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NCT05436067

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

Completed NA Results posted Last updated 24 April 2025
What this trial tests

NA trial testing Vestibular rehabilitation app in Vestibular Disorder in 40 participants. Completed in 13 January 2023.

Timeline
23 May 2022
Primary endpoint
13 January 2023
13 January 2023

Quick facts

Lead sponsorCFD Research Corporation
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposeother
Enrollment40
Start date23 May 2022
Primary completion13 January 2023
Estimated completion13 January 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

CFD Research Corporation

Who can join

Adults 60 to 75, any sex, with Vestibular Disorder or Balance; Distorted. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Perceived Usefulness Primary · 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.

GroupValue95% CI
Older Adults With Dizziness1.99± 1.00
User Interface Satisfaction Questionnaire Outcomes Primary · 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.

GroupValue95% CI
Older Adults With Dizziness7.59± 1.70
Use Intention, Motivation and Enjoyment Primary · 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.

GroupValue95% CI
Older Adults With Dizziness1.90± 1.13
Change in Head Angle With the App Primary · 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.

Peak pitch angle - left
GroupValue95% CI
Trials With the Vestibular Rehabilitation App13.2± 6.9
Trials Without the Vestibular Rehabilitation App22.0± 8.3
Peak pitch angle - right
GroupValue95% CI
Trials With the Vestibular Rehabilitation App13.8± 7.8
Trials Without the Vestibular Rehabilitation App21.4± 8.2
Peak yaw angle - flexion
GroupValue95% CI
Trials With the Vestibular Rehabilitation App13.6± 6.0
Trials Without the Vestibular Rehabilitation App16.0± 13.2
Peak yaw angle - extension
GroupValue95% CI
Trials With the Vestibular Rehabilitation App14.7± 5.7
Trials Without the Vestibular Rehabilitation App16.5± 10.8
Change in Range of Motion With the App Primary · 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

Range of motion - yaw
GroupValue95% CI
Trials With the Vestibular Rehabilitation App14.1± 5.3
Trials Without Vestibular Rehabilitation App16.6± 7.0
Range of motion - pitch
GroupValue95% CI
Trials With the Vestibular Rehabilitation App13.6± 7.0
Trials Without Vestibular Rehabilitation App22.9± 9.7
Change in Head Motion Frequency With the App Primary · 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

Pitch frequency
GroupValue95% CI
Trials With the Vestibular Rehabilitation App0.93± 0.1
Trials Without the Vestibular Rehabilitation App0.93± 0.27
Yaw frequency
GroupValue95% CI
Trials With the Vestibular Rehabilitation App0.93± 0.13
Trials Without the Vestibular Rehabilitation App0.85± 0.27
Change in Balance Outcome With the App - Weight Shift Exercise Primary · 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

Weight shift exercise - mediolateral range of motion
GroupValue95% CI
Trials With the Vestibular Rehabilitation App8.7± 3.5
Trials Without the Vestibular Rehabilitation App7.2± 3.5
Weight shift exercise - anterioposterior range of motion
GroupValue95% CI
Trials With the Vestibular Rehabilitation App4.5± 1.6
Trials Without the Vestibular Rehabilitation App3.7± 1.7
Single leg balance - range of motion
GroupValue95% CI
Trials With the Vestibular Rehabilitation App8.8± 4.8
Trials Without the Vestibular Rehabilitation App11.0± 6.8
Open Ended Feedback Secondary · 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?

Overall experience - not challenging
GroupValue95% CI
Trials With Vestibular Rehabilitation App1
Trials Without Vestibular Rehabilitation App0
Overall experience - positive or fun
GroupValue95% CI
Trials With Vestibular Rehabilitation App30
Trials Without Vestibular Rehabilitation App0
Overall experience - easy or easy to understand
GroupValue95% CI
Trials With Vestibular Rehabilitation App11
Trials Without Vestibular Rehabilitation App0
Overall experience - engaging or interesting
GroupValue95% CI
Trials With Vestibular Rehabilitation App6
Trials Without Vestibular Rehabilitation App0
Overall experience - motivating
GroupValue95% CI
Trials With Vestibular Rehabilitation App9
Trials Without Vestibular Rehabilitation App0
Overall experience - difficult
GroupValue95% CI
Trials With Vestibular Rehabilitation App1
Trials Without Vestibular Rehabilitation App0
Overall experience - seems geared toward more younger adults
GroupValue95% CI
Trials With Vestibular Rehabilitation App5
Trials Without Vestibular Rehabilitation App0
Overall experience - not motivating
GroupValue95% CI
Trials With Vestibular Rehabilitation App2
Trials Without Vestibular Rehabilitation App0
Change in Balance Outcome With the App - Single Leg Balance Primary · 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

GroupValue95% CI
Trials With the Vestibular Rehabilitation App0.28± 0.07
Trials Without the Vestibular Rehabilitation App0.30± 0.07

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A gaming app developed for vestibular rehabilitation improves the accuracy of performance and engagement with exercises.
    D'Silva LJ, Phongsavath T, Partington K, Pickle NT, et al · · 2023 · cited 3× · PMID 38076248 · DOI 10.3389/fmed.2023.1269874

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Other recruiting trials for Vestibular Disorder

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05436067.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing