NCT05627050

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 25, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 25, 2022

Status Verified

November 1, 2022

Enrollment Period

3.9 years

First QC Date

November 16, 2022

Last Update Submit

November 16, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • The 12-item Short Form Survey

    6-month after the first training

  • Barthel Index

    6-month after the first training

  • Berg Balance Scale

    6-month after the first training

  • Modified Ashworth Scale

    6-month after the first training

  • Functional Ambulation Category Test

    6-month after the first training

Study Arms (1)

AR Training System

EXPERIMENTAL

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.

Device: An Online Augmented Reality (AR) Training Platform

Interventions

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.

AR Training System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

StrokeChronic Disease

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Raymond Kai-yu Tong, PhD

    Department of Biomedical Engineering, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Kai-yu Tong, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chairman

Study Record Dates

First Submitted

November 16, 2022

First Posted

November 25, 2022

Study Start

January 13, 2021

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

November 25, 2022

Record last verified: 2022-11

Locations