Back to resultsGlaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE
Primary Purpose
Glaucoma, Visual Impairment
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Action video game training
Conventional physical training
Sponsored by
About this trial
This is an interventional other trial for Glaucoma focused on measuring Glaucoma, Peripheral field loss, Action video games, Balance functions, Fear of falling, Quality of life
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Interactive action video-game training (AVG)
Conventional physical training (PT)
Arm Description
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.
Participants in the PT will receive 45-minutes conventional physical training.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Processing speed: Participants will be asked to discriminate the central presented stimulus as a target or distractor.
Divided attention: In addition to discriminating the central target, participants are required to identify the location of the peripheral target.
Selective attention: Procedure is similar as "Divided attention". Participants are required to identify the location of peripheral target among the distractors.
Parameter includes time to reach threshold(ms)
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).
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).
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).
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).
Full Information
NCT ID
NCT06000865
First Posted
September 25, 2022
Last Updated
September 23, 2023
Sponsor
The Hong Kong Polytechnic University
Collaborators
University of Waterloo, The University of Hong Kong, University of Leicester
1. Study Identification
Unique Protocol Identification Number
NCT06000865
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 10, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
University of Waterloo, The University of Hong Kong, University of Leicester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Visual Impairment
Keywords
Glaucoma, Peripheral field loss, Action video games, Balance functions, Fear of falling, Quality of life
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interactive action video-game training (AVG)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conventional physical training (PT)
Arm Type
Experimental
Arm Description
Participants in the PT will receive 45-minutes conventional physical training.
Intervention Type
Behavioral
Intervention Name(s)
Action video game training
Intervention Description
20 sessions of AVG over 10 weeks (45 minutes per session, 2 sessions per week)
Intervention Type
Behavioral
Intervention Name(s)
Conventional physical training
Intervention Description
20 sessions of physical training over 10 weeks (45 minutes per session, 2 sessions per week)
Primary Outcome Measure Information:
Title
Gait Measure - Time Up and Go test combining Narrow path walking test
Description
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
Change from baseline at week 5 and change from baseline at week 10.
Secondary Outcome Measure Information:
Title
Static Balance Measure
Description
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.
Time Frame
Change from baseline at week 5 and change from baseline at week 10.
Title
Perturbed Balance Measure
Description
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.
Time Frame
Change from baseline at week 5 and change from baseline at week 10.
Title
Useful field of view (UFOV)
Description
Visual attention will be examined by Useful Field of View (UFOV). Participants will be asked to complete the following 3 tasks.
Processing speed: Participants will be asked to discriminate the central presented stimulus as a target or distractor.
Divided attention: In addition to discriminating the central target, participants are required to identify the location of the peripheral target.
Selective attention: Procedure is similar as "Divided attention". Participants are required to identify the location of peripheral target among the distractors.
Parameter includes time to reach threshold(ms)
Time Frame
Change from baseline at week 5 and change from baseline at week 10.
Title
Reaction time (RT)
Description
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).
Time Frame
Change from baseline at week 5 and change from baseline at week 10.
Title
Cognitive Reflection Test
Description
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).
Time Frame
Change from baseline at week 5 and change from baseline at week 10.
Title
Quality of Life Questionnaire measure
Description
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).
Time Frame
Change from baseline at week 5 and change from baseline at week 10.
Title
Fear of Falling Questionnaire measure
Description
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).
Time Frame
Change from baseline at week 5 and change from baseline at week 10.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allen Cheong, PhD
Phone
852-27666108
Email
allen.my.cheong@polyu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Mable Tong, BSc
Phone
852-92523992
Email
mable.mp.tong@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Cheong, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD that underlie results in a publication will be available upon reasonable request to the research team.
IPD Sharing Time Frame
IPD will be available no later than 6 months following publication and for 1 year.
IPD Sharing Access Criteria
IPD will be shared with investigators who provide a methodologically sound proposal.
Learn more about this trial
Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE
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