Vibrotactile Feedback During Vestibular Therapy
|ClinicalTrials.gov Identifier: NCT02867683|
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : February 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Vestibular Disease||Other: Vibrotactile Feedback||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effects of Vibrotactile Feedback During Vestibular Rehabilitation|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||August 1, 2017|
|Actual Study Completion Date :||January 31, 2018|
Experimental: Vibrotactile Feedback
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
Balance training Vibrotactile feedback applied to the trunk
No Intervention: Without Vibrotactile Feedback
Balance training without feedback
- Change in Sensory Organization Testing [ Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks ]Postural sway data will be collected during Computerized Dynamic Posturography using the NeuroCom Equitest.
- Change in 10-meter walk test [ Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks ]Participants preferred gait velocity will be assessed while walking in a straight path by timing 10-meter walk.
- Change in Dynamic Gait Index and Functional Gait Assessment [ Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks ]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.
- Change in Five Times Sit to Stand [ Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks ]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
- Change in Activities-specific Balance Confidence Scale [ Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks ]A 16-item self-report instrument which the participants completes by scoring their perceived confidence level during activities of daily living.
- Change in Dizziness Handicap Inventory [ Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks ]A self-report instrument which the participants indicates whether or not the listed 25 activities cause dizziness.
- Change in Short Form-12 [ Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks ]A 12 question self-report instrument that provide information about mental and physical functioning as well as health-related quality of life
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867683
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15224|