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Completed

NCT Number: NCT05436067

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.

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Key information

Conditions

Vestibular Disorder Balance; Distorted Dizziness Ear Diseases Labyrinth Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vestibular Diseases

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vestibular rehabilitation app

Device

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.

Traditional Physical therapy

Other

Delivery of vestibular rehabilitation through traditional physical therapy.

Primary outcomes

  1. Perceived Usefulness

    Time frame: 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.

  2. User Interface Satisfaction Questionnaire Outcomes

    Time frame: 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.

  3. Use Intention, Motivation and Enjoyment

    Time frame: 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.

  4. Change in Head Angle With the App

    Time frame: 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.

  5. Change in Range of Motion With the App

    Time frame: 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

  6. Change in Head Motion Frequency With the App

    Time frame: 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

  7. Change in Balance Outcome With the App - Weight Shift Exercise

    Time frame: 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

  8. Change in Head Angle With Feedback

    Time frame: 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.

  9. Change in Range of Motion With Feedback

    Time frame: 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.

  10. Change in Angular Velocity With Feedback

    Time frame: 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.

  11. Change in Balance Outcome With Feedback

    Time frame: 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.

  12. Error Identification Differences

    Time frame: 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.

  13. Change in Balance Outcome With the App - Single Leg Balance

    Time frame: 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 outcomes

  1. Open Ended Feedback

    Time frame: 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?

Sponsors and collaborators

Lead sponsor

CFD Research Corporation

Industry

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • University of Kansas Medical Center

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2022
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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