GlaucomaNCT06000865
Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE
A study testing Action video game training and Conventional physical training in people with Glaucoma and Visual Impairment, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Falls are one of the most serious public health concerns for seniors, with significant medical and economic consequences. This concern is even higher in patients with peripheral field loss due to glaucoma because of the patients' compromised visual input. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Glaucoma, Visual Impairment
- What is being tested?
- Action video game training and Conventional physical training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteHong Kong
- Study dates
- 9 Sep 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of moderate to severe bilateral glaucomatous optic neuropathy (GON) from primary open-angle (including normal tension) or angle-closure glaucoma, as determined by an ophthalmologist, with abnormal Glaucoma Hemifield Test on standard Humphrey Field Analyzer 24-2 testing and matching nerve-fiber layer thinning on optical coherence tomography;
- Stable vision and visual field loss for at least 3 months;
- With a best-corrected distance acuity of 6/12 or better (equivalent to 0.3 logMAR acuity or better to confirm that participant's central vision is preserved);
- With a cognitive functional score of 22 or above in the Montreal Cognitive Assessment - Hong Kong version (to confirm participants' intact cognitive function).
Who cannot join
- Advanced glaucoma with GON of median deviation worse than -25 decibel;
- Ocular diseases other than glaucoma (e.g., age-related macular degeneration, diabetic retinopathy, and moderate to severe cataract);
- Severe medical problems (e.g., stroke, Parkinson's disease) or self-reported neurological (e.g. brain surgery, brain tumor and peripheral neuropathy), or cognitive disorders (e.g., diagnosed dementia or cognitive impairment);
- Physical impairments (e.g. need the use of orthopedic and mobility aids) or physical limitations restricting them from independent walking;
- Self-reported or medically diagnosed vestibular/ cerebellar dysfunction, history of vertigo, or severe hearing loss;
- Using any medications for any neurological conditions or psychiatric drugs (e.g. sedative, hypnotic) that might interfere motor control; and
- Currently attending any intensive physical/balance training.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong, Hong Kong, 000000
About this study
Official title: The GRADE Randomized Trial: Glaucoma Rehabilitation With Action viDeo Games and Exercise
Falls are one of the most serious public health concerns for seniors, with significant medical and economic consequences. This concern is even higher in patients with peripheral field loss due to glaucoma because of the patients' compromised visual input. The investigators' project proposes an innovative, entertaining, easily accessible and enjoyable intervention for improving mobility and postural control function in glaucoma patients with peripheral vision loss, who are more prone to falls and suffer from fear of falling. The new intervention examined in this project can be implemented in current vision and balance rehabilitation programs, and may benefit patients with different types of visual impairment to minimize their risk of falls and improve their quality of life.
Read the detailed description
A prospective, 2-arm, randomized, single-blind, active-control trial will enroll 56 moderately- to severely-affected glaucoma patients with stable peripheral field loss, intact cognitive function, and no history of balance training. Participants will be randomly assigned 1:1 to one of two groups: 1) standing, physically interactive action video-game training (AVG_PI); and 2) conventional physical training (PT). AVG using a Nintendo Switch gaming station will be administered in 20 sessions over 10 weeks (45 minutes per session, 2 sessions per week). Participants in the AVG_PI will be in standing position with game controllers or sensors attached to the body while playing games involving muscle stretching and strengthening exercises. Participants in the PT will receive 45-minutes conventional physical training. Outcome measures will be assessed before training, and after 10 and 20 training sessions. The primary outcome measure is a test of mobility, and the secondary outcome measures include tests for dynamic balance plus visual cognition, static balance, visual cognition, and patient reported outcomes for fear of falling and quality of life.
