Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE

ConditionsGlaucoma Visual Impairment

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age55-80

SponsorThe Hong Kong Polytechnic University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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;

Trial design

Design model

Factorial

Treatments tested in this trial

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

Treatment groups

56 Participants

are divided into 2 treatment groups

Group A: Interactive action video-game training (AVG)Active comparator 1 intervention

Group B: Conventional physical training (PT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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