ClinicalTrials.gg
RecruitingNCT06000865Updated Jul 28, 2025

Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE

An interventional study of Action video game training and Conventional physical training in Glaucoma and Visual Impairment, sponsored by The Hong Kong Polytechnic University. Recruiting at 1 site in Hong Kong. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-28.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
55 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Glaucoma
  • Visual Impairment

Keywords

  • Glaucoma
  • Peripheral field loss
  • Action video games
  • Balance functions
  • Fear of falling
  • Quality of life
03

In context

Glaucoma

1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.

This study's planned enrollment of 56 is close to the median of 61 across 964 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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;
  2. Stable vision and visual field loss for at least 3 months;
  3. 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);
  4. With a cognitive functional score of 22 or above in the - Hong Kong version (to confirm participants' intact cognitive function).

Exclusion criteria

Exclusion Criteria:

  1. Advanced glaucoma with GON of median deviation worse than -25 decibel;
  2. Ocular diseases other than glaucoma (e.g., age-related macular degeneration, diabetic retinopathy, and moderate to severe cataract);
  3. 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);
  4. Physical impairments (e.g. need the use of orthopedic and mobility aids) or physical limitations restricting them from independent walking;
  5. Self-reported or medically diagnosed vestibular/ cerebellar dysfunction, history of vertigo, or severe hearing loss;
  6. Using any medications for any neurological conditions or psychiatric drugs (e.g. sedative, hypnotic) that might interfere motor control; and
  7. Currently attending any intensive physical/balance training.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
56 participants (estimated)

Study arms

  • Active comparator
    Interactive action video-game training (AVG)

    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.

    Behavioral: Action video game training

  • Experimental
    Conventional physical training (PT)

    Participants in the PT will receive 45-minutes conventional physical training.

    Behavioral: Conventional physical training

Interventions

  • BehavioralAction video game training

    20 sessions of AVG over 10 weeks (45 minutes per session, 2 sessions per week)

  • BehavioralConventional physical training

    20 sessions of physical training over 10 weeks (45 minutes per session, 2 sessions per week)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline at week 5 and change from baseline at week 10.

Secondary outcomes

  1. 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.

    Time frame: Change from baseline at week 5 and change from baseline at week 10.

  2. 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.

    Time frame: Change from baseline at week 5 and change from baseline at week 10.

  3. 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. 1. Processing speed: Participants will be asked to discriminate the central presented stimulus as a target or distractor. 2. Divided attention: In addition to discriminating the central target, participants are required to identify the location of the peripheral target. 3. 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)

    Time frame: Change from baseline at week 5 and change from baseline at week 10.

  4. 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).

    Time frame: Change from baseline at week 5 and change from baseline at week 10.

  5. 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).

    Time frame: Change from baseline at week 5 and change from baseline at week 10.

  6. 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).

    Time frame: Change from baseline at week 5 and change from baseline at week 10.

  7. 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).

    Time frame: Change from baseline at week 5 and change from baseline at week 10.

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes — IPD that underlie results in a publication will be available upon reasonable request to the research team.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: IPD will be available no later than 6 months following publication and for 1 year.

Access criteria: IPD will be shared with investigators who provide a methodologically sound proposal.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06000865
Collaborators
University of Waterloo, The University of Hong Kong, University of Leicester
Responsible party
Allen MY Cheong (Professor, The Hong Kong Polytechnic University) — Principal investigator
First posted
Aug 21, 2023
Start date
Sep 9, 2023
Primary completion
Jul 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Jul 28, 2025

Study contacts

Allen Cheong, PhD
Contact
allen.my.cheong@polyu.edu.hk
852-27666108
Mable Tong, BSc
Contact
mable.mp.tong@polyu.edu.hk
852-92523992
Allen Cheong, PhD
principal investigator · The Hong Kong Polytechnic University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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