- Conditions
- Glaucoma, Visual Impairment
- Being tested
- Action video game training, Conventional physical training
- Keywords
- Glaucoma, Peripheral field loss, Action video games, Balance functions, Fear of falling, Quality of life
- Medical subject headings
- Glaucoma, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action video game trainingBehavioural
20 sessions of AVG over 10 weeks (45 minutes per session, 2 sessions per week)
Conventional physical trainingBehavioural
20 sessions of physical training over 10 weeks (45 minutes per session, 2 sessions per week)
| Study group | Role | What they receive |
|---|---|---|
| Interactive action video-game training (AVG) | Active comparator | AVG using a Nintendo Switch gaming station will be administered in 20 sessions over 10 weeks (45 minutes per session, 2 sessions per week). Participants will be in standing position with game controllers or sensors attached to the body while playing games involving muscle stretching and strengthening exercises. Receives: Behavioral: Action video game training |
| Conventional physical training (PT) | Experimental | Participants in the PT will receive 45-minutes conventional physical training. Receives: Behavioral: Conventional physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Measure - Time Up and Go test combining Narrow path walking test
Time Up and Go test combining Narrow path walking test: All participants need to stand up from a 46 cm height chair, walk on the path at their usual pace until the strip of a non-reflective tape, cross over the tape, turn 180°, walk to the starting position and finally sit down. Then repeat the same procedure within a narrower width. Participants need to use the dominant leg to step onto the standing position on one force plate while the non-dominant leg stands on the other force plate.
The test will repeat for 10 times. Participants' gait parameters including hip flexion/extension (degree), knee Min/Max (degree), ankle flexion/extension (degree), walking speed (mm/s), step width (mm), and step length(mm) will be measured and analyzed for each condition.
Measured: Change from baseline at week 5 and change from baseline at week 10.
Secondary outcomes (7)
Static Balance Measure
Static Balance: Participants will be asked to stand on a force place with a foam while performing visual searching. Parameters including maximum antero-posterior amplitude (mm), maximum medio-lateral amplitude (mm), total sway path (mm), and root mean square sway (mm/s) will be analyzed.
Each test would be repeated for 3 times.
Measured: Change from baseline at week 5 and change from baseline at week 10.
Perturbed Balance Measure
Perturbed Balance: Participants will be asked to stand on a force place which will translate forward or backward while performing visual searching. Parameters including latency (ms) reacting to the perturbation, maximum antero-posterior amplitude (mm), maximum medio-lateral amplitude (mm), total sway path (mm), and root mean square sway (mm/s) will be analyzed.
Each test would be repeated for 3 times.
Measured: Change from baseline at week 5 and change from baseline at week 10.
Useful field of view (UFOV)
Visual attention will be examined by Useful Field of View (UFOV). Participants will be asked to complete the following 3 tasks.
- Processing speed: Participants will be asked to discriminate the central presented stimulus as a target or distractor.
- Divided attention: In addition to discriminating the central target, participants are required to identify the location of the peripheral target.
- Selective attention: Procedure is similar as "Divided attention". Participants are required to identify the location of peripheral target among the distractors.
Parameter includes time to reach threshold(ms)
Measured: Change from baseline at week 5 and change from baseline at week 10.
Reaction time (RT)
Each participant is asked to complete the following task using a customized computer programme.
Reaction Time Test: Participants will be asked to respond as fast as possible when the same stimulus (an 'x' emerging in a square in the middle of the screen) was presented.
This test will be repeated for 3 blocks with 46 trials per block. Parameter includes reaction time to correct answer(ms).
Measured: Change from baseline at week 5 and change from baseline at week 10.
Cognitive Reflection Test
Each participant is asked to complete the following task using a customized computer programme.
Cognitive Reflection Test: Participants will be presented with four squares horizontally on the screen. They will be asked to react to an 'x' emerging in one of the squares (40 trials in total) by pressing a corresponding key on a keyboard-'1', '2', '3', or '4' which present the position of 'x' . Parameter includes reaction time to correct answer(ms).
Measured: Change from baseline at week 5 and change from baseline at week 10.
Quality of Life Questionnaire measure
The effect of intervention on quality of life will be evaluated using the Learning Vector Quantization (LvQ) Scale.
