Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness
This pilot study is focused on what assistance an external prosthetic device, the BalanceBeltTM can provide in the: 1) assessment and 2) treatment for patients with Chronic Subjective Dizziness (CSD). The BalanceBelt has sensitive detectors for movement in the anterior/posterior and medial/lateral planes and provides the person wearing the device vibro-tactile feedback as to the persons orientation with respect to gravity. The device is a full self contained device that is comfortably worn around the waist over a light weight shirt. The device is non-FDA approved and is in its final stages of beta testing. Patients with CSD do not have permanent vestibular deficits, but underutilize vestibular signals because they develop visual or somatosensory dependence. The investigators expect the BalanceBeltTM to reset this error by providing patients with reliable motion stimuli.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Project to Investigate the Use of an External Vestibular Prosthesis Potential to Improve Clinical Management of Chronic Subjective Dizziness (CSD)|
- Significant difference (p<0.05) in sway magnitude fore and aft / right left between CSD patients and the age and gender matched controls [ Time Frame: 8 months after the start of the assessment study protion ] [ Designated as safety issue: No ]The measures of sway will be recorded on the BalanceBelt without feedback to the subjects. These measures of sway will represent the average sway of the patient (CSD) group and the control group.
- Visual Analog Scales [ Time Frame: 1 year after the start of the therapy study portion ] [ Designated as safety issue: No ]For the therapy portion of the study aim #2 Visual Analog Scales related to the intensity of symptoms provoked by visual motion, head movements and walking in visually complex environments. These same measures will be taken at the begining and end of the one week of intensive therapy. The average Visual Analog Scale scores for the patient group pre and post therapy will be compared for any significant difference in the score (p<0.05).
|Study Start Date:||October 2014|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Experimental: Vestibular Habituation Therapy
Device: Balance Belt
Vestibular habituation therapy for sensitivity to visual motion, visual complex environments, head movements and visual patterns. The exercises will have 3-5 repetitions for each of the head movement or visual stimuli that cause and increase in the symptoms of unsteadiness or self motion. These exercises will be done while wearing the Balance Belt for feedback information as to how much the patient is swaying.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02048670
|Contact: Neil T Shepard, PhD||507 538 firstname.lastname@example.org|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Neil T. Shepard, Ph.D 507-266-1965 email@example.com|
|Principal Investigator:||Neil Shepard, PhD||Mayo Clinic|