Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements
Primary Purpose
Vestibular Disorder, Balance; Distorted, Vestibular Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vestibular rehabilitation app
Sponsored by
About this trial
This is an interventional other trial for Vestibular Disorder focused on measuring balance, telehealth, physical therapy, mobile application, serious gaming, rehabilitation, vestibular, dizziness
Eligibility Criteria
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
Sites / Locations
- University of Kansas Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Older adults with dizziness
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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
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
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
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.
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.
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.
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.
Error identification differences
The exercise errors that are identified by the Vestibular Rehabilitation App and those identified by the physical therapist will be compared.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05436067
First Posted
June 6, 2022
Last Updated
September 14, 2022
Sponsor
CFD Research Corporation
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05436067
Brief Title
Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements
Official Title
Evaluation of an App for Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CFD Research Corporation
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), University of Kansas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Disorder, Balance; Distorted, Vestibular Diseases
Keywords
balance, telehealth, physical therapy, mobile application, serious gaming, rehabilitation, vestibular, dizziness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Older adults with dizziness
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Vestibular rehabilitation app
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perceived usefulness
Description
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.
Time Frame
Immediately after the intervention
Title
User interface satisfaction questionnaire outcomes
Description
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.
Time Frame
Immediately after the intervention
Title
Use intention, motivation and enjoyment
Description
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.
Time Frame
Immediately after the intervention
Title
Change in head angle with the app
Description
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.
Time Frame
During the intervention with the app and during the intervention without the app (up to 90 minutes)
Title
Change in range of motion with the app
Description
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
Time Frame
During the intervention with the app and during the intervention without the app (up to 90 minutes)
Title
Change in angular velocity with the app
Description
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
Time Frame
During the intervention with the app and during the intervention without the app (up to 90 minutes)
Title
Change in balance outcome with the app
Description
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
Time Frame
During the intervention with the app and during the intervention without the app (up to 90 minutes)
Title
Change in head angle with feedback
Description
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.
Time Frame
During the intervention with the app (up to 45 minutes)
Title
Change in range of motion with feedback
Description
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.
Time Frame
During the intervention with the app (up to 45 minutes)
Title
Change in angular velocity with feedback
Description
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.
Time Frame
During the intervention with the app (up to 45 minutes)
Title
Change in balance outcome with feedback
Description
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.
Time Frame
During the intervention with the app (up to 45 minutes)
Title
Error identification differences
Description
The exercise errors that are identified by the Vestibular Rehabilitation App and those identified by the physical therapist will be compared.
Time Frame
During the intervention with the app (up to 45 minutes)
Secondary Outcome Measure Information:
Title
Open ended feedback
Description
Participants will be asked for open ended feedback after the testing with and without the Vestibular Rehabilitation App. Discussions will be guided with questions.
Time Frame
Immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paulien Roos, PhD
Phone
2567156817
Email
paulien.roos@cfd-research.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eddie McAbee
Phone
2563610817
Email
contracts@cfd-research.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulien Roos, PhD
Organizational Affiliation
CFD Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda D'Silva, PhD
Phone
913-588-4343
Email
ldsilva@kumc.edu
First Name & Middle Initial & Last Name & Degree
Linda D'Silva, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be available upon request after they have been published
IPD Sharing Access Criteria
Upon request
Citations:
PubMed Identifier
35280295
Citation
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.
Results Reference
background
Citation
Davis, F. D. Perceived Usefulness, Perceived Ease of Use, and User Acceptance of Information Technology. MIS Quarterly. 1989; 13(3): 319-340.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
24966165
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.
Results Reference
background
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Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements
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