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Trial registered on ANZCTR
Registration number
ACTRN12620001172998
Ethics application status
Approved
Date submitted
6/08/2020
Date registered
9/11/2020
Date last updated
9/11/2020
Date data sharing statement initially provided
9/11/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of exercise and brain stimulation on balance and walking in people at risk of falling: A feasibility study
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Scientific title
Noisy galvanic vestibular stimulation (nGVS) combined with balance rehabilitation in older adults with moderate to high falls risk: A feasibility study for an RCT
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Secondary ID [1]
301438
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none
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Universal Trial Number (UTN)
U1111-1241-2231
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Balance impairment
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Falls
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Gait disorder
317755
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Condition category
Condition code
Physical Medicine / Rehabilitation
315810
315810
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0
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Physiotherapy
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Injuries and Accidents
317353
317353
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention:
Participants will attend a rehabilitation exercise programme delivered in groups of 4-6 older adults by a physiotherapist twice a week for 8 weeks. An attendance record will be kept by the Physiotherapist running the programme.
The exercise programme is a 50 minute, low intensity progressive programme based on standard principles of balance training focussing on the integration of the visual, vestibular and somatosensory systems. Types of exercises in the programme include; standing and walking on unstable surfaces, vestibular ocular habituation (head turning) exercises, and controlling limits of stability (standing with a progressively smaller base of support)- these will all be done at a Borg scale of exertion 11-12 (Exercises that require some exertion but not enough to speed up your breathing). The exercise session will conclude with 5-minutes static cycling at a Borg scale of perceived exertion of around 13 (Requiring moderate effort and speeds up your breathing but doesn’t make you out of breath).
Treatment group participants will complete the exercise programme whilst receiving noisy Galvanic Stimulation (nGVS) for 45 minutes. Participants wear electrodes placed over the mastoid process by either the Physiotherapist or research assistant and attached to a commercially available galvanic stimulator (Softrex Medical). Staff will be trained in the application and use of the nGVS machines by a member of the research team experienced in their use. The nGVS machines are designed for research and will be programmed to the nGVS setting by an unblinded member of the research team and numbered with the participants study number. The nGVS is white noise GVS - a zero-mean random signal with equal intensities at different frequencies. The intensity is set at 0.5mA and is of imperceptable magnitude (the participant is unable to feel or hear the nGVS).
Comparator/ Control group
This study uses a 3-armed randomised double blinded, parallel, control trial design. There will be two groups that control for treatment effect, the sham group and the control group.
The Sham Group will wear electrodes over the mastoid process applied by the Physiotherapist or Research assistant and attached to the galvanic stimulator which has been programmed to the sham setting by the unblinded researcher. As the nGVS is administered at a subsensory level neither the Therapist or participant will know whether they are receiving sham nGVS or nGVS. Sham group participants will partake in the same exercise programme as the treatment group participants. The Control Group will receive no intervention (nGVS or exercise programme) but will be offered the same balance rehabilitation programme as the treatment and sham group after the 6-month follow up assessment.
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Intervention code [1]
317749
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Rehabilitation
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Comparator / control treatment
This study uses a 3-armed randomised double blinded, parallel, control trial design. There will be two groups that control for treatment effect, the sham group and the control group.
The Sham Group will wear electrodes over the mastoid process applied by the Physiotherapist or Research assistant and attached to the galvanic stimulator which has been programmed to the sham setting by the researcher. As the nGVS is administered at a subsensory level neither the Therapist or participant will know whether they are receiving sham nGVS or nGVS. Sham group participants will partake in the same exercise programme as the treatment group participants. The Control Group will receive no intervention (nGVS or exercise programme) but will be offered the same balance rehabilitation programme as the treatment and sham group after the 6 month follow up assessment.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Balance: Measured by Centre of Pressure (COP) excursion of a force plate.
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Assessment method [1]
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Timepoint [1]
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Week 1, week 10, week 22 and week 36 post participant enrolment
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Primary outcome [2]
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Gait: Gait parameters measured during Single and dual task gait.
