- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05627050
AR Training Platform at Home
Online AR Training Platform for the Elderly and Persons With Chronic Diseases at Home
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Raymond Kai-yu Tong, PhD
- Phone Number: +85239438454
- Email: kytong@cuhk.edu.hk
Study Locations
-
-
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Hong Kong, Hong Kong
- Recruiting
- Department of Biomedical Engineering, The Chinese University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age >=65 years old or suffering from chronic disease;
- sufficient cognition to follow simple instructions as well as understand the content and purpose of the study MoCA> 21); and
- Home setting: TV with HDMI input, internet access, and a distance of 1.5m away from TV.
Exclusion Criteria:
- Any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopaedic or chronic pain condition, major post-stroke depression, epilepsy, artificial cardiac pacemaker / joint;
- Severe shoulder or arm contracture/pain;
- Severe knee or hip contracture/pain;
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AR Training System
The subjects follow the daily rehabilitation training program designed by clinical and healthcare team.
The system will monitor their movement and provide feedbacks to the users.
The clinicians/healthcare workers can provide feedbacks and guidance to correct their movements and postures.
|
The hardware system is based on camera depth sensor and combined with 3D human tracking technology and intelligent technology, to monitor, correct and record the user's whole body movements in real-time, and the users can follow the training program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fugl-Meyer Assessment
Time Frame: 6-month after the first training
|
Fugl-Meyer Assessment for Upper-Extremity the maximum score is 66, divided into 33 items in the form of a 3-point scale (0-2), 0 is cannot perform and 2 performs fully. Fugl-Meyer Assessment for Lower-Extremity consists of 34-level cumulative scoring system to examine lower-limb functions of hemiplegic stroke patients quantitatively through a set of lower-limb movement tasks in reflex, flexor/extensor synergy, volitional movement, coordination and speed (Fugl-Meyer, et al., 1975). |
6-month after the first training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The 12-item Short Form Survey
Time Frame: 6-month after the first training
|
It is a self-reported outcome measure assessing the impact of health on an individual's everyday life.
It is often used as a quality-of-life measure.
|
6-month after the first training
|
Barthel Index
Time Frame: 6-month after the first training
|
It assesses functional independence, generally in stroke patients.
|
6-month after the first training
|
Berg Balance Scale
Time Frame: 6-month after the first training
|
Berg Balance Scale (BBS), consists of 56-level measures to examine balance ability and to predict falling risk with high reliability (ICC=0.98)
(Steffen, Hacker & Mollinger, 2002).
Stroke patients were assessed based on their performance on 14 simple mobility tasks, including transfer, standing, and reaching
|
6-month after the first training
|
Modified Ashworth Scale
Time Frame: 6-month after the first training
|
Modified Ashworth Scale (MAS), consists of 4-level scale to examine joint spasticity based on muscle tone and resistance detected during passive stretching with good inter-rater reliability (ICC =0.85) (Bohannon & Smith, 1987).
|
6-month after the first training
|
Functional Ambulation Category Test
Time Frame: 6-month after the first training
|
Functional Ambulatory Category (FAC) is a reliable measurement of independent walking ability on level-ground walking and stair ambulation, which is a good prediction of independent community walking post-stroke (Mehrholz, et al., 2007).
FAC consists of 6-level scale: patients with FAC=4 requires supervision in level ground walking, FAC=5 requires supervision only when walking on non-level surface such as stairs.
|
6-month after the first training
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Raymond Kai-yu Tong, PhD, Department of Biomedical Engineering, The Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020.538
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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