Trial Outcomes & Findings for Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements (NCT NCT05436067)

Last Updated: 2025-04-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

During the testing with the app (up to 45 minutes)

Results posted on

2025-04-24

Participant Flow

A total of 40 participants were recruited and participated in this study.

Participant milestones

Participant milestones
Measure	Older Adults With Dizziness All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App. The order was randomized.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study Population n=40 Participants 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. In the rest of the reporting the overall study population is presented in two different arms, "Trials with Vestibular Rehabilitation App" and "Trials without Vestibular Rehabilitation App". These are the same participants and all participated in both arms.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	28 Participants n=5 Participants
Age, Continuous	67.65 years STANDARD_DEVIATION 4.76 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Older Adults With Dizziness n=40 Participants 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. 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.	Trials Without the Vestibular Rehabilitation App All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials without the Vestibular Rehabilitation App.
Perceived Usefulness	1.99 units on a scale Standard Deviation 1.00	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Older Adults With Dizziness n=40 Participants 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. 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.	Trials Without the Vestibular Rehabilitation App All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials without the Vestibular Rehabilitation App.
User Interface Satisfaction Questionnaire Outcomes	7.59 units on a scale Standard Deviation 1.70	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Older Adults With Dizziness n=40 Participants 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. 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.	Trials Without the Vestibular Rehabilitation App All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials without the Vestibular Rehabilitation App.
Use Intention, Motivation and Enjoyment	1.90 units on a scale Standard Deviation 1.13	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Older Adults With Dizziness n=40 Participants 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. 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.	Trials Without the Vestibular Rehabilitation App n=40 Participants All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials without the Vestibular Rehabilitation App.
Change in Head Angle With the App Peak yaw angle - flexion	13.6 degrees Standard Deviation 6.0	16.0 degrees Standard Deviation 13.2
Change in Head Angle With the App Peak pitch angle - left	13.2 degrees Standard Deviation 6.9	22.0 degrees Standard Deviation 8.3
Change in Head Angle With the App Peak pitch angle - right	13.8 degrees Standard Deviation 7.8	21.4 degrees Standard Deviation 8.2
Change in Head Angle With the App Peak yaw angle - extension	14.7 degrees Standard Deviation 5.7	16.5 degrees Standard Deviation 10.8

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Older Adults With Dizziness n=40 Participants 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. 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.	Trials Without the Vestibular Rehabilitation App n=40 Participants All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials without the Vestibular Rehabilitation App.
Change in Range of Motion With the App Range of motion - yaw	14.1 degrees Standard Deviation 5.3	16.6 degrees Standard Deviation 7.0
Change in Range of Motion With the App Range of motion - pitch	13.6 degrees Standard Deviation 7.0	22.9 degrees Standard Deviation 9.7

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Older Adults With Dizziness n=40 Participants 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. 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.	Trials Without the Vestibular Rehabilitation App n=40 Participants All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials without the Vestibular Rehabilitation App.
Change in Head Motion Frequency With the App Pitch frequency	0.93 Hz Standard Deviation 0.1	0.93 Hz Standard Deviation 0.27
Change in Head Motion Frequency With the App Yaw frequency	0.93 Hz Standard Deviation 0.13	0.85 Hz Standard Deviation 0.27

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Older Adults With Dizziness n=40 Participants 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. 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.	Trials Without the Vestibular Rehabilitation App n=40 Participants All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials without the Vestibular Rehabilitation App.
Change in Balance Outcome With the App - Weight Shift Exercise Weight shift exercise - mediolateral range of motion	8.7 degrees Standard Deviation 3.5	7.2 degrees Standard Deviation 3.5
Change in Balance Outcome With the App - Weight Shift Exercise Weight shift exercise - anterioposterior range of motion	4.5 degrees Standard Deviation 1.6	3.7 degrees Standard Deviation 1.7
Change in Balance Outcome With the App - Weight Shift Exercise Single leg balance - range of motion	8.8 degrees Standard Deviation 4.8	11.0 degrees Standard Deviation 6.8

PRIMARY outcome

Timeframe: During the testing with the app (up to 45 minutes)

Population: No participants were analyzed because too few participants received feedback during the trials. For participants that did receive feedback the time window before and after the feedback varied widely, since feedback could be provided at any point in time during the trial. Due to these inconsistencies it was decided not to perform any statistically analyses on these data or to extract and analyze these data.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: During the intervention with the app (up to 45 minutes)

Timeframe: Immediately after the intervention

Population: The open ended questions referred to the use of the Vestibular Rehabilitation App and were therefore only filled out with regards to the arm "Trials with the Vestibular Rehabilitation App"

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?

