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临床试验/NCT05436067
NCT05436067已完成不适用

Evaluation of an App for Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements

CFD Research Corporation2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Perceived Usefulness

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged between 60 and 75
  • Presence of dizziness due to a central or peripheral vestibular disorder

排除标准

  • Presence of neurological disease such as stroke, multiple sclerosis, Parkinson's
  • History of recent lower extremity surgery or severe pain in legs

结局指标

主要结局

Perceived Usefulness

时间窗: Immediately after the testing

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

时间窗: Immediately after the testing

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

时间窗: Immediately after the testing

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

时间窗: During the testing with the app and during the testing without the app (up to 90 minutes)

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.

Change in Range of Motion With the App

时间窗: During the testing with the app and during the testing without the app (up to 90 minutes)

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

Change in Head Motion Frequency With the App

时间窗: During the testing with the app and during the testing without the app (up to 90 minutes)

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

Change in Balance Outcome With the App - Weight Shift Exercise

时间窗: During the testing with the app and during the testing without the app (up to 90 minutes)

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

Change in Head Angle With Feedback

时间窗: During the testing with the app (up to 45 minutes)

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

时间窗: During the intervention with the app (up to 45 minutes)

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

时间窗: During the intervention with the app (up to 45 minutes)

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

时间窗: During the intervention with the app (up to 45 minutes)

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

时间窗: During the intervention with the app (up to 45 minutes)

The exercise errors that are identified by the Vestibular Rehabilitation App and those identified by the physical therapist will be compared.

Change in Balance Outcome With the App - Single Leg Balance

时间窗: During the testing with the app and during the testing without the app (up to 90 minutes)

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

次要结局

  • Open Ended Feedback(Immediately after the intervention)

研究者

发起方
CFD Research Corporation
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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