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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05436067
Other study ID # STUDY00148324
Secondary ID 5R44DC017408-03
Status Recruiting
Phase N/A
First received
Last updated
Start date May 23, 2022
Est. completion date May 31, 2023

Study information

Verified date September 2022
Source CFD Research Corporation
Contact Paulien Roos, PhD
Phone 2567156817
Email paulien.roos@cfd-research.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date May 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 60 Years to 75 Years
Eligibility 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

Study Design


Intervention

Device:
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.

Locations

Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (3)

Lead Sponsor Collaborator
CFD Research Corporation National Institute on Deafness and Other Communication Disorders (NIDCD), University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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.

Davis, F. D. Perceived Usefulness, Perceived Ease of Use, and User Acceptance of Information Technology. MIS Quarterly. 1989; 13(3): 319-340.

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 intervention
Primary 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 intervention
Primary 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 intervention
Primary Change in head angle with the app The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App will be analyzed to calculate peak head angles. These will be analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App. During the intervention with the app and during the intervention without the app (up to 90 minutes)
Primary Change in range of motion with the app The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App will be analyzed to calculate head range of motion values. These will be analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App During the intervention with the app and during the intervention without the app (up to 90 minutes)
Primary Change in angular velocity with the app The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App will be analyzed to calculate angular velocity values. These will be analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App During the intervention with the app and during the intervention without the app (up to 90 minutes)
Primary Change in balance outcome with the app The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App will be analyzed to calculate balance measures (jerk). These will be analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App During the intervention with the app and during the intervention without the app (up to 90 minutes)
Primary 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 intervention with the app (up to 45 minutes)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Secondary 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. Immediately after the intervention
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