NCT07525973

Brief Summary

The objective of the trial is to assess key areas of uncertainty regarding the use of synchronous home-based tele eye exercises in future practice and research for patients with Parkinson's disease (PD), including issues relating to feasibility, safety, and potential for efficacy on motor performance, balance, and fall risk.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
4mo left

Started May 2026

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress5%
May 2026Sep 2026

First Submitted

Initial submission to the registry

April 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 6, 2026

Last Update Submit

April 6, 2026

Conditions

Keywords

Parkinson diseaseEye exercisesOculomotor trainingVisual exercisesBalanceFall riskMotor performanceTele-exerciseHome-based exercise

Outcome Measures

Primary Outcomes (2)

  • Change in balance

    Balance will be assessed from baseline to week 8 using a standardized clinical balance measure such as the Berg Balance Scale and/or the Mini-BESTest. Recent Parkinson's disease exercise syntheses have used BBS, MiniBESTest, and TUG as core balance and mobility outcomes, and a 2024 eye-movement training trial in Parkinson's disease used BBS and FSST to capture balance-related change.

    Baseline and Week 8

  • Change in functional mobility and fall risk

    Functional mobility and fall risk will be assessed from baseline to week 8 using the Timed Up and Go test, with falls-related self-efficacy and actual falls recorded if feasible. Recent Parkinson's disease studies and reviews identify TUG, falls, and near-falls as relevant measures of mobility and fall risk.

    Baseline and Week 8

Secondary Outcomes (2)

  • Change in walking capacity

    Baseline and Week 8

  • Change in eye-movement performance

    Baseline and Week 8

Study Arms (2)

Eye Exercise group

EXPERIMENTAL

The participants in the study group will be given an online personalized eye exercise program at home. Each session will be 30 to 45 min in duration for 3 days per week over 8 weeks, 24 sessions in total.

Behavioral: Home based Eye Exercises

Control group

NO INTERVENTION

Patients allocated to the control group will receive their standard neurological care. Through the 8-week period, all control participants will be instructed to maintain the standard treatment regimen and to maintain their customary dietary and physical activity patterns.

Interventions

The participants in the study group will be given an online personalized eye exercise program at home. Synchronous tele-exercise will be delivered using the free teleconference application (app) (Google Meets software). The groups of tele-exercises will be private and the professional will send the link for each training session and will control the access of the participants. Each session will be 30 to 45 min in duration for 3 days per week over 8 weeks, 24 sessions in total. The program includes progressive oculomotor exercises such as horizontal/vertical saccades to targets, smooth pursuit tracking, vergence (near-far focus shifts), fixation stability, and combined eye-head movements, with progression in speed, amplitude, and complexity.

Eye Exercise group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years and over
  • Clinically diagnosed idiopathic Parkinson's disease (Hoehn and Yahr stages 1-3)
  • Stable antiparkinsonian medication regimen for at least 1 month
  • Able to walk independently or with minimal assistance (cane/walker allowed)
  • Permission from their neurologist
  • Have decision-making capacity to enable them to give informed consent to take part in the study
  • Have access to a smart device (e.g., smartphone, laptop, or tablet) and internet access

You may not qualify if:

  • Unstable cardiac status (angina, decompensated congestive heart failure, severe arrhythmias, etc.)
  • Active infection or acute medical illness
  • Hemodynamic instability
  • Severe cognitive impairment (Mini-Mental State Examination \< 24)
  • Unable to exercise (lower extremity amputation without prosthesis or severe musculoskeletal pain at rest/minimal activity)
  • Recent fall resulting in fracture or hospitalization (within 3 months)
  • Unstable PD treatment or changing (titrating) medication regime
  • Myocardial infarction or stroke within past 3 months
  • Severe visual impairment not correctable with glasses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pardis specialized wellness institute

Isfahan, Isfahan, Iran

Location

Related Publications (12)

  • Zhu J, Cui Y, Zhang J, Yan R, Su D, Zhao D, Wang A, Feng T. Temporal trends in the prevalence of Parkinson's disease from 1980 to 2023: a systematic review and meta-analysis. Lancet Healthy Longev. 2024 Jul;5(7):e464-e479. doi: 10.1016/S2666-7568(24)00094-1.

