None listed
Conditions
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.
Interventions
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;
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.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed