Back to resultsAR Training Platform at Home
Primary Purpose
Stroke, Chronic Disease
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
An Online Augmented Reality (AR) Training Platform
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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
Sites / Locations
- Department of Biomedical Engineering, The Chinese University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AR Training System
Arm Description
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.
Outcomes
Primary Outcome Measures
Fugl-Meyer Assessment
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).
Secondary Outcome Measures
The 12-item Short Form Survey
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.
Barthel Index
It assesses functional independence, generally in stroke patients.
Berg Balance Scale
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
Modified Ashworth Scale
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).
Functional Ambulation Category Test
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.
Full Information
NCT ID
NCT05627050
First Posted
November 16, 2022
Last Updated
November 16, 2022
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05627050
Brief Title
AR Training Platform at Home
Official Title
Online AR Training Platform for the Elderly and Persons With Chronic Diseases at Home
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Video Communications, like ZOOM, have been widely used in the time of this epidemic. But how about to design an AR / VR communication system with coaching from clinician to facilitate training at home in this time of epidemic. Vulnerable individuals at home can interact with the training platform and his/her clinician can provide online training progamme with guidance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Chronic Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AR Training System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
An Online Augmented Reality (AR) Training Platform
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment
Description
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).
Time Frame
6-month after the first training
Secondary Outcome Measure Information:
Title
The 12-item Short Form Survey
Description
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.
Time Frame
6-month after the first training
Title
Barthel Index
Description
It assesses functional independence, generally in stroke patients.
Time Frame
6-month after the first training
Title
Berg Balance Scale
Description
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
Time Frame
6-month after the first training
Title
Modified Ashworth Scale
Description
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).
Time Frame
6-month after the first training
Title
Functional Ambulation Category Test
Description
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.
Time Frame
6-month after the first training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Kai-yu Tong, PhD
Phone
+85239438454
Email
kytong@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Kai-yu Tong, PhD
Organizational Affiliation
Department of Biomedical Engineering, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biomedical Engineering, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Tong, PhD
Phone
+852 3943 8454
Email
kytong@cuhk.edu.hk
12. IPD Sharing Statement
Learn more about this trial
AR Training Platform at Home
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