Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements

NCT ID: NCT05436067

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-23
• Study Completion Date: 2023-01-13

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.

Conditions

Vestibular Disorder; Balance; Distorted; Vestibular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Trials with Vestibular Rehabilitation App

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.

Group Type: EXPERIMENTAL

Vestibular rehabilitation app

Intervention Type: DEVICE

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.

Trials without Vestibular Rehabilitation App

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.

Group Type: EXPERIMENTAL

Traditional Physical Therapy

Intervention Type: OTHER

Delivery of vestibular rehabilitation through traditional physical therapy.

Interventions

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.

Intervention Type: DEVICE

Traditional Physical Therapy

Delivery of vestibular rehabilitation through traditional physical therapy.

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: collaborator

CFD Research Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paulien Roos, PhD

Role: PRINCIPAL_INVESTIGATOR

CFD Research Corporation

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 35280295 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 24966165 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R44DC017408-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00148324

Identifier Type: -

Identifier Source: org_study_id