- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04560504
Effectiveness of Oculomotor Training in Parkinson's Disease
Oculomotor Deficits in Parkinson's Disease: Enhancing Eye Movement Performance and Dynamic Visual Acuity With Oculomotor Training Using a Pilot Randomized Clinical Trial Design
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Allen MY Cheong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control Group
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
|
Leisure activities
|
Active Comparator: Intervention Group
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
|
Eye movement training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smooth Vergence eye movements
Time Frame: Change from baseline at week 4 and change from baseline at week 12
|
Smooth vergence eye movement is measured using a head-mounted eye tracking while fixating at an approaching target moving at different speeds
|
Change from baseline at week 4 and change from baseline at week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oculomotor characteristics
Time Frame: Change from baseline at week 4 and change from baseline at week 12
|
With the use of eye tracking device, eye movement behavior of participants can be measured and analysed while performing the following tasks.
|
Change from baseline at week 4 and change from baseline at week 12
|
Sentence reading performance
Time Frame: Change from baseline at week 4 and change from baseline at week 12
|
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.
|
Change from baseline at week 4 and change from baseline at week 12
|
Passage reading performance
Time Frame: Change from baseline at week 4 and change from baseline at week 12
|
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.
|
Change from baseline at week 4 and change from baseline at week 12
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Allen Ming Yan Cheong, PhD, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15102717
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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