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Assessment method [2]
324016
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Timepoint [2]
324016
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Week 1, week 10, week 22 and week 36 post participant enrolment
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Primary outcome [3]
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Spatial memory: Triangle Completion task
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Assessment method [3]
324017
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Timepoint [3]
324017
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Week 1, week 10, week 22 and week 36 post participant enrolment
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Secondary outcome [1]
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Lower limb strength: 30 second chair stand
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Assessment method [1]
383549
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Timepoint [1]
383549
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Week 1, week 10, week 22 and week 36 post participant enrolment
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Secondary outcome [2]
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Acceptability of the treatment: Semi structured interview
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Assessment method [2]
383553
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Timepoint [2]
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Week 10 post participant enrolment
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Secondary outcome [3]
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4 Stage Balance test
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Assessment method [3]
386533
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Timepoint [3]
386533
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Week 1, week 10, week 22 and week 36 post participant enrolment
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Secondary outcome [4]
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Timed up and go
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Assessment method [4]
386534
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Timepoint [4]
386534
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Week 1, week 10, week 22 and week 36 post participant enrolment
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Secondary outcome [5]
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Functional Gait Assessment
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Assessment method [5]
386535
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Timepoint [5]
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Week 1, week 10, week 22 and week 36 post participant enrolment
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Secondary outcome [6]
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Activities- specific balance confidence scale
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Assessment method [6]
386536
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Timepoint [6]
386536
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Week 1, week 10, week 22 and week 36 post participant enrolment
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Secondary outcome [7]
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4 Mountains Test
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Assessment method [7]
386537
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Timepoint [7]
386537
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Week 1, week 10, week 22 and week 36 post participant enrolment
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Secondary outcome [8]
387760
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Feasibility: Recruitment capacity and the resulting sample characteristics:
Number of eligible participants
Drop out rate over intervention and follow up period
Recruitment rate (goal of 2 participants per week for the duration of the study)
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Assessment method [8]
387760
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Timepoint [8]
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Week 1, Week 10, Week 22, Week 36
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Secondary outcome [9]
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Feasibility: Data collection procedures and outcome measures
Are the data collection procedures and outcome measures appropriate for the intended population and study aims? For the measure of postural sway which parameter is most sensitive to change and should be selected for the full study? The feasibility of using 3D motion analysis and the value of the data collected from the 3D motion analysis will be investigated. If kinematic variables measuring head movement appear to provide important additional information we will collect in the Full Study.
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Assessment method [9]
387761
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Timepoint [9]
387761
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Week 1, Week 10, Week 22, Week 36
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Secondary outcome [10]
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Feasibility: The acceptability and suitability of the intervention and study procedures.
Are the study procedures and interventions suitable and acceptable to participants and physiotherapists? What if any modifications to study procedures and/or intervention are required?
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Assessment method [10]
387762
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Timepoint [10]
387762
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Week 1, Week 10, week 22, week 36, Therapist Qualitative interviews.
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Secondary outcome [11]
387763
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Feasibility: A preliminary evaluation of participant responses to the intervention.
Does the intervention show promise at being successful with the intended population? What effect size is found in the Feasibility Study?
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Assessment method [11]
387763
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Timepoint [11]
387763
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Week 1, week 10, week 22, week 36
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Eligibility
Key inclusion criteria
Community-dwelling adults aged 65 and above or Maori/ Pasifika aged 55 and above at risk of falling according to the STEADI screening tool
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Minimum age
55
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Neurological condition diagnosed by a medical practitioner
A pacemaker or metal implants in the head or neck region
Vertigo
Unable to follow a three step instruction
Unable to stand independently for 5 minutes
Unable to ambulate with or without walking aids for 10 metres
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group allocation is concealed in a sealed opaque envelope
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated group allocation stratified by age, falls history in the past 6 months and number of medications the participant is taking.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
In this Feasibility Study there is no intention to formally investigate intervention effectiveness and analysis will focus on descriptive and correlational statistics. Examination of the data at the participant level will be done to determine if changes in key outcome variables occurred.Inspection of the data will inform the Full Study and help refine participant selection, test protocol, and choice of outcomes. Responsiveness metrics such as effect size and standardised response mean will be calculated for postural control outcomes to inform selection of primary outcome and power calculations for the intervention study.
