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

Evaluation of an App for Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements

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.

Study Overview

• Status: Completed
• Conditions: Vestibular Diseases; Balance; Distorted; Vestibular Disorder
• Intervention / Treatment: Device: Vestibular rehabilitation app; Other: Traditional Physical Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trials with Vestibular Rehabilitation App; All participants underwent the same experiment. They will performed exercises with the Vestibular Rehabilitation App as well as without the App. The order was randomized. This arm describes the results of the trials where exercises were performed with the Vestibular Rehabilitation App.	Device: Vestibular rehabilitation app; Delivery of vestibular rehabilitation through an app on a tablet or other portable device. The app takes patients through their rehabilitation session that has been prescribed by a clinician. Exercises are presented in the forms of games that are controlled by head or torso motion via a motion sensor that is placed on that body part. Data on the motion of the patient are calculated from sensor data and sent over the cloud for the clinician to access remotely.
Experimental: Trials without Vestibular Rehabilitation App; All participants underwent the same experiment. They will performed exercises with the Vestibular Rehabilitation App as well as without the App. The order was randomized. This arm describes the results of the trials where exercises were performed without the Vestibular Rehabilitation App.	Other: Traditional Physical Therapy; Delivery of vestibular rehabilitation through traditional physical therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Usefulness	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.	Immediately after the testing
User Interface Satisfaction Questionnaire Outcomes	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.	Immediately after the testing
Use Intention, Motivation and Enjoyment	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.	Immediately after the testing
Change in Head Angle With the App	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.	During the testing with the app and during the testing without the app (up to 90 minutes)
Change in Range of Motion With the App	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	During the testing with the app and during the testing without the app (up to 90 minutes)
Change in Head Motion Frequency With the App	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	During the testing with the app and during the testing without the app (up to 90 minutes)
Change in Balance Outcome With the App - Weight Shift Exercise	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	During the testing with the app and during the testing without the app (up to 90 minutes)
Change in Head Angle With Feedback	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.	During the testing with the app (up to 45 minutes)
Change in Range of Motion With Feedback	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.	During the intervention with the app (up to 45 minutes)
Change in Angular Velocity With Feedback	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.	During the intervention with the app (up to 45 minutes)
Change in Balance Outcome With Feedback	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.	During the intervention with the app (up to 45 minutes)
Error Identification Differences	The exercise errors that are identified by the Vestibular Rehabilitation App and those identified by the physical therapist will be compared.	During the intervention with the app (up to 45 minutes)
Change in Balance Outcome With the App - Single Leg Balance	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	During the testing with the app and during the testing without the app (up to 90 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Open Ended Feedback	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?	Immediately after the intervention

Collaborators and Investigators

• Sponsor: CFD Research Corporation
• Collaborators: University of Kansas Medical Center; National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Paulien Roos, PhD, CFD Research Corporation

Publications and helpful links

General Publications

• DSilva LJ, Skop KM, Pickle NT, Marschner K, Zehnbauer TP, Rossi M, Roos PE. Use of Stakeholder Feedback to Develop an App for Vestibular Rehabilitation-Input From Clinicians and Healthy Older Adults. Front Neurol. 2022 Feb 24;13:836571. doi: 10.3389/fneur.2022.836571. eCollection 2022.
• Davis, F. D. Perceived Usefulness, Perceived Ease of Use, and User Acceptance of Information Technology. MIS Quarterly. 1989; 13(3): 319-340.
• Chin, J.P., Diehl, V.A., and Norman, K.L. Development of a tool measuring user satisfaction of the human-computer interface. CHI '88: Proceedings of the SIGCHI Conference on Human Factors in Computing Systems. 1988; 213-218.
• van Het Reve E, Silveira P, Daniel F, Casati F, de Bruin ED. Tablet-based strength-balance training to motivate and improve adherence to exercise in independently living older people: part 2 of a phase II preclinical exploratory trial. J Med Internet Res. 2014 Jun 25;16(6):e159. doi: 10.2196/jmir.3055.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Actual): January 13, 2023
• Study Completion (Actual): January 13, 2023

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: rehabilitation; vestibular; physical therapy; balance; dizziness; telehealth; mobile application; serious gaming
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Labyrinth Diseases; Vestibular Diseases
• Other Study ID Numbers: STUDY00148324; 5R44DC017408-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All resources developed for this project will be presented at conferences and published in the literature where possible. Whenever possible the investigators will include supplemental data (de-identified) in the online versions of their publications to most fully disseminate our results. Also, resources and de-identified data will be made available, whenever possible and appropriate, to qualified persons upon request.
• IPD Sharing Time Frame: Data will be available upon request after they have been published
• IPD Sharing Access Criteria: Upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No