Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness
|ClinicalTrials.gov Identifier: NCT02048670|
Recruitment Status : Unknown
Verified May 2016 by Neil T. Shepard, Ph.D., Mayo Clinic.
Recruitment status was: Recruiting
First Posted : January 29, 2014
Last Update Posted : May 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Dizziness Chronic||Device: Balance Belt||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Project to Investigate the Use of an External Vestibular Prosthesis Potential to Improve Clinical Management of Chronic Subjective Dizziness (CSD)|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2017|
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.
- 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 ]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 ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|