Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE

Official title

The GRADE Randomized Trial: Glaucoma Rehabilitation With Action viDeo Games and Exercise

Overview

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.

Interventions

• Behavioral Action video game training
  20 sessions of AVG over 10 weeks (45 minutes per session, 2 sessions per week)
• Behavioral Conventional physical training
  20 sessions of physical training over 10 weeks (45 minutes per session, 2 sessions per week)

Primary outcome measures

• 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.]

Secondary outcome measures (7)

• 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.]

Eligibility criteria

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Single blind

Primary purpose

Other

Study locations

Hong Kong · 1 center

• The Hong Kong Polytechnic University — Hong Kong

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. PMID 40967649

Identifiers

NCT: NCT06000865 · 15602821

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