Clinical trial NCT03330262: Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
Official title: Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Disorder
Dizziness
Keywords: Postural Instability
Balance Disorder
Balance Prosthesis
Dizziness
Lead sponsor: Barron Associates, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Washington University School of Medicine
First posted: 2017-11-06
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The goal of this study is to evaluate a tactile prosthesis that provide individuals who have demonstrated chronic imbalance with help to maintain a correct sense of orientation with respect to the gravity and improve posture control.

Detailed description: The goal of this study is to evaluate a tactile prosthesis that provide individuals who have demonstrated chronic imbalance with help to maintain a correct sense of orientation with respect to the gravity and improve posture control. Chronic imbalance leads to significant problems. This study is designed to evaluate a device which can potentially improve the balance of these patients.

The participant will be asked to come to Washington University on three occasions for approximately 2 hours. Between visits, they will be asked to use the device daily (intervention condition) or to not use the device (control condition) for a prescribed period of time doing different activities. They will be provided written instructions from a physical therapist that will be determined by their individual ability. The activities will be typical exercises that are given to people with balance disorders. After 6 weeks of home use, participants will return for the second visit, and will repeat the evaluation. They will then return home and complete the either the control or intervention condition (which was not done the first time) in a crossover design.

On their first visit (week 0; baseline) participants will be asked to complete the same kind of tests that evaluated the function of their balance system at the time of their diagnosis. They will have their eye movements recorded using goggles and an infra-red camera while the prosthesis is in place and providing vibration feedback. Computerized Dynamic Posturography (CDP) testing will require them to stand on a platform and perform tests (20 seconds each) with their eyes open or closed, with the platform moving or still, and/or with the visual surround either stable or moving. They will be fitted with a safety harness that will keep them from falling. Next the investigators will evaluate their ability to perform movement tasks while walking (walking down the hall, walking down the hall avoiding objects, changing speeds while walking, going up and down stairs etc). They will walk a 25-foot distance at a comfortable gait speed, and again at a maximum gait speed. Lastly, they will be asked to fill out questionnaires.

On their second and last visit, they will repeat the evaluations that were performed during the first visit.

Eligibility criteria: Inclusion Criteria:

* Ambulatory
* Chronic imbalance for at least 1 year
* Have reached a functional performance plateau with respect to balance performance
* Have a DGI score of \<19
* Fall below age and gender matched normative data for gait speed

Exclusion Criteria:

* 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.
* Women who are pregnant (women will self-report possible pregnancy).

Primary outcomes:
measure: Difference in Dynamic Gait Index (DGI)
timeFrame: Week 0 (baseline)
Secondary outcomes:
measure: Change in Computerized Dynamic Posturography: Equilibrium Score
timeFrame: Before and after 6 weeks of either the intervention or the control condition
measure: Difference in Gait Speed
timeFrame: Week 0 (baseline)
measure: Change in Activities-specific Balance Confidence (ABC) Scale
timeFrame: Before and after 6 weeks of either the intervention or the control condition
measure: Change in Dizziness Handicap Inventory Score
timeFrame: Before and after 6 weeks of either the intervention or the control condition
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Barron Associates, Inc.
name: Eugene Parker, PHD
role: PRINCIPAL_INVESTIGATOR
References: