NCT04560504

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

September 7, 2020

Last Update Submit

October 28, 2024

Conditions

Parkinson DiseaseOculomotor; Disorder

Keywords

Parkinson DiseaseOculomotor deficitOculomotor trainingDynamic vision

Outcome Measures

Primary Outcomes (1)

  • 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

    Change from baseline at week 4 and change from baseline at week 12

Secondary Outcomes (3)

  • Oculomotor characteristics

    Change from baseline at week 4 and change from baseline at week 12

  • Sentence reading performance

    Change from baseline at week 4 and change from baseline at week 12

  • Passage reading performance

    Change from baseline at week 4 and change from baseline at week 12

Study Arms (2)

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

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

Other: Oculomotor Training Group

Interventions

Control GroupOTHER

Leisure activities

Control Group
Oculomotor Training GroupOTHER

Eye movement training

Intervention Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson's Disease diagnosed by a neurologist or geriatrician with the range of Stage
  • to 4 (Hoehn and Yahr Classification)
  • Able to speak and comprehend Cantonese dialect
  • Able to travel independently

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allen MY Cheong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Allen Ming Yan Cheong, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 23, 2020

Study Start

September 3, 2020

Primary Completion

August 31, 2022

Study Completion

December 1, 2022

Last Updated

October 29, 2024

Record last verified: 2024-10

Locations

HK(1)