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| Name | Class |
|---|---|
| University of Waterloo | OTHER |
| The University of Hong Kong | OTHER |
| University of Leicester | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Conventional physical training (PT) | Experimental | Participants in the PT will receive 45-minutes conventional physical training. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Action video game training | Behavioral | 20 sessions of AVG over 10 weeks (45 minutes per session, 2 sessions per week) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Static Balance Measure | Static Balance: Participants will be asked to stand on a force place with a foam while performing visual searching. Parameters including maximum antero-posterior amplitude (mm), maximum medio-lateral amplitude (mm), total sway path (mm), and root mean square sway (mm/s) will be analyzed. Each test would be repeated for 3 times. | Change from baseline at week 5 and change from baseline at week 10. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allen Cheong, PhD | Contact | 852-27666108 | allen.my.cheong@polyu.edu.hk | |
| Mable Tong, BSc | Contact | 852-92523992 | mable.mp.tong@polyu.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Allen Cheong, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Recruiting | Hong Kong | Hong Kong | 000000 | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40967649 | Derived | 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. |
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IPD that underlie results in a publication will be available upon reasonable request to the research team.
IPD will be available no later than 6 months following publication and for 1 year.
IPD will be shared with investigators who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
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| Conventional physical training | Behavioral | 20 sessions of physical training over 10 weeks (45 minutes per session, 2 sessions per week) |
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| Perturbed Balance Measure | Perturbed Balance: Participants will be asked to stand on a force place which will translate forward or backward while performing visual searching. Parameters including latency (ms) reacting to the perturbation, maximum antero-posterior amplitude (mm), maximum medio-lateral amplitude (mm), total sway path (mm), and root mean square sway (mm/s) will be analyzed. Each test would be repeated for 3 times. | Change from baseline at week 5 and change from baseline at week 10. |
| Useful field of view (UFOV) | Visual attention will be examined by Useful Field of View (UFOV). Participants will be asked to complete the following 3 tasks.
Parameter includes time to reach threshold(ms) | Change from baseline at week 5 and change from baseline at week 10. |
| Reaction time (RT) | Each participant is asked to complete the following task using a customized computer programme. Reaction Time Test: Participants will be asked to respond as fast as possible when the same stimulus (an 'x' emerging in a square in the middle of the screen) was presented. This test will be repeated for 3 blocks with 46 trials per block. Parameter includes reaction time to correct answer(ms). | Change from baseline at week 5 and change from baseline at week 10. |
| Cognitive Reflection Test | Each participant is asked to complete the following task using a customized computer programme. Cognitive Reflection Test: Participants will be presented with four squares horizontally on the screen. They will be asked to react to an 'x' emerging in one of the squares (40 trials in total) by pressing a corresponding key on a keyboard-'1', '2', '3', or '4' which present the position of 'x' . Parameter includes reaction time to correct answer(ms). | Change from baseline at week 5 and change from baseline at week 10. |
| Quality of Life Questionnaire measure | The effect of intervention on quality of life will be evaluated using the Learning Vector Quantization (LvQ) Scale. In the LvQ, participants will be asked to rate how much their eyesight has interfered with each of 24 activities in the past month. The completion results in a summed score between 0 (a low quality of life) and 125 (a high quality of life). | Change from baseline at week 5 and change from baseline at week 10. |
| Fear of Falling Questionnaire measure | The effect of intervention on fear of falling will be evaluated using the Chinese versions of Falls Efficacy Scale International (FES-I). In the FES-I, participants will be asked "how concerned they are about the possibility of falling" for each of the 16 social and physical activities. The completion results in a summed score between minimum 16 (no concern about falling) to maximum 64 (severe concern about falling). | Change from baseline at week 5 and change from baseline at week 10. |
| D009422 |
| Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |