Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE

NCT ID: NCT06000865

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-09
• Study Completion Date: 2025-12-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Action video game training

Intervention Type: BEHAVIORAL

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

Conventional physical training (PT)

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

Group Type: EXPERIMENTAL

Conventional physical training

Intervention Type: BEHAVIORAL

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

Interventions

Action video game training

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

Intervention Type: BEHAVIORAL

Conventional physical training

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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 Montreal Cognitive Assessment - Hong Kong version (to confirm participants' intact cognitive function).

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Waterloo

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: collaborator

University of Leicester

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Allen MY Cheong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allen Cheong, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Allen Cheong, PhD

Role: CONTACT

allen.my.cheong@polyu.edu.hk

852-27666108

Mable Tong, BSc

Role: CONTACT

mable.mp.tong@polyu.edu.hk

852-92523992

References

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.

Reference Type: DERIVED

PMID: 40967649 (View on PubMed)

Other Identifiers

15602821

Identifier Type: -

Identifier Source: org_study_id