Clinical trial NCT06000865: Glaucoma Rehabilitation with Action ViDeo Games and Exercise - GRADE
Official title: The GRADE Randomized Trial: Glaucoma Rehabilitation with Action ViDeo Games and Exercise
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Visual Impairment
Keywords: Glaucoma
Peripheral field loss
Action video games
Balance functions
Fear of falling
Quality of life
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: University of Waterloo
name: The University of Hong Kong
name: University of Leicester
First posted: 2023-08-21
Enrollment: 56
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Gait Measure - Time Up and Go test combining Narrow path walking test
timeFrame: Change from baseline at week 5 and change from baseline at week 10.
Secondary outcomes:
measure: Static Balance Measure
timeFrame: Change from baseline at week 5 and change from baseline at week 10.
measure: Perturbed Balance Measure
timeFrame: Change from baseline at week 5 and change from baseline at week 10.
measure: Useful field of view (UFOV)
timeFrame: Change from baseline at week 5 and change from baseline at week 10.
measure: Reaction time (RT)
timeFrame: Change from baseline at week 5 and change from baseline at week 10.
measure: Cognitive Reflection Test
timeFrame: Change from baseline at week 5 and change from baseline at week 10.
measure: Quality of Life Questionnaire measure
timeFrame: Change from baseline at week 5 and change from baseline at week 10.
measure: Fear of Falling Questionnaire measure
timeFrame: Change from baseline at week 5 and change from baseline at week 10.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Allen Cheong, PhD
role: PRINCIPAL_INVESTIGATOR
References: