N/A
N=13
Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
Vestibular Disorder · Dizziness
Bottom Line
View on ClinicalTrials.gov: NCT03330262 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Difference in Dynamic Gait Index (DGI) — 0.77 units on a scale — p=0.018
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BALCAP prosthesis (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Barron Associates, Inc.
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Dynamic Gait Index (DGI) |
0.77 | 0.018 sig |
| SECONDARY Change in Computerized Dynamic Posturography: Equilibrium Score |
5.94; 0.34 | 0.006 sig |
| SECONDARY Difference in Gait Speed |
0.03 | 0.448 |
| SECONDARY Change in Activities-specific Balance Confidence (ABC) Scale |
6.04; 1.39 | 0.273 |
| SECONDARY Change in Dizziness Handicap Inventory Score |
-7.33; 2.00 | 0.189 |
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.
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).
Data sourced from ClinicalTrials.gov (NCT03330262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.