In the LvQ, participants will be asked to rate how much their eyesight has interfered with each of 24 activities in the past month. The completion results in a summed score between 0 (a low quality of life) and 125 (a high quality of life).
Measured: Change from baseline at week 5 and change from baseline at week 10.
Fear of Falling Questionnaire measure
The effect of intervention on fear of falling will be evaluated using the Chinese versions of Falls Efficacy Scale International (FES-I).
In the FES-I, participants will be asked "how concerned they are about the possibility of falling" for each of the 16 social and physical activities. The completion results in a summed score between minimum 16 (no concern about falling) to maximum 64 (severe concern about falling).
Measured: Change from baseline at week 5 and change from baseline at week 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start9 Sep 2023
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Waterloo, The University of Hong Kong, University of Leicester
- Responsible party
- Principal investigator, Allen MY Cheong, The Hong Kong Polytechnic University
- Investigators
- Allen Cheong, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000865
- Sponsor's protocol ID
- 15602821
- Status last verified
- Mar 2025
- First submitted
- 25 Sep 2022
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie results in a publication will be available upon reasonable request to the research team.
Publications
Yihong P, Thompson B, Winser S, Lau I, Suen V, Cheung M, Cheong AMY. Glaucoma rehabilitation with action video games and exercise: study protocol of an active-controlled trial (GRADE). BMJ Open. 2025 Sep 17;15(9):e105971. doi: 10.1136/bmjopen-2025-105971.
PubMed 40967649
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GRADE Randomized Trial: Glaucoma Rehabilitation With Action viDeo Games and Exercise
- ClinicalTrials.gov ID
- NCT06000865
- Acronym / sponsor ID
- 15602821
- Conditions
- Glaucoma, Visual Impairment
- Keywords
- Glaucoma, Peripheral field loss, Action video games, Balance functions, Fear of falling, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- University of Waterloo, The University of Hong Kong, University of Leicester
- Study start
- 9 Sep 2023 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 21 Aug 2023 (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.
Falls are one of the most serious public health concerns for seniors, with significant medical and economic consequences. This concern is even higher in patients with peripheral field loss due to glaucoma because of the patients' compromised visual input. The investigators' project proposes an innovative, entertaining, easily accessible and enjoyable intervention for improving mobility and postural control function in glaucoma patients with peripheral vision loss, who are more prone to falls and suffer from fear of falling. The new intervention examined in this project can be implemented in current vision and balance rehabilitation programs, and may benefit patients with different types of visual impairment to minimize their risk of falls and improve their quality of life.
Detailed description
A prospective, 2-arm, randomized, single-blind, active-control trial will enroll 56 moderately- to severely-affected glaucoma patients with stable peripheral field loss, intact cognitive function, and no history of balance training. Participants will be randomly assigned 1:1 to one of two groups: 1) standing, physically interactive action video-game training (AVG_PI); and 2) conventional physical training (PT). AVG using a Nintendo Switch gaming station will be administered in 20 sessions over 10 weeks (45 minutes per session, 2 sessions per week). Participants in the AVG_PI will be in standing position with game controllers or sensors attached to the body while playing games involving muscle stretching and strengthening exercises. Participants in the PT will receive 45-minutes conventional physical training. Outcome measures will be assessed before training, and after 10 and 20 training sessions. The primary outcome measure is a test of mobility, and the secondary outcome measures include tests for dynamic balance plus visual cognition, static balance, visual cognition, and patient reported outcomes for fear of falling and quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive action video-game training (AVG) | Active comparator | Behavioral: Action video game trainingAVG using a Nintendo Switch gaming station will be administered in 20 sessions over 10 weeks (45 minutes per session, 2 sessions per week). Participants will be in standing position with game controllers or sensors attached to the body while playing games involving muscle stretching and strengthening exercises. |
| Conventional physical training (PT) | Experimental | Behavioral: Conventional physical trainingParticipants in the PT will receive 45-minutes conventional physical training. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of moderate to severe bilateral glaucomatous optic neuropathy (GON) from primary open-angle (including normal tension) or angle-closure glaucoma, as determined by an ophthalmologist, with abnormal Glaucoma Hemifield Test on standard Humphrey Field Analyzer 24-2 testing and matching nerve-fiber layer thinning on optical coherence tomography;
- Stable vision and visual field loss for at least 3 months;
- With a best-corrected distance acuity of 6/12 or better (equivalent to 0.3 logMAR acuity or better to confirm that participant's central vision is preserved);
- With a cognitive functional score of 22 or above in the Montreal Cognitive Assessment - Hong Kong version (to confirm participants' intact cognitive function).
