Vestibular DisorderNCT05436067
Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements
A study testing Vestibular rehabilitation app and Traditional Physical Therapy in people with Vestibular Disorder and Balance; Distorted, run by CFD Research Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Vestibular Disorder, Balance; Distorted, Vestibular Diseases
- What is being tested?
- Vestibular rehabilitation app and Traditional Physical Therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2022to 13 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 60 and 75
- Presence of dizziness due to a central or peripheral vestibular disorder
Who cannot join
- Presence of neurological disease such as stroke, multiple sclerosis, Parkinson's
- History of recent lower extremity surgery or severe pain in legs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: 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.
Read the 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.
- Conditions
- Vestibular Disorder, Balance; Distorted, Vestibular Diseases
- Being tested
- Vestibular rehabilitation app, Traditional Physical Therapy
- Keywords
- balance, telehealth, physical therapy, mobile application, serious gaming, rehabilitation, vestibular, dizziness
- Medical subject headings
- Vestibular Diseases, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular rehabilitation appDevice
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 TherapyOther
Delivery of vestibular rehabilitation through traditional physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Trials with Vestibular Rehabilitation App | Experimental | 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. Receives: Device: Vestibular rehabilitation app |
| Trials without Vestibular Rehabilitation App | Experimental | 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. Receives: Other: Traditional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: During the testing with the app and during the testing without the app (up to 90 minutes)
Secondary outcomes (1)
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?
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start23 May 2022
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vestibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CFD Research Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of Kansas Medical Center
- Responsible party
- Sponsor
- Investigators
- Paulien Roos, PhD, Principal investigator, CFD Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436067
- Sponsor's protocol ID
- STUDY00148324
- Other IDs
- 5R44DC017408-03
- Status last verified
- Mar 2025
- First submitted
- 6 Jun 2022
- Last updated
- 24 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 35280295Davis, 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.
PubMed 24966165
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an App for Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements
- ClinicalTrials.gov ID
- NCT05436067
- Acronym / sponsor ID
- STUDY00148324
- Conditions
- Vestibular Disorder, Balance; Distorted, Vestibular Diseases
- Keywords
- balance, telehealth, physical therapy, mobile application, serious gaming, rehabilitation, vestibular, dizziness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CFD Research CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of Kansas Medical Center
- Study start
- 23 May 2022 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Posted 24 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trials with Vestibular Rehabilitation App | Experimental | Device: Vestibular rehabilitation appAll 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. |
| Trials without Vestibular Rehabilitation App | Experimental | Other: Traditional Physical TherapyAll 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. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged between 60 and 75
- Presence of dizziness due to a central or peripheral vestibular disorder
Key exclusion criteria (2 listed)
- Presence of neurological disease such as stroke, multiple sclerosis, Parkinson's
- History of recent lower extremity surgery or severe pain in legs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular rehabilitation appDelivery 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. | Device | Trials with Vestibular Rehabilitation App |
| Traditional Physical TherapyDelivery of vestibular rehabilitation through traditional physical therapy. | Other | Trials without Vestibular Rehabilitation App |
Primary outcome
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.
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.
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.
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.
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
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
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
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.
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.
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.
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.
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.
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
1 secondary outcome
Open Ended Feedback
Time frame: Immediately after the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35280295DSilva 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.
- BackgroundDavis, F. D. Perceived Usefulness, Perceived Ease of Use, and User Acceptance of Information Technology. MIS Quarterly. 1989; 13(3): 319-340.
- BackgroundChin, 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.
- Background: PubMed 24966165van 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulien Roos, PhD principal investigator
CFD Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular rehabilitation app and Traditional Physical Therapy in people with Vestibular Disorder and Balance; Distorted, run by CFD Research Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Usefulness (time frame: Immediately after the testing). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05436067, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.