Qualitative data
Patients and therapists will be interviewed at the end of the intervention period using a semistructured format. Interviews will be audio recorded and transcribed verbatim. Data will be analysed in NVivo using methods of constant comparison in which data is examined for similar themes. Initial qualitative findings will acted on during the feasibility study and further interviews undertaken to check if improvements had occurred.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/12/2020
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Actual
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Date of last participant enrolment
Anticipated
31/07/2022
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Actual
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Date of last data collection
Anticipated
31/12/2022
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Actual
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Sample size
Target
72
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
22655
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New Zealand
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State/province [1]
22655
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Auckland
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Funding & Sponsors
Funding source category [1]
305876
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Government body
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Name [1]
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Health Research Council of New Zealand
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Address [1]
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Level 3 - ProCARE Building,
Grafton Mews,
110 Stanley Street
Grafton,
Auckland 1010
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Country [1]
305876
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New Zealand
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Primary sponsor type
University
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Name
Auckland University of Technology
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Address
90 Akoranga Drive
Northcote
Auckland 0627
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
306332
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Address [1]
306332
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Country [1]
306332
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306136
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Southern Health and Disability Ethics Committee
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Ethics committee address [1]
306136
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Postal address: Ministry of Health Health and Disability Ethics Committees PO Box 5013 Wellington 6140 Street address: 133 Molesworth Street Thorndon Wellington 6011
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Ethics committee country [1]
306136
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New Zealand
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Date submitted for ethics approval [1]
306136
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24/06/2020
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Approval date [1]
306136
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22/09/2020
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Ethics approval number [1]
306136
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20/STH/111
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Summary
Brief summary
Intact postural control (balance) is essential for safe and effective movement. Age-related decline in postural control threatens everyday activity and reduced levels of mobility, and confidence and increased risk of falls and gait impairment. Evidence suggests that balance training improves mobility, confidence and spatial cognition and reduces falls. A recent advance is the use of sub-sensory threshold noisy galvanic vestibular stimulation (nGVS), which uses galvanic stimulation delivered with a gaussian noise signal to enhance weak sensory input and facilitate information processing in sensory systems. nGVS has been shown to improve postural control, cognition and gait parameters in older adults, people with vestibular disorders and people with Parkinson’s disease. This study assesses the effect of nGVS to alter balance and gait when delivered in conjunction with a group balance rehabilitation programme. Using nGVS to augment a balance programme is a novel use of this technology. If effective, this has the potential to enhance the effect of balance retraining reducing the profound and significant sequale of reduced mobility and falls to health. The Feasibility Study aim is to evaluate trial processes to determine if the design is feasible. A secondary aim is to evaluate the outcome measures to inform the design of a full RCT and also participant opinions of the intervention to refine the Full Study protocol. The aim of a subsequent Full Study is to determine if an 8 week balance rehabilitation programme augmented with noisy galvanic stimulation (nGVS) is effective in improving postural stability compared to either the balance programme with a sham nGVS or a no intervention control in older adults with moderate to high falls risk.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Denise Taylor
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Address
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Auckland University of Technology
90 Akoranga Drive.
Northcote.
Auckland 0627
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Country
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New Zealand
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Phone
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+64 09 9219999
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Fax
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Email
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denise.taylor@aut.ac.nz
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Contact person for public queries
Name
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Denise Taylor
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Address
102835
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Auckland University of Technology
90 Akoranga Drive.
Northcote.
Auckland 0627
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Country
102835
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New Zealand
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Phone
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+64 09 9219999
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Fax
102835
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Email
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denise.taylor@aut.ac.nz
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Contact person for scientific queries
Name
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Denise Taylor
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Address
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Auckland University of Technology
90 Akoranga Drive.
Northcote.
Auckland 0627
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Country
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New Zealand
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Phone
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+64 09 9219999
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Fax
102836
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Email
102836
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denise.taylor@aut.ac.nz
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
Download to PDF