AR Training Platform at Home

Stroke Clinical Trial

Official title:

Online AR Training Platform for the Elderly and Persons With Chronic Diseases at Home

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05627050
• Other study ID #: 2020.538
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: December 2024

Study information

• Verified date: November 2022
• Source: Chinese University of Hong Kong
• Contact: Raymond Kai-yu Tong, PhD
• Phone: +85239438454
• Email: kytong[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age >=65 years old or suffering from chronic disease;

2. sufficient cognition to follow simple instructions as well as understand the content and purpose of the study MoCA> 21); and

3. Home setting: TV with HDMI input, internet access, and a distance of 1.5m away from TV.

Exclusion Criteria:

1. 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;

2. Severe shoulder or arm contracture/pain;

3. Severe knee or hip contracture/pain;

4. Pregnant women

Related Conditions & MeSH terms

• Chronic Disease
• Stroke

Intervention

Device:
• An Online Augmented Reality (AR) Training Platform
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.

Locations

Country	Name	City	State
Hong Kong	Department of Biomedical Engineering, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6-month after the first training
Secondary	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.	6-month after the first training
Secondary	Barthel Index	It assesses functional independence, generally in stroke patients.	6-month after the first training
Secondary	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	6-month after the first training
Secondary	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).	6-month after the first training
Secondary	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.	6-month after the first training