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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05627050
Other study ID # 2020.538
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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