StrokeNCT05627050
AR Training Platform at Home
A study testing An Online Augmented Reality (AR) Training Platform in people with Stroke and Chronic Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Chronic Disease
- What is being tested?
- An Online Augmented Reality (AR) Training Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteHong Kong
- Study dates
- 13 Jan 2021to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Biomedical Engineering, The Chinese University of Hong Kong
Hong Kong
Raymond Tong, PhD, +852 3943 8454, kytong@cuhk.edu.hk
About this study
Official title: Online AR Training Platform for the Elderly and Persons With Chronic Diseases at Home
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.
- Conditions
- Stroke, Chronic Disease
- Being tested
- An Online Augmented Reality (AR) Training Platform
- Medical subject headings
- Stroke, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An Online Augmented Reality (AR) Training PlatformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: An Online Augmented Reality (AR) Training Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6-month after the first training
Secondary outcomes (5)
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.
Measured: 6-month after the first training
Barthel Index
It assesses functional independence, generally in stroke patients.
Measured: 6-month after the first training
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
Measured: 6-month after the first training
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).
Measured: 6-month after the first training
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.
Measured: 6-month after the first training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start13 Jan 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond KY Tong, Chinese University of Hong Kong
- Investigators
- Raymond Kai-yu Tong, PhD, Principal investigator, Department of Biomedical Engineering, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627050
- Sponsor's protocol ID
- 2020.538
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2022
- Last updated
- 25 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online AR Training Platform for the Elderly and Persons With Chronic Diseases at Home
- ClinicalTrials.gov ID
- NCT05627050
- Acronym / sponsor ID
- 2020.538
- Conditions
- Stroke, Chronic Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AR Training System | Experimental | Device: An Online Augmented Reality (AR) Training PlatformThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An Online Augmented Reality (AR) Training PlatformThe 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. | Device | AR Training System |
Primary outcome
Fugl-Meyer Assessment
Time frame: 6-month after the first training
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).
5 secondary outcomes
The 12-item Short Form Survey
Time frame: 6-month after the first training
Barthel Index
Time frame: 6-month after the first training
Berg Balance Scale
Time frame: 6-month after the first training
Modified Ashworth Scale
Time frame: 6-month after the first training
Functional Ambulation Category Test
Time frame: 6-month after the first training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Kai-yu Tong, PhD principal investigator
Department of Biomedical Engineering, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An Online Augmented Reality (AR) Training Platform in people with Stroke and Chronic Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raymond Kai-yu Tong, PhD (+85239438454, kytong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (time frame: 6-month after the first training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2022.