55072 0
Australia
Phone 55072 0
+61 3 63425497
Fax 55072 0
Email 55072 0
birdm@utas.edu.au

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.