Phase 1
N=5
Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
Dizziness
Bottom Line
View on ClinicalTrials.gov: NCT00889824 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks. — 4.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- balance prosthesis (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks. |
4.3 | — |
Summary
The goal of this project is to provide individuals that have a balance deficit with a device that will give them signals that they can feel (vibrations) in order to help them maintain a correct sense of balance and perception of place in the environment.
Eligibility Criteria
Inclusion Criteria
- Ambulatory patients who have had chronic imbalance for at least one year, and have reached a functional performance plateau with respect to their balance adaptation.
Exclusion Criteria
- Neurological disorders other than chronic balance disorders, as determined by medical history and neurological screening procedure.
- Any medical condition as determined by the health questionnaire that would interfere with performance on the postural stability evaluation tests.
- Peripheral neuropathies of the lower extremities.
- 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.
Data sourced from ClinicalTrials.gov (NCT00889824). 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.