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
2 other identifiers
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 23, 2022
CompletedFirst Submitted
Initial submission to the registry
June 6, 2022
CompletedFirst Posted
Study publicly available on registry
June 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2023
CompletedResults Posted
Study results publicly available
April 24, 2025
CompletedApril 24, 2025
March 1, 2025
8 months
June 6, 2022
October 6, 2023
April 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (13)
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 Outcomes (1)
Open Ended Feedback
Immediately after the intervention
Study Arms (2)
Trials with Vestibular Rehabilitation App
EXPERIMENTALAll 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
EXPERIMENTALAll 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.
Interventions
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.
Delivery of vestibular rehabilitation through traditional physical therapy.
Eligibility Criteria
You may qualify if:
- aged between 60 and 75
- Presence of dizziness due to a central or peripheral vestibular disorder
You may not qualify if:
- Presence of neurological disease such as stroke, multiple sclerosis, Parkinson's
- History of recent lower extremity surgery or severe pain in legs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Related Publications (4)
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.
PMID: 35280295BACKGROUNDDavis, 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.
BACKGROUNDvan 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.
PMID: 24966165BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Paulien Roos
- Organization
- CFD Research Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
Paulien Roos, PhD
CFD Research Corporation
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2022
First Posted
June 28, 2022
Study Start
May 23, 2022
Primary Completion
January 13, 2023
Study Completion
January 13, 2023
Last Updated
April 24, 2025
Results First Posted
April 24, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be available upon request after they have been published
- Access Criteria
- Upon request
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.