Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE

NCT06000865 | Recruiting

• 1 other identifier: 15602821
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Visual Impairment

Keywords

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

Outcome Measures

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.

  Change from baseline at week 5 and change from baseline at week 10.

Secondary Outcomes (7)

• Static Balance Measure

  Change from baseline at week 5 and change from baseline at week 10.

• Perturbed Balance Measure

  Change from baseline at week 5 and change from baseline at week 10.

• Useful field of view (UFOV)

  Change from baseline at week 5 and change from baseline at week 10.

• Reaction time (RT)

  Change from baseline at week 5 and change from baseline at week 10.

• Cognitive Reflection Test

  Change from baseline at week 5 and change from baseline at week 10.

Study Arms (2)

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.

Behavioral: Action video game training

Conventional physical training (PT)

EXPERIMENTAL

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

Behavioral: Conventional physical training

Interventions

Action video game training BEHAVIORAL

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

Interactive action video-game training (AVG)

Conventional physical training BEHAVIORAL

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

Conventional physical training (PT)

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• University of Waterloo: collaborator
• The University of Hong Kong: collaborator
• University of Leicester: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, 000000, Hong Kong

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Glaucoma; Vision Disorders

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Allen Cheong, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allen Cheong, PhD

CONTACT

852-27666108; allen.my.cheong@polyu.edu.hk

Mable Tong, BSc

CONTACT

852-92523992; mable.mp.tong@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: August 21, 2023
• Study Start: September 9, 2023
• Primary Completion: July 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

HK (1)