Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000132640
Ethics application status
Approved
Date submitted
23/01/2014
Date registered
5/02/2014
Date last updated
7/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Is a low cost electronic measure of balance as valid as a force platform in distinguishing the balance performance of a healthy and a clinical older population?
Scientific title
Does a low cost electronic measure of balance classify balance performance as intact or impaired as accurately as a force platform in healthy and clinical older populations?
Secondary ID [1] 283959 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 290987 0
Falls 290988 0
Condition category
Condition code
Stroke 291330 291330 0 0
Ischaemic
Physical Medicine / Rehabilitation 291331 291331 0 0
Physiotherapy
Stroke 291394 291394 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study seeks to determine concurrent validity of the CSMi HUMAC (Registered Trademark) Balance device against a ‘gold standard’ force platform measurement (Neurocom EquiTest (Registered Trademark) System).
The 2 different devices will be used to assess balance in 2 populations: 1. a healthy group of community dwelling individuals aged >60 years (N=20); 2. a group of community dwelling individuals aged >60 who have had a stroke (subacute or chronic, ie > 6 weeks post stroke)(N=20).
In a randomized order, subjects will undergo an assessment on each device over the course of about 1 hour. Assessment on the HUMAC device will include a modified Clinical Test of Sensory Interaction on Balance (mCTSIB) and a Limits of Stability (LOS) test. On the NeuroCom device a modified Sensory Organization Test (mSOT) and a LOS test will be performed. The mCTSIB and mSOT each have 4 conditions inwhich a subject stands still and has their balance assessed. The conditions include standing eyes open on a stable surface, standing eyes close on a stable surface, standing eyes open on a compliant surface, and standing eyes closed on a compliant surface. LOS testing requires subjects to stand still and then shift there weight as far as possible in 8 directions (N,NW,W,SW,S etc).
Subjects will be given 3 minute rests between each test condition on either device as well as 5 minute rest when changing between devices.
Intervention code [1] 288646 0
Rehabilitation
Intervention code [2] 288647 0
Prevention
Intervention code [3] 288699 0
Diagnosis / Prognosis
Comparator / control treatment
The ability of CSMi Humac (Registered Trademark) Balance device to accurately detect balance impairments will be assessed by comparing the outputs it give to those produced by the Neurocom EquiTest (Registered Trademark) System, which is considered to be the gold standard for assessing balance impairments.
Control group
Active

Outcomes
Primary outcome [1] 291321 0
Balance: Modified Clinical Test of Sensory Interaction on Balance (CSMi Humac)
Timepoint [1] 291321 0
At assessment
Primary outcome [2] 291322 0
Balance: Limits of Stability (CSMi Humac)
Timepoint [2] 291322 0
At assessment
Primary outcome [3] 291323 0
Balance: Sensory Organization Test (NeuroCom Equitest Balance Manager)
Timepoint [3] 291323 0
At assessment
Secondary outcome [1] 306527 0
Balance: Limits of Stability(NeuroCom Equitest Balance Manager)
Timepoint [1] 306527 0
At assessment

Eligibility
Key inclusion criteria
Healthy Population: >60 years, equal number of males and females, Community dwelling, can stand unsupported (no aids) for >1 min, walk >2 times/week, No falls history over prior 12 months

Stroke Population: >60 years, equal number of males and females, sub-acute or chronic stroke (>6/52 previously), community dwelling, Able to stand unsupported for >1 min unaided.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Healthy Population: Neurological or Musculoskeletal condition affecting balance

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)
Potential study candidates who meet inclusion/exclusion criteria will be invited to join the study. Participants will be given practice trials of all balance tasks on both devices to familiarize themselves with the testing procedures, devices and tasks.
After the practice trial, and a five-minute rest, participants will undergo balance assessments on each device in a randomized order. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Assuming 95% sensitivity, 95% specificity, an expected prevalence of stroke at 0.5 and setting a desired precision of 0.01, 39 participants is the minimum sample size required to establish a significant difference of the machines’ effectiveness in discriminating balance performance between healthy older people and older people with stroke.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/03/2014
Actual
23/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 288593 0
University
Name [1] 288593 0
Curtin University of Technology
School of Physiotherapy and Exercise Science
Country [1] 288593 0
Australia
Primary sponsor type
University
Name
Curtin University of Technology
Address
School of Physiotherapy and Exercise Science
Kent St,
Bentley, Perth WA 6102
Country
Australia
Secondary sponsor category [1] 287300 0
Hospital
Name [1] 287300 0
Sir Charles Gairdner Hospital
Physiotherapy Department
Address [1] 287300 0
QEII Medical Centre,
A Block, Ground Floor
Hospital Ave
Nedlands 6009
WA,
Country [1] 287300 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290456 0
Sir Charles Gairdner Hospital Group Human Research Ethics Committee
Ethics committee address [1] 290456 0
Ethics committee country [1] 290456 0
Australia
Date submitted for ethics approval [1] 290456 0
27/12/2013
Approval date [1] 290456 0
15/04/2014
Ethics approval number [1] 290456 0
2013-216

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

Contacts
Principal investigator
Name 45782 0
Prof Keith Hill
Address 45782 0
School of Physiotherapy and Exercise Science
Curtin University of Technology
Kent St,
Bentley, WA 6102
Country 45782 0
Australia
Phone 45782 0
+61 8 9266 4644
Fax 45782 0
Email 45782 0
[email protected]
Contact person for public queries
Name 45783 0
Evelyn Li Wen Chan
Address 45783 0
School of Physiotherapy and Exercise Science
Curtin University of Technology
Kent St,
Bentley, WA 6102
Country 45783 0
Australia
Phone 45783 0
+61 8 9266 4644
Fax 45783 0
Email 45783 0
[email protected]
Contact person for scientific queries
Name 45784 0
Evelyn Li Wen Chan
Address 45784 0
School of Physiotherapy and Exercise Science
Curtin University of Technology
Kent St,
Bentley, WA 6102
Country 45784 0
Australia
Phone 45784 0
+61 8 9266 4644
Fax 45784 0
Email 45784 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.