Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000732189
Ethics application status
Approved
Date submitted
8/05/2019
Date registered
16/05/2019
Date last updated
4/06/2019
Date data sharing statement initially provided
16/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of individualised, vibrotactile neurofeedback training on postural stability in older adults with hearing impairment: a randomised double-blind, placebo-controlled multi centre trial.
Scientific title
The effect of individualised, vibrotactile neurofeedback training on postural stability in older adults with hearing impairment: a randomised double-blind, placebo-controlled multi centre trial.
Secondary ID [1] 293997 0
Nil
Universal Trial Number (UTN)
Trial acronym
The VIBRANT Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing impairment 306650 0
Condition category
Condition code
Ear 305752 305752 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will complete vibrotactile feedback training when performing gait or standing balance tasks. They will wear a waist-worn device (Vertiguard, Zeisberg GmbH) that provides directional vibratory stimulation in response to the amplitude and direction of postural sway. The Vertiguard device consists of (a) a battery-powered main unit (190g) housing gyroscopes to continuously detect and record the Coriolis force occurring during body movements in pitch and roll; and (b) four vibration stimulators mounted on front, back, left and right sides on the same waist-belt as the main unit to provide feedback. During testing, participants complete a series of 14 standing balance and gait tasks while wearing the device. Examples of tasks include standing for 20 seconds on a firm or foam surface with eyes open or closed, on one leg or two; standing up from sitting; or walking 3m at a normal speed with head turns. The six tasks that demonstrate the greatest sway in comparison to age- and sex-related normative data are identifed and automatically set by the device as the training tasks. Rehabilitation exercises will be performed daily over a 2-week period with 10 days of exercising (weekends excluded). Participants will complete one-on-one face-to-face training with a physiotherapist with a minimum of 10 years experience for the first 5 days, and on their own for the final 5 days. Participants will receive training from the treating physiotherapist on how to use the device for the home sessions. Each session will contain 5 repetitions of the selected tasks, which are similar to the tasks tested. e.g. holding a one-leg standing position as still as possible for 20 seconds. The Vertiguard device provides vibrotactile feedback from the stimulator mounted on the waist in the direction of increased sway. For example, if the participant showed increased sway to the right in comparison to normative data, then the right stimulator would vibrate during the training. The device detects sway in realtime and adjusts the feedback required. Over time the person accommodates to the sensation of stimulation. A time limit for 1 repetition of a stance task will be set at 20 seconds and as long as needed for gait tasks. The total daily training time is estimated to be approximately 15 to 20 minutes. Adherence to training will be monitored via the data log of the training device. Attendance at face to face training sessions will be monitored.

The second intervention group are the sham group. Participants assigned to the sham (placebo) group will performed a similar protocol to the active group with the six tasks showing greatest deviation from normative data identified to be performed in training. During the rehabilitation phase, they will wear a sham device that will be programmed to prompt performance of the six tasks identified, but instead of providing targeted vibrotactile feedback, randomly assigned signals will be emitted from the vibrators. Adherence will be monitored in the same way as the intervention group.
Intervention code [1] 300357 0
Rehabilitation
Intervention code [2] 300569 0
Treatment: Devices
Comparator / control treatment
Participants assigned to the control group will performed a similar protocol to the other two groups. During the rehabilitation phase, they will wear a control device that will be programmed to prompt performance of the six tasks identified, and not provide any signals from the vibrators. The screen will indicate what tasks need to be performed, but no feedback will be provided. Adherence will be monitored in the same way as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 305091 0
Postural sway during gait and balance tasks will be measured using the composite score of the Geriatric Standard Balance Deficit Test (gSBDT)
Timepoint [1] 305091 0
Baseline (week 0), in the week following conclusion of the final intervention session (week 2)
Secondary outcome [1] 344134 0
Postural sway during gait and balance tasks will be measured using the composite score of the Geriatric Standard Balance Deficit Test (gSBDT)
Timepoint [1] 344134 0
Follow-up six months after intervention commencement
Secondary outcome [2] 370120 0
Self reported dizziness as measured using the mean score of the Dizziness Handicap Inventory
Timepoint [2] 370120 0
Baseline (week 0), in the week following conclusion of the final intervention session (week 2), and follow-up six months after intervention commencement.
Secondary outcome [3] 370121 0
Self-reported physical activity as measured using the mean score of the Physical Activity Scale for the Elderly (PASE)
Timepoint [3] 370121 0
Baseline (week 0), in the week following conclusion of the final intervention session (week 2), and follow-up six months after intervention commencement.
Secondary outcome [4] 370122 0
Self-reported balance confidence as measured using the mean score of the Activity-Specific Balance Confidence (ABC) Scale
Timepoint [4] 370122 0
Baseline (week 0), in the week following conclusion of the final intervention session (week 2), and follow-up six months after intervention commencement.
Secondary outcome [5] 370123 0
Gait speed under dual task conditions measured using the dual task Timed Up and Go (TUG) test
Timepoint [5] 370123 0
Baseline (week 0), in the week following conclusion of the final intervention session (week 2), and follow-up six months after intervention commencement.
Secondary outcome [6] 370257 0
Gait speed under single task conditions will be assessed using the 10m walk test
Timepoint [6] 370257 0
Baseline (week 0), in the week following conclusion of the final intervention session (week 2), and follow-up six months after intervention commencement.

