Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
Phase: NA
Conditions: Vestibular Disorder, Dizziness
Sponsor: Barron Associates, Inc.

 
Head-Mounted Vibrotactile Prosthesis for Patients 
With Chronic Postural Instability 
NCT03330262 
 
Study Protocol 
Document Date: 01/25/2021 
 
 
 

OVERVIEW 
Background information: 
 
An initial pilot study (Goebel et.al., 2009) revealed that vibrotactile stimulation of 
the head with orientationally-correct information provided significant improvement 
in postural stability in vestibular loss patients as seen in decreased falls and 
increased Time To Fall measurements. It also revealed that there was no effect 
noted upon perceived verticality during eccentric rotation. Overall, it concluded that 
the utility of a head-mounted balance prosthesis had broader applications besides 
use in patients with severe vestibular loss and that such a device might also be 
useful for rehabilitation in a variety of patients with partial vestibular, visual or even 
somatosensory loss or cases with abnormal sensory integration (i.e. traumatic 
brain 
injury).  
 
Goebel JA, Sinks BC, Parker BE Jr, Richardson NT, Olowin AB, Cholewiak RW. 
Effectiveness of Head-Mounted Vibrotactile Stimulation in Subjects with Bilateral 
Vestibular Loss: A Phase 1 Clinical Trial. Otol Neurotol. 2009 Feb; 30 (2):210-6. PMID: 
19106768  
 
A recently completed Phase 1 SBIR effort revealed, based on the usability 
questionnaire results, that the balance cap (BALCAP) was well-received by the 
participants. Significance was demonstrated for several hypotheses, and overall 
trends indicated that in general, use of the BALCAP prosthesis resulted in better 
scores on standard balance assessments (i.e., assistive benefit); and that in 
general, the proposed BALCAP-based therapy resulted in improved assessment 
scores (i.e., rehabilitative benefit). Although refinements to the BALCAP device are 
warranted (e.g., a smaller electronics package, more control of stimulation 
amplitude, etc.), feasibility for the BALCAP concept has been shown.  
 
Rationale: 
 
Chronic imbalance leads to significant problems. This study is designed to evaluate 
a device (cap) which can potentially improve the balance of these patients.  
 
Research Objectives:  
 
The goal of this project is to provide individuals who have demonstrated chronic 
imbalance, independent of etiology, a tactile prosthesis that will help them maintain 
a correct sense of orientation with respect to the gravity and improve posture 
control.  
The proposed work will evaluate the assistive efficacy of such a balance prosthesis 
in a population of chronic imbalance patients spanning a wide range of disease 
etiologies.   
 
It will also investigate the rehabilitative potential of the BALCAP device based on 
a 6-week structured training regimen that includes both static and dynamic 

exercises. If rehabilitative training to achieve residual balance retention is possible, 
expanding training to include both static and dynamic activities is most likely to 
make it evident.   
 
Potential Contribution:  
 
This proposal addresses a National Institute on Deafness and Other 
communication Disorders (NIDCD) research topic that emphasizes the 
“development of assistive devices for balance disorders”. 
 
If the hypothesis concerning the assistive benefit is supported, a head-mounted 
vibrotactile prosthesis product would enable immediate benefit to be provided to a 
large number of patients with chronic postural instability. 
If rehabilitative training to achieve residual balance retention is possible, it would 
open new areas of research, such as how to optimize training to maximize residual 
retention of balance improvements. 
 
METHODS 
Timeline:  
 
Each subject will be enrolled for up to twelve weeks. There will be a sufficient 
number of devices manufactured to enable all subjects to be completed within one 
year from start of device availability. 
 
Inclusion/Exclusion criteria: 
 
Subjects will include patients between the ages of 21-89 years of age with chronic 
balance dysfunction spanning a range of etiologies (e.g., peripheral dysfunction, 
central dysfunction, and multi-factorial disequilibrium, also referred to as 
disequilibrium of aging).  
Inclusion Criteria:  
1.Males and Females age 21-89  
2.Ambulatory  
3.Chronic imbalance for at least 1 year  
4.Have reached a functional performance plateau with respect to their balance 
performance  
5.Have a DGI score of <19  
6.Fall below age and gender matched normative data for gait speed  
 
Exclusion criteria:  
1.Subjects who are unwilling or unable to adhere to all study requirements, 
including completion of the training period, evaluation tests, and return to clinic 

for a follow-up visit.  
2.Women who are pregnant (women will self report possible pregnancy).  
Recruitment:  
 
Participants are recruited from the population seen by the Department of 
Otolaryngology-Head and Neck Surgery. This is also where the research is 
conducted. The consent process and study visits will be conducted in a quiet, 
private exam room.  Records are kept securely under a triple lock system. Data 
reported is de-identified however coded.   
 
Design:   
 
One study group that consists of chronic postural instability. 
 
Procedures: (if applicable) 
 
The research will be conducted at the Center for Advanced Medicine (CAM) 
building  up to three occasions (week 1, week 6, and week 12). The first visit will 
last for approximately 2 hours. The second and third visits will last approximately 
1 hour each visit.  
 
During weeks 2, 3, 4, and 5 the “BALCAP” subjects will be asked to use the device 
(cap) daily for a prescribed period of time doing different activities. A physical 
therapist will provide them with written instructions that will be determined by their 
individual ability. These activities are typical exercises that are given to people with 
balance disorders and they might have been asked to do them previously. This 
time however, they will be asked to do them while wearing the cap that will provide 
them with cues. The subject will be asked to keep a diary of their daily use of the 
cap (time, duration, comments). They will be contacted weekly by the study 
coordinator via telephone to make sure they do not have any problems with the 
device or any questions. The “CONTROL” subjects will not take the device home 
for weeks 2,3,4 and 5 but will do the exercises that were prescribed by the physical 
therapist. After their week 6 evaluation they will transition and use the BALCAP 
device at home under the same conditions as the BALCAP subjects. The subjects 
who were assigned the balcap will go home and continue their exercises without 
the device. This will determine any lasting effects of the BALCAP device. Subjects 
will be randomly assigned to a group. 
 
If the subject had never completed the dynamic gait index test (DGI) or the gait 
speed test as part of their medical assessment or their results are not part of their 
medical record, they will be completed during the first visit. If the results from those 
two tests show that the subject’s balance problem is not significant enough to 
receive the cap, the subject will be excused at that time.  
 

During the first visit (week 1) the subject will complete the Computerized Dynamic 
Posturography (CDP) test, a spontaneous nystagmus test utilizing infra-red 
goggles while the vibration tactors are active to look for any resulting nystagmus, 
the DGI test, and the gait speed test. They will perform these tests both with and 
without the vibration stimulus from the cap. Finally, they will fill out two 
questionnaires. The Activities-specific Balance confidence (ABC) Scale and the 
Dizziness Handicap Inventory (DHI) questionnaires will also be completed.  
  
On the second visit (week 6) all testing completed during week 1 will be repeated. 
In addition, a third survey questionnaire will be completed asking about the design 
and comfort of the cap device for those in the BALCAP group. 
On the third visit (week 12) all testing completed during weeks 1 and 6 will be 
repeated and the design and comfort survey will be completed by those who just 
completed the BALCAP portion of the study. 
Ten subjects will be randomly selected to be interviewed by a third party 
determined by the sponsor to ask questions regarding the cap device and get more 
thorough usability input for future marketability. 
Follow-up:  
 
N/A