Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements

Not Applicable

Completed

Conditions: Balance; Distorted
Vestibular Disorder
Vestibular Diseases

Interventions: Device: Vestibular rehabilitation app

Registration Number: NCT05436067

Lead Sponsor: CFD Research Corporation

Brief Summary: The aim of this study is to test whether when using the Vestibular Rehabilitation App older patients perform rehabilitation in a similar manner as when directly instructed by a clinician. A secondary goal is to evaluate usability and enjoyment of the app.

Detailed Description: The main aim of this study is to test the prototype Vestibular Rehabilitation App (that has been specifically developed for this study) in the lab setting to evaluate if patients perform exercises with the app in a similar manner as when performing exercises in the traditional manner without the app. Errors in exercise performance identified by the app will be compared to those identified by a physical therapist. A secondary aim is to get feedback on enjoyment and ease of use of the Vestibular Rehabilitation App.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

Inclusion Criteria

aged between 60 and 75
Presence of dizziness due to a central or peripheral vestibular disorder

Exclusion Criteria

Presence of neurological disease such as stroke, multiple sclerosis, Parkinson's
History of recent lower extremity surgery or severe pain in legs

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Older adults with dizziness	Vestibular rehabilitation app	Clinical trial only has one arm or participant group. All participants undergo the same experiment. They will perform exercises with the Vestibular Rehabilitation App as well as without the App. The order is randomized.

Primary Outcome Measures

Name	Time	Method
Perceived Usefulness	Immediately after the testing	The ease of use of information technology questionnaire is used to rate usefulness and perceived ease of use of the Vestibular Rehabilitation app. These are rated on a scale of 1-7, with 1 being the most positive response, 4 being a neutral response and 7 being the most negative response.
User Interface Satisfaction Questionnaire Outcomes	Immediately after the testing	The questionnaire for user interface satisfaction (QUIS) is used to rate the Vestibular Rehabilitation app on use of its software and screen. These are rated on a scale of 0-9, with 9 being the most positive response and 0 being the most negative response.
Use Intention, Motivation and Enjoyment	Immediately after the testing	A questionnaire on use intention, motivation, and enjoyment is used to rate the Vestibular Rehabilitation app on the use intention, motivation and enjoyment of the app. These are rated on a scale of 1-7, with 1 being the most positive response, 4 being a neutral response and 7 being the most negative response.
Change in Head Angle With the App	During the testing with the app and during the testing without the app (up to 90 minutes)	The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate peak head angles. These were analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App.
Change in Range of Motion With the App	During the testing with the app and during the testing without the app (up to 90 minutes)	The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate head range of motion values. These were analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App
Change in Head Motion Frequency With the App	During the testing with the app and during the testing without the app (up to 90 minutes)	The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate frequency of head motion. These were analyzed to identify differences for the conditions (arms) with and without the Vestibular Rehabilitation App
Change in Balance Outcome With the App - Weight Shift Exercise	During the testing with the app and during the testing without the app (up to 90 minutes)	The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate range of motion in different directions during the weight shift balance exercise (in degrees). These were analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App
Change in Head Angle With Feedback	During the testing with the app (up to 45 minutes)	The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate peak head angles. Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given.
Change in Range of Motion With Feedback	During the intervention with the app (up to 45 minutes)	The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate range of motion values. Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given.
Change in Angular Velocity With Feedback	During the intervention with the app (up to 45 minutes)	The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate angular velocity values . Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given.
Change in Balance Outcome With Feedback	During the intervention with the app (up to 45 minutes)	The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate balance measures (jerk). Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given.
Error Identification Differences	During the intervention with the app (up to 45 minutes)	The exercise errors that are identified by the Vestibular Rehabilitation App and those identified by the physical therapist will be compared.
Change in Balance Outcome With the App - Single Leg Balance	During the testing with the app and during the testing without the app (up to 90 minutes)	The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate balance measure fluency (a non-dimensional derivative of jerk). This was analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App

Secondary Outcome Measures

Name	Time	Method
Open Ended Feedback	Immediately after the intervention	Participants will be asked for open ended feedback after the testing with and without the Vestibular Rehabilitation App. Discussions will be guided with questions. The questions were as follows: 1) Describe your overall experience as you used the app today?; 2) Explain the positive features of the app as you did your exercises?; 3) Describe the negative features of the app as you did your exercises today?; 4) What changes would you like to see in the app to support you as you do your exercises?; 5) Do you see any barriers to using the app while doing your exercises at home?