CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
Sensory Kinetics Balance System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01672658
NCT01672658N/ACompleted

Standard Vestibular Rehabilitation Training (VRT) vs. Sensory Kinetics Balance System (SKBS) + VRT on Balance and Functional Outcomes in the Mild Traumatic Brain Injury (mTBI) Population.

Shirley Ryan AbilityLab·interventional·Posted Aug 27, 2012·Updated Apr 4, 2016

In Brief

A clinical study evaluating Sensory Kinetics Balance System and Traditional Vestibular Rehabilitation for Traumatic Brain Injury and Vestibular Deficits. Completed, enrolled 31 participants across 1 site.

Detailed Summary

The goal of this clinical research study at RIC is to determine the value and benefit of the SK multimodal balance training system through independent clinical evaluations. The functional benefit of the SK Balance system will be measured by any improvements in balance and functional assessments. This study is primarily funded through Engineering Acoustics as a subcontract for a phase II Small Business Innovation Research by the Department of Defense. 3\) Hypotheses \& Research Objectives and Purpose: The specific research questions to be addressed are: 1. How does an 8-week SKBS+VRT training intervention compare to an 8-week standard VRT intervention on balance and functional gait measures in mild traumatic brain injury (mTBI) participants. 2. How do SKBS measurement tools compare to standard clinical assessments of gait and balance in mTBI patients The purpose of this clinical research study is to compare the value and benefit of the SK multimodal balance training system in combination with traditional vestibular rehabilitation vs. traditional vestibular rehabilitation alone through independent clinical evaluations. The functional benefit of the SK Balance system will be measured by any improvements in clinical measures of balance, functional mobility, and gait assessment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 27, 2012
Enrollment StartJan 1, 2012
Primary CompletionDec 1, 2013
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 13.8 years ago

Interventions

Sensory Kinetics Balance Systemdevice

Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.

Traditional Vestibular Rehabilitationother

Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.