Key exclusion criteria (7 listed)
- Advanced glaucoma with GON of median deviation worse than -25 decibel;
- Ocular diseases other than glaucoma (e.g., age-related macular degeneration, diabetic retinopathy, and moderate to severe cataract);
- Severe medical problems (e.g., stroke, Parkinson's disease) or self-reported neurological (e.g. brain surgery, brain tumor and peripheral neuropathy), or cognitive disorders (e.g., diagnosed dementia or cognitive impairment);
- Physical impairments (e.g. need the use of orthopedic and mobility aids) or physical limitations restricting them from independent walking;
- Self-reported or medically diagnosed vestibular/ cerebellar dysfunction, history of vertigo, or severe hearing loss;
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 |
|---|---|---|
| Action video game training20 sessions of AVG over 10 weeks (45 minutes per session, 2 sessions per week) | Behavioural | Interactive action video-game training (AVG) |
| Conventional physical training20 sessions of physical training over 10 weeks (45 minutes per session, 2 sessions per week) | Behavioural | Conventional physical training (PT) |
Primary outcome
Gait Measure - Time Up and Go test combining Narrow path walking test
Time frame: Change from baseline at week 5 and change from baseline at week 10.
Time Up and Go test combining Narrow path walking test: All participants need to stand up from a 46 cm height chair, walk on the path at their usual pace until the strip of a non-reflective tape, cross over the tape, turn 180°, walk to the starting position and finally sit down. Then repeat the same procedure within a narrower width. Participants need to use the dominant leg to step onto the standing position on one force plate while the non-dominant leg stands on the other force plate. The test will repeat for 10 times. Participants' gait parameters including hip flexion/extension (degree), knee Min/Max (degree), ankle flexion/extension (degree), walking speed (mm/s), step width (mm), and step length(mm) will be measured and analyzed for each condition.
7 secondary outcomes
Static Balance Measure
Time frame: Change from baseline at week 5 and change from baseline at week 10.
Perturbed Balance Measure
Time frame: Change from baseline at week 5 and change from baseline at week 10.
Useful field of view (UFOV)
Time frame: Change from baseline at week 5 and change from baseline at week 10.
Reaction time (RT)
Time frame: Change from baseline at week 5 and change from baseline at week 10.
Cognitive Reflection Test
Time frame: Change from baseline at week 5 and change from baseline at week 10.
Quality of Life Questionnaire measure
Time frame: Change from baseline at week 5 and change from baseline at week 10.
Fear of Falling Questionnaire measure
Time frame: Change from baseline at week 5 and change from baseline at week 10.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Derived from this study: PubMed 40967649Yihong P, Thompson B, Winser S, Lau I, Suen V, Cheung M, Cheong AMY. Glaucoma rehabilitation with action video games and exercise: study protocol of an active-controlled trial (GRADE). BMJ Open. 2025 Sep 17;15(9):e105971. doi: 10.1136/bmjopen-2025-105971.
- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication will be available upon reasonable request to the research team.
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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.
Allen Cheong, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action video game training and Conventional physical training in people with Glaucoma and Visual Impairment, run by The Hong Kong Polytechnic University 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 28 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allen Cheong, PhD (852-27666108, allen.my.cheong@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Measure - Time Up and Go test combining Narrow path walking test (time frame: Change from baseline at week 5 and change from baseline at week 10.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06000865, which also lists 1 linked publication.
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 28 Jul 2025.