Back to resultsEffectiveness of Oculomotor Training in Parkinson's Disease
Primary Purpose
Parkinson Disease, Oculomotor; Disorder
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Control Group
Oculomotor Training Group
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease focused on measuring Parkinson Disease, Oculomotor deficit, Oculomotor training, Dynamic vision
Eligibility Criteria
Inclusion Criteria:
Parkinson's Disease diagnosed by a neurologist or geriatrician with the range of Stage
1 to 4 (Hoehn and Yahr Classification)
- Able to speak and comprehend Cantonese dialect
- Able to travel independently
Exclusion Criteria:
- Any congenital eye problem (e.g. congenital strabismus or amblyopia in either eye) or any manifest eye diseases (e.g. macular degeneration, glaucoma, etc)
- Severe medical problems (e.g. stroke)
- Cognitive impairment (e.g. dementia)
- Presence of any psychiatric or neurological diseases (apart from Parkinson's disease) or receiving of any psychoactive pharmacological treatment
- Receiving any medication that is known to affect eye movement and cognitive function
- Previous formal vision rehabilitation or oculomotor intervention
Sites / Locations
- Allen MY Cheong
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control Group
Intervention Group
Arm Description
Receive 10 sessions of 45-minute (3 sessions per week) in-office leisure activities e.g. simple non-action computer games or board games (e.g. card and chess games) and 10-20 minutes of video watching at home
Receive 10 sessions of 45-minute office training (3 sessions per week) and 10-20 minute home training (3 sessions per week) of eye movement training
Outcomes
Primary Outcome Measures
Smooth Vergence eye movements
Smooth vergence eye movement is measured using a head-mounted eye tracking while fixating at an approaching target moving at different speeds
Secondary Outcome Measures
Oculomotor characteristics
With the use of eye tracking device, eye movement behavior of participants can be measured and analysed while performing the following tasks.
Fixation task - Fixate at stationary target presented on a monitor
Saccade task - Follow and fixate at a random jumping target presented on a monitor
Pursuit task - Follow accurately and steadily on a smooth moving target presented on a monitor
Jump Vergence task - Follow and fixate a jumping target presented in the anterior-posterior plane (jumping from 'far to near' or 'near to far')
Sentence reading performance
To evaluate the effectiveness of the interventions on sentence reading using MNREAD charts in Chinese. These charts developed in our laboratory are used to measure the effectiveness of sentence reading in terms of reading speed and critical print size.
Passage reading performance
To evaluate the effectiveness of the interventions on passage reading using International Reading speed Test (IReST). IReST is used to evaluate the effectiveness of passage reading performance by measuring the reading speed.
Full Information
NCT ID
NCT04560504
First Posted
September 7, 2020
Last Updated
September 19, 2022
Sponsor
The Hong Kong Polytechnic University
Collaborators
University of California, Berkeley, Deakin University, Chinese University of Hong Kong, Hospital Authority, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04560504
Brief Title
Effectiveness of Oculomotor Training in Parkinson's Disease
Official Title
Oculomotor Deficits in Parkinson's Disease: Enhancing Eye Movement Performance and Dynamic Visual Acuity With Oculomotor Training Using a Pilot Randomized Clinical Trial Design
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
University of California, Berkeley, Deakin University, Chinese University of Hong Kong, Hospital Authority, Hong Kong
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
Parkinson's disease (PD) is a common neurodegenerative disorder which is characterized by both motor and non-motor symptoms and usually affects people aged 50 years or above. Many studies showed eye movement deficits and visual changes in patients with PD.
Previous studies have also indicated that clinical eye movement training could enhance the functional performance of patients with various eye movement problems resulting from ocular and neurodegenerative diseases.
In this study, we will investigate the effectiveness of eye movement training on dynamic vision and functional performance in PD patients with oculomotor deficits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Oculomotor; Disorder
Keywords
Parkinson Disease, Oculomotor deficit, Oculomotor training, Dynamic vision
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Receive 10 sessions of 45-minute (3 sessions per week) in-office leisure activities e.g. simple non-action computer games or board games (e.g. card and chess games) and 10-20 minutes of video watching at home
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
Receive 10 sessions of 45-minute office training (3 sessions per week) and 10-20 minute home training (3 sessions per week) of eye movement training
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Leisure activities
Intervention Type
Other
Intervention Name(s)
Oculomotor Training Group
Intervention Description
Eye movement training
Primary Outcome Measure Information:
Title
Smooth Vergence eye movements
Description
Smooth vergence eye movement is measured using a head-mounted eye tracking while fixating at an approaching target moving at different speeds
Time Frame
Change from baseline at week 4 and change from baseline at week 12
Secondary Outcome Measure Information:
Title
Oculomotor characteristics
Description
With the use of eye tracking device, eye movement behavior of participants can be measured and analysed while performing the following tasks.
Fixation task - Fixate at stationary target presented on a monitor
Saccade task - Follow and fixate at a random jumping target presented on a monitor
Pursuit task - Follow accurately and steadily on a smooth moving target presented on a monitor
Jump Vergence task - Follow and fixate a jumping target presented in the anterior-posterior plane (jumping from 'far to near' or 'near to far')
Time Frame
Change from baseline at week 4 and change from baseline at week 12
Title
Sentence reading performance
Description
To evaluate the effectiveness of the interventions on sentence reading using MNREAD charts in Chinese. These charts developed in our laboratory are used to measure the effectiveness of sentence reading in terms of reading speed and critical print size.
Time Frame
Change from baseline at week 4 and change from baseline at week 12
Title
Passage reading performance
Description
To evaluate the effectiveness of the interventions on passage reading using International Reading speed Test (IReST). IReST is used to evaluate the effectiveness of passage reading performance by measuring the reading speed.
Time Frame
Change from baseline at week 4 and change from baseline at week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parkinson's Disease diagnosed by a neurologist or geriatrician with the range of Stage
1 to 4 (Hoehn and Yahr Classification)
Able to speak and comprehend Cantonese dialect
Able to travel independently
Exclusion Criteria:
Any congenital eye problem (e.g. congenital strabismus or amblyopia in either eye) or any manifest eye diseases (e.g. macular degeneration, glaucoma, etc)
Severe medical problems (e.g. stroke)
Cognitive impairment (e.g. dementia)
Presence of any psychiatric or neurological diseases (apart from Parkinson's disease) or receiving of any psychoactive pharmacological treatment
Receiving any medication that is known to affect eye movement and cognitive function
Previous formal vision rehabilitation or oculomotor intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Ming Yan Cheong, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allen MY Cheong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Oculomotor Training in Parkinson's Disease
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