Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000215820
Ethics application status
Approved
Date submitted
6/02/2012
Date registered
20/02/2012
Date last updated
20/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Visually Induced Postural Sway in Elderly Fallers
Scientific title
Visually Induced Postural Sway in Elderly Fallers - Reduction of Dizziness
Secondary ID [1] 279742 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls in the elderly 285601 0
Condition category
Condition code
Musculoskeletal 285795 285795 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will undergo the Fallscreen from the Physiological Profile Assessment (PPA) (Lord, Menz, & Tiedemann, 2003) to assess their risk of falling.

FallScreen is a falls risk calculator and is designed as a comprehensive instrument suitable for Rehabilitation and Physical Therapy and Occupational Therapy settings and for dedicated Falls Clinics. It takes 45 minutes to administer and contains 15 items: three assessments of vision (high and low contrast visual acuity and edge contrast sensitivity), three assessments of peripheral sensation (tactile sensitivity, vibration sense and proprioception), assessments of three lower limb muscle groups (knee extensors, knee flexors and ankle dorsiflexors), assessments of both hand and foot reaction time and four assessments of body sway (sway on floor and foam with eyes open and closed).

The Roll Vection Test (RVT) (Lord and Webster 1990) will be used to assess visual dependence under a visually challenging situation. The system consists of an opened umbrella, 125cm in diameter, with 8 alternating black and white panels. The umbrella is mounted horizontally onto a height adjustable stand. During the test the umbrella is rotated at 16rpm. Attached is a smaller flat white disc (21cm diameter) uncoupled from the rotation of the umbrella. The disc extends out from the inner surface of the umbrella to about level with its rim. The white disc is marked with a straight black line across its centre. The subject will stand within arms reach of the disc, with the height of the axis of rotation of the umbrella and disc adjusted to eye level. At the start of the test the white disc is positioned so that the black line is offset by 26 degrees from vertical. After 30 seconds of rotation the subject will be asked to align the small disc so that the black line is vertical. The offset from vertical will be measured with a digital spirit level. Any offset over 4 degrees is defined as abnormal, and 6.5 degrees is defined as high risk of visual dependence.


Once this has been completed, each participant will be asked to stand on force plates in front of an ImmersaDome. The immersadome is a 2 meter wide freestanding dome that gives the feeling of being in a three-dimensional virtual environment (Immersadome information sheet attached).


The Immersadome will be positioned directly in front of the subject, up on blocks to ensure that it covers more than 130 degrees of the subjects’ visual angle (Dichgans et al., 1972). The experiment will begin with the subject standing on a force plate while measurements are taken under 6 conditions,

- feet apart (10 cm apart) eyes open,

- feet apart (10 cm apart) eyes closed,

- feet apart (10cm apart) and 4 different optokinetic visual stimuli (2 moving designs in opposing directions) projected onto the immersadome. Stimulus 1 is a roll vection clockwise and anticlockwise, and Stimulus 2 is a ‘moving through Hallway’ forwards or backwards.

During all balance tests a physiotherapist will be positioned next to the participant for safety purposes.

Postural sway will be measured using centre of pressure pathway. We will be comparing the size of postural sway between dizzy and non dizzy subjects. We will also compare subjects with higher and lower scores of visual dependance.


The full testing session, including the fallscreen, will take approximately 90 minutes to administer, and only occurs once.
Intervention code [1] 284051 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286461 0
Dizziness
- Self reported and Dizzy Handicap Inventory

Dizziness Handicap Inventory (DHI) (Jacobson and Newman 1990) was completed by those subjects with self reported dizziness. The DHI is a reliable and valid measure of self perceived handicap resulting from dizziness and has been shown to correlate with balance dysfunction (Jacobson and Newman 1990; Jacobson, Newman et al. 1991). Is consist of Total, Functional, Physical and Emotional catagories.
Timepoint [1] 286461 0
Baseline assessment only
Primary outcome [2] 286462 0
Roll Vection test of Visual Field Dependence (VFD) which has been shown to discriminate between fallers and non-fallers (Lord and Webster 1990).
Timepoint [2] 286462 0
Baseline assessment only
Primary outcome [3] 286463 0
The Situational Characteristics Questionnaire consist of 2 parts, SitQ_I & SitQ_II. The SitQ_II measures space and motion discomfort in the non-psychiatric setting and therefore was our measure of interest (Jacob, Redfern et al. 2009). We classified Abnormal-SMD with SITQ_II scores above 2 (Whitney, Jacob et al. 2005)
Timepoint [3] 286463 0
Baseline assessment only
Secondary outcome [1] 295924 0
The Goldberg Anxiety and Depression Scale (GAD)(Goldberg, Bridges et al. 1987)
Timepoint [1] 295924 0
Baseline assessment only
Secondary outcome [2] 295925 0
The Falls Efficacy Scale International (FES-I) 16 part questionnaire (Kempen, Yardley et al. 2008).
Timepoint [2] 295925 0
Baseline assessment only

Eligibility
Key inclusion criteria
Participants will be included if they are:
- 65 years and over
- Experience dizziness
- Able to stand unsupported for 1 minute
- Able to understand instruction and give informed consent
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are
- aged under 65
- are unable to stand unsupported for 1 minute
- Inability to understand instruction and give informed consent

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284525 0
University
Name [1] 284525 0
Flinders University
Country [1] 284525 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Daw Park Foundation
Address
Repatriation General Hopsital
Daws Road,
DAW PARK SA 5041
Country
Australia
Secondary sponsor category [1] 283454 0
None
Name [1] 283454 0
Address [1] 283454 0
Country [1] 283454 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286539 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 286539 0
Ethics committee country [1] 286539 0
Australia
Date submitted for ethics approval [1] 286539 0
Approval date [1] 286539 0
18/05/2009
Ethics approval number [1] 286539 0
EC00188

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

Contacts
Principal investigator
Name 33640 0
Address 33640 0
Country 33640 0
Phone 33640 0
Fax 33640 0
Email 33640 0
Contact person for public queries
Name 16887 0
James McLoughlin
Address 16887 0
Department of Rehab, Aged and Extented Care
GPO Box 2100
Adelaide SA 5001
Country 16887 0
Australia
Phone 16887 0
+61 8 8275 1103
Fax 16887 0
+61 8275 1130
Email 16887 0
[email protected]
Contact person for scientific queries
Name 7815 0
James McLoughlin
Address 7815 0
Department of Rehab, Aged and Extented Care
GPO Box 2100
Adelaide SA 5001
Country 7815 0
Australia
Phone 7815 0
+61 8 8275 1103
Fax 7815 0
+61 8275 1130
Email 7815 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.