Clinical trial NCT05436067: 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
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Disorder
Balance; Distorted
Vestibular Diseases
Keywords: balance
telehealth
physical therapy
mobile application
serious gaming
rehabilitation
vestibular
dizziness
Lead sponsor: CFD Research Corporation
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: University of Kansas Medical Center
First posted: 2022-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Perceived Usefulness
timeFrame: Immediately after the testing
measure: User Interface Satisfaction Questionnaire Outcomes
timeFrame: Immediately after the testing
measure: Use Intention, Motivation and Enjoyment
timeFrame: Immediately after the testing
measure: Change in Head Angle With the App
timeFrame: During the testing with the app and during the testing without the app (up to 90 minutes)
measure: Change in Range of Motion With the App
timeFrame: During the testing with the app and during the testing without the app (up to 90 minutes)
measure: Change in Head Motion Frequency With the App
timeFrame: During the testing with the app and during the testing without the app (up to 90 minutes)
measure: Change in Balance Outcome With the App - Weight Shift Exercise
timeFrame: During the testing with the app and during the testing without the app (up to 90 minutes)
measure: Change in Head Angle With Feedback
timeFrame: During the testing with the app (up to 45 minutes)
measure: Change in Range of Motion With Feedback
timeFrame: During the intervention with the app (up to 45 minutes)
measure: Change in Angular Velocity With Feedback
timeFrame: During the intervention with the app (up to 45 minutes)
measure: Change in Balance Outcome With Feedback
timeFrame: During the intervention with the app (up to 45 minutes)
measure: Error Identification Differences
timeFrame: During the intervention with the app (up to 45 minutes)
measure: Change in Balance Outcome With the App - Single Leg Balance
timeFrame: During the testing with the app and during the testing without the app (up to 90 minutes)
Secondary outcomes:
measure: Open Ended Feedback
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: CFD Research Corporation
name: Paulien Roos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Davis, F. D. Perceived Usefulness, Perceived Ease of Use, and User Acceptance of Information Technology. MIS Quarterly. 1989; 13(3): 319-340.
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.
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.