NCT04638218

Brief Summary

The Hong Kong Jockey Club Charities Trust has supported CUHK to launch a three-year project 'CUHK Jockey Club HOPE4Care Programme' to implement four evidence-based advanced rehabilitation technologies in 40 local elderly day care centres and rehabilitation centres, to benefit the community. Our research team had developed the "Augmented Reality (AR) Rehabilitation Training System" that can be used as tools for rehabilitation by individuals who have suffered from a stroke or elderly. The system facilitates an active rehabilitative exercise.

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
120

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2020

Typical duration 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 22, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

November 17, 2020

Last Update Submit

November 17, 2020

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • 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

    Three months after the last training session

Secondary Outcomes (7)

  • Modified Ashworth Scale

    Three months after the last training session

  • Functional Ambulation Category Test

    Three months after the last training session

  • Timed 10-meter Walk Test

    Three months after the last training session

  • 6 Minute Walk Test

    Three months after the last training session

  • Wolf Motor Function Test (WMFT)

    Three months after the last training session

  • +2 more secondary outcomes

Study Arms (1)

Augmented Reality

EXPERIMENTAL

The system provides visual and audio feedback which makes the rehabilitation training process more relaxing, interesting and convenient to guide the patients performing appropriate upper-limb, lower-limb exercises and balance training.

Device: Rehabilitation Training System

Interventions

Rehabilitation Training SystemDEVICE

The system can capture useful biomechanical data accurately, such as the location of body centre of mass (COM), the body joint angles, and the body posture. These useful data are stored in a database and can be conveniently accessed by the therapists, which facilitate the follow-up of the patients' therapeutic progress.

Augmented Reality

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of ischemic brain injury or intracerebral haemorrhage shown by magnetic resonance imaging or computed tomography after the onset of stroke;
  • Motor impairment in upper-limb, lower-limb, and/or balance;
  • No or mild spasticity on the lower-limb or upper-limb (MAS≤2);
  • Have sufficient cognition to follow the instructions provided by the rehab system.

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

Shatin, Hong Kong

RECRUITING

Related Publications (1)

  • Yang ZQ, Du D, Wei XY, Tong RK. Augmented reality for stroke rehabilitation during COVID-19. J Neuroeng Rehabil. 2022 Dec 8;19(1):136. doi: 10.1186/s12984-022-01100-9.

    PMID: 36482468DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Raymond Tong, PhD

    Department of Biomedical Engineering, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Tong, PhD

CONTACT

+852 3943 8454kytong@cuhk.edu.hk

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 17, 2020

First Posted

November 20, 2020

Study Start

January 22, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

November 20, 2020

Record last verified: 2020-11

Locations

HK(1)