Parkinson DiseaseNCT04560504
Effectiveness of Oculomotor Training in Parkinson's Disease
A study testing Oculomotor Training Group in people with Parkinson Disease and Oculomotor; Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson Disease, Oculomotor; Disorder
- What is being tested?
- Oculomotor Training Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 Sep 2020to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Parkinson Disease, Oculomotor; Disorder
- Being tested
- Control Group, Oculomotor Training Group
- Keywords
- Parkinson Disease, Oculomotor deficit, Oculomotor training, Dynamic vision
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
Leisure activities
Oculomotor Training GroupOther
Eye movement training
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | 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 Receives: Other: Control Group |
| Intervention Group | Active comparator | 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 Receives: Other: Oculomotor Training Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline at week 4 and change from baseline at week 12
Secondary outcomes (3)
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')
Measured: Change from baseline at week 4 and change from baseline at week 12
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.
Measured: Change from baseline at week 4 and change from baseline at week 12
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.
Measured: Change from baseline at week 4 and change from baseline at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start3 Sep 2020
- Primary completion31 Aug 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Berkeley, Deakin University, Chinese University of Hong Kong, Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, Allen MY Cheong, The Hong Kong Polytechnic University
- Investigators
- Allen Ming Yan Cheong, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560504
- Sponsor's protocol ID
- 15102717
- Status last verified
- Oct 2024
- First submitted
- 7 Sep 2020
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04560504
- Acronym / sponsor ID
- 15102717
- Conditions
- Parkinson Disease, Oculomotor; Disorder
- Keywords
- Parkinson Disease, Oculomotor deficit, Oculomotor training, Dynamic vision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- University of California, Berkeley, Deakin University, Chinese University of Hong Kong, Hospital Authority, Hong Kong
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Control GroupReceive 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 |
| Intervention Group | Active comparator | Other: Oculomotor Training GroupReceive 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 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control GroupLeisure activities | Other | Control Group |
| Oculomotor Training GroupEye movement training | Other | Intervention Group |
Primary outcome
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
3 secondary outcomes
Oculomotor characteristics
Time frame: 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
Passage reading performance
Time frame: Change from baseline at week 4 and change from baseline at week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allen Ming Yan Cheong, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oculomotor Training Group in people with Parkinson Disease and Oculomotor; Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smooth Vergence eye movements (time frame: Change from baseline at week 4 and change from baseline at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.