Vibrotactile Feedback During Vestibular Therapy

Study Overview
=================
Brief Summary
-----------------
This study evaluates the use of vibrotactile feedback to traditional vestibular treatment protocols. Half the patients will have vibrotactile feedback added to their treatment protocols while the other half will undergo traditional vestibular treatment without vibrotactile feedback.

Detailed Description
-----------------
Vestibular and balance rehabilitation is an effective way to improve balance for individuals with balance impairments by using the strategies of adaptation, habituation, or substitution. Typical vestibular treatment is usually 3 sessions per week for 6 weeks. For people with uncompensated unilateral vestibular hypofunction or bilateral vestibular loss, recovery/adaptation is often incomplete and chronic balance impairments result. Vibrotactile feedback (VTF) is a strategy of substitution, or augmentation, to replace disrupted or absent vestibular function. The sensory information replaces disrupted or absent vestibular function to give persons additional signals about their body position in space. Real-time VTF applied to the trunk has been shown to decrease postural sway but the long-term benefits of training with VTF on balance and function have not been examined.

Official Title
-----------------
The Effects of Vibrotactile Feedback During Vestibular Rehabilitation

Conditions
-----------------
Vestibular Disease

Intervention / Treatment
-----------------
* Other: Vibrotactile Feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral peripheral vestibular hypofunction bilateral peripheral vestibular hypofunction Exclusion Criteria: confounding neurologic or neuromuscular disorders pregnancy inability to stand for 3 minutes recent lower extremity fracture/severe sprain within the last 6 months previous lower extremity joint replacement incapacitating back or lower extremity pain body too large for equipment

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibrotactile Feedback<br>Balance exercises completed while vibration was applied to the trunk (anterior, posterior, right, and left) if postural sway exceeded a pre-determined threshold during the exercise. | Other: Vibrotactile Feedback<br>* Balance training Vibrotactile feedback applied to the trunk<br>|
| No Intervention: Without Vibrotactile Feedback<br>Balance training without feedback | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sensory Organization Testing | Postural sway data will be collected during Computerized Dynamic Posturography using the NeuroCom Equitest. | Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks | 
| Change in 10-meter walk test | Participants preferred gait velocity will be assessed while walking in a straight path by timing 10-meter walk. | Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks | 
| Change in Dynamic Gait Index and Functional Gait Assessment | Measures that assess ability to modify walking in the presence of external demands. Includes tasks such walking with head turns, walking around obstacles, stepping over obstacles, and negotiating stairs. Each task is scored on a 4 point scale (0-3) and a total score is compiled. | Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks | 
| Change in Five Times Sit to Stand | A stopwatch is used to record the amount of time it takes the participant to move from a seated position to a standing position back to seated without using their hads for a total of 5 repetitions | Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Activities-specific Balance Confidence Scale | A 16-item self-report instrument which the participants completes by scoring their perceived confidence level during activities of daily living. | Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks | 
| Change in Dizziness Handicap Inventory | A self-report instrument which the participants indicates whether or not the listed 25 activities cause dizziness. | Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks | 
| Change in Short Form-12 | A 12 question self-report instrument that provide information about mental and physical functioning as well as health-related quality of life | Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vibrotactile feedback, vestibular rehabilitation, balance