Eligibility
Key inclusion criteria
Aged 60 years or older
Bilateral four frequency average hearing loss (4FAHL) at 500, 1000, 2000 and 4000 Hz to be between 40 and 90 dB HL, with 4FAHL difference between ears to be no greater than 15 dB HL.
Self-reported dizziness, vertigo or unsteadiness for at least 12mths
A score >20 on Dizziness Handicap Inventory score (DHI)
A composite score of >39 -Geriatric Standard Balance Deficit (gSBDT) test
Residing in the community or low care dwelling
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe vision impairment when using glasses (Scoring 0.2 or lower on Landolt-rings test table.
Benign paroxysmal positional vertigo (BPPV) either at the time of screening as determined by a positive Dix-Hallpike maneuver or diagnosis of BPPV within the last 2weeks prior to screening.
History of Meniere’s disease or acoustic neuroma
Medical conditions affecting balance, limiting ability to walk without assistance (e.g. stroke, Parkinson’s disease), or to safely exercise
Cognitive impairment as reflected by a score of <23/30 on the MoCA
Being unable to perform half of the test exercises of the gSBDT (<7 / 14 exercises)
History of drug abuse or alcoholism with the last 2 years
Taking sedative medications (e.g. diazepam) on a daily basis, between the hours of 6am and 6pm.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following baseline assessment consecutively numbered, randomly ordered opaque envelopes containing group allocation will be opened by an independent researcher who will select the device that is programmed for this group (active, sham or control). The treating therapist will then apply this device. There is no indication on the device as to the type of stimulation provided.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed offsite by a person independent to the study. Computerised random numbers will be generated in variable block permutations of 4 or 6.
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample of 207 participants in total will be recruited across three sites to show an effect size of 0.4 in change of the Geriatric Standard Balance Deficit Test score from pre-post at the post intervention (2 weeks) time point, alpha of 0.05 and power of 80%. Each site will aim to recruit 69 participants. This calculation was based on previous studies of older adults using the Vertiguard device with the same protocol to improve the Geriatric Standard Balance Deficit Test score (Basta et al, 2017) that resulted in a sample size of 69 people /group, which includes an allowance for dropouts of 15% resulting in a planned sample size of 207 people in total.

An intention to treat approach will be used in analysis. To determine if there is an impact of intervention on outcome measures, linear mixed models will be used for analysis of outcome measures, investigating the impact of group, time and group x time interactions. Data will be screened to ensure assumptions are met (e.g. Kolmogoroff-Smirnoff-test for normal distribution). If data is not normally distributed, appropriate approaches will be used (e.g. transformations) or non-parametric tests will be performed if it is not possible to obtain a normal distribution. Pairwise comparisons will be performed if interactions are significant. Statistics will be performed using SPSS v22.0. The significance levels will be 0.05 (a) and 0.2 (ß). Alpha will be adjusted to 0.0253 due to the multiple comparisons.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2019
Actual
Date of last participant enrolment
Anticipated
1/01/2021
Actual
Date of last data collection
Anticipated
1/06/2021
Actual
Sample size
Target
207
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 26407 0
4072 - University Of Queensland
Recruitment outside Australia
Country [1] 21457 0
Germany
State/province [1] 21457 0
Brandenberg
Country [2] 21458 0
United States of America
State/province [2] 21458 0
New York

Funding & Sponsors
Funding source category [1] 298625 0
Commercial sector/Industry
Name [1] 298625 0
Sonova AG
Country [1] 298625 0
Switzerland
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia, Qld 4072
Country
Australia
Secondary sponsor category [1] 297790 0
None
Name [1] 297790 0
Address [1] 297790 0
Country [1] 297790 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299585 0
University of Queensland Human Research Ethics Committee
Ethics committee address [1] 299585 0
Office of Research Ethics
The University of Queensland
Brisbane Qld 4072 Australia
Ethics committee country [1] 299585 0
Australia
Date submitted for ethics approval [1] 299585 0
30/01/2019
Approval date [1] 299585 0
03/06/2019
Ethics approval number [1] 299585 0
2019000194

Summary
Brief summary
The aim of this project is to assess the effectiveness of a 10 day intervention of individualised vibrotactile neurofeedback training (iVNT) on balance performance and postural stability in an elderly population with moderate to severe hearing loss and self-reported dizziness. Two-hundred and seven participants will be recruited across Brisbane, Berlin and New York (69 per site) and they will be randomised to one of the three groups: intervention, placebo and control. The first 3 to 5 days of training will occur at the campus location and the following sessions will occur in-home with support provided as needed. The intervention involves the participant wearing a device that delivers vibrotactile neurofeedback during set training tasks. The primary outcome measure will be to determine the effect of training on balance immediately after the two-week intervention period. Secondary outcome measures are to determine the effect of training on balance at six months after the start of training; and on dizziness, gait speed under single and dual task conditions, balance confidence, and physical activity at 2 weeks and six months after the start of training.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80926 0
Prof Sandra Brauer
Address 80926 0
School of Health and Rehabilitation Sciences,
The University of Queensland
St Lucia, Qld, 4072
Country 80926 0
Australia
Phone 80926 0
+61 7 3365 2317
Fax 80926 0
Email 80926 0
[email protected]
Contact person for public queries
Name 80927 0
Ms Katrina Kemp
Address 80927 0
School of Health and Rehabilitation Sciences,
The University of Queensland
St Lucia, Qld, 4072
Country 80927 0
Australia
Phone 80927 0
+61 7 3365 2779
Fax 80927 0
Email 80927 0
[email protected]
Contact person for scientific queries
Name 80928 0
Dr Barbra Timmer
Address 80928 0
School of Health and Rehabilitation Sciences,
The University of Queensland
St Lucia, Qld, 4072
Country 80928 0
Australia
Phone 80928 0
+61 7 3365 2016
Fax 80928 0
Email 80928 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results after de-identifying
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator


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.