Outcome measures

Outcome measures
Measure	Older Adults With Dizziness n=40 Participants 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. 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.	Trials Without the Vestibular Rehabilitation App All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials without the Vestibular Rehabilitation App.
Open Ended Feedback Overall experience - seems geared toward more younger adults	5 Participants	0 Participants
Open Ended Feedback Overall experience - not challenging	1 Participants	0 Participants
Open Ended Feedback Overall experience - positive or fun	30 Participants	0 Participants
Open Ended Feedback Would like - nothing, good as is	14 Participants	0 Participants
Open Ended Feedback Overall experience - easy or easy to understand	11 Participants	0 Participants
Open Ended Feedback Overall experience - engaging or interesting	6 Participants	0 Participants
Open Ended Feedback Overall experience - motivating	9 Participants	0 Participants
Open Ended Feedback Overall experience - difficult	1 Participants	0 Participants
Open Ended Feedback Overall experience - not motivating	2 Participants	0 Participants
Open Ended Feedback Overall experience - challenging (in a positive way)	2 Participants	0 Participants
Open Ended Feedback Overall experience - reduced anxiety	1 Participants	0 Participants
Open Ended Feedback Positive features - fun	5 Participants	0 Participants
Open Ended Feedback Would like - sound effects	4 Participants	0 Participants
Open Ended Feedback Positive features - motivating	5 Participants	0 Participants
Open Ended Feedback Positive features - provides feedback	3 Participants	0 Participants
Open Ended Feedback Positive features - challenging	1 Participants	0 Participants
Open Ended Feedback Positive features - colorful	2 Participants	0 Participants
Open Ended Feedback Positive features - easy to use	4 Participants	0 Participants
Open Ended Feedback Positive features - helpful	2 Participants	0 Participants
Open Ended Feedback Positive feedback - seeing progress or accomplishments	2 Participants	0 Participants
Open Ended Feedback Positive feedback - liked scoring or rewards	2 Participants	0 Participants
Open Ended Feedback Positive feedback - liked the gaming element	2 Participants	0 Participants
Open Ended Feedback Negative features - none noted	19 Participants	0 Participants
Open Ended Feedback Negative features - feedback interrupted flow	2 Participants	0 Participants
Open Ended Feedback Negative feedback - redundant instructions	2 Participants	0 Participants
Open Ended Feedback Negative feedback - frustration with motion control	6 Participants	0 Participants
Open Ended Feedback Negative feedback - learning curve	1 Participants	0 Participants
Open Ended Feedback Negative feedback - transition from weight shifting to balance games was challenging	1 Participants	0 Participants
Open Ended Feedback Negative feedback - juvenile theme	5 Participants	0 Participants
Open Ended Feedback Negative feedback - longer setup than traditional therapy	1 Participants	0 Participants
Open Ended Feedback Negative feedback - may get boring after a while	1 Participants	0 Participants
Open Ended Feedback Negative feedback - colors may be hard with color blindness in some games	1 Participants	0 Participants
Open Ended Feedback Would like - motion sensing improvement	2 Participants	0 Participants
Open Ended Feedback Would like - larger screen or font	4 Participants	0 Participants
Open Ended Feedback Would like - more rewards	1 Participants	0 Participants
Open Ended Feedback Would like - phone version	1 Participants	0 Participants
Open Ended Feedback Would like - wider variety of games	3 Participants	0 Participants
Open Ended Feedback Would like - different theme	4 Participants	0 Participants
Open Ended Feedback Would like - color blind accessibility	1 Participants	0 Participants
Open Ended Feedback Would like - demo video / real human demonstration	2 Participants	0 Participants
Open Ended Feedback Would like - personalization	3 Participants	0 Participants
Open Ended Feedback Would like - multi-player version	1 Participants	0 Participants
Open Ended Feedback Barriers - none	16 Participants	0 Participants
Open Ended Feedback Barriers - may be hard for older population to get used to technology	1 Participants	0 Participants
Open Ended Feedback Barriers - Setup at home and safety	3 Participants	0 Participants
Open Ended Feedback Barriers - learning how to use the app	1 Participants	0 Participants
Open Ended Feedback Barriers - equipment (tablet and stand) and equipment setup	14 Participants	0 Participants
Open Ended Feedback Barriers - cell phone version would be needed	1 Participants	0 Participants
Open Ended Feedback Barriers - cost	1 Participants	0 Participants
Open Ended Feedback Barriers - needing family members to help with setup	1 Participants	0 Participants
Open Ended Feedback Barriers - adherence to exercises	1 Participants	0 Participants

Adverse Events

Older Adults With Dizziness

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Paulien Roos

CFD Research Corporation

Phone: 256 715 6817

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place