    PMID: 38945129BACKGROUND
  • Niering M, Wirth C, Beurskens R, Ueding E, Fischer T, Seifert J. Effects of a treadmill and oculomotor dual-task intervention vs. -nordic walking on balance in Parkinson's disease patients - a pilot study. Clin Park Relat Disord. 2025 Sep 8;13:100392. doi: 10.1016/j.prdoa.2025.100392. eCollection 2025.

    PMID: 41492353BACKGROUND
  • Su D, Cui Y, He C, Yin P, Bai R, Zhu J, Lam JST, Zhang J, Yan R, Zheng X, Wu J, Zhao D, Wang A, Zhou M, Feng T. Projections for prevalence of Parkinson's disease and its driving factors in 195 countries and territories to 2050: modelling study of Global Burden of Disease Study 2021. BMJ. 2025 Mar 5;388:e080952. doi: 10.1136/bmj-2024-080952.

    PMID: 40044233BACKGROUND
  • Bailo G, Saibene FL, Bandini V, Arcuri P, Salvatore A, Meloni M, Castagna A, Navarro J, Lencioni T, Ferrarin M, Carpinella I. Characterization of Walking in Mild Parkinson's Disease: Reliability, Validity and Discriminant Ability of the Six-Minute Walk Test Instrumented with a Single Inertial Sensor. Sensors (Basel). 2024 Jan 20;24(2):662. doi: 10.3390/s24020662.

    PMID: 38276354BACKGROUND
  • Culicetto L, Cardile D, Marafioti G, Lo Buono V, Ferraioli F, Massimino S, Di Lorenzo G, Sorbera C, Brigandi A, Vicario CM, Quartarone A, Marino S. Recent advances (2022-2024) in eye-tracking for Parkinson's disease: a promising tool for diagnosing and monitoring symptoms. Front Aging Neurosci. 2025 May 21;17:1534073. doi: 10.3389/fnagi.2025.1534073. eCollection 2025.

    PMID: 40469846BACKGROUND
  • Lorenzo-Garcia P, Cavero-Redondo I, Nunez de Arenas-Arroyo S, Guzman-Pavon MJ, Priego-Jimenez S, Alvarez-Bueno C. Effects of physical exercise interventions on balance, postural stability and general mobility in Parkinson's disease: a network meta-analysis. J Rehabil Med. 2024 Feb 1;56:jrm10329. doi: 10.2340/jrm.v56.10329.

    PMID: 38298133BACKGROUND
  • Yang Y, Wang G, Zhang S, Wang H, Zhou W, Ren F, Liang H, Wu D, Ji X, Hashimoto M, Wei J. Efficacy and evaluation of therapeutic exercises on adults with Parkinson's disease: a systematic review and network meta-analysis. BMC Geriatr. 2022 Oct 21;22(1):813. doi: 10.1186/s12877-022-03510-9.

    PMID: 36271367BACKGROUND
  • Waterston JA, Hawken MB, Tanyeri S, Jantti P, Kennard C. Influence of sensory manipulation on postural control in Parkinson's disease. J Neurol Neurosurg Psychiatry. 1993 Dec;56(12):1276-81. doi: 10.1136/jnnp.56.12.1276.

    PMID: 8270927BACKGROUND
  • Liu WY, Tung TH, Zhang C, Shi L. Systematic review for the prevention and management of falls and fear of falling in patients with Parkinson's disease. Brain Behav. 2022 Aug;12(8):e2690. doi: 10.1002/brb3.2690. Epub 2022 Jul 14.

    PMID: 35837986BACKGROUND
  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PMID: 36602886BACKGROUND
  • Mildner S, Hotz I, Kubler F, Rausch L, Stampfer-Kountchev M, Panzl J, Brenneis C, Seebacher B. Effects of activity-oriented physiotherapy with and without eye movement training on dynamic balance, functional mobility, and eye movements in patients with Parkinson's disease: An assessor-blinded randomised controlled pilot trial. PLoS One. 2024 Jun 14;19(6):e0304788. doi: 10.1371/journal.pone.0304788. eCollection 2024.

    PMID: 38875243BACKGROUND
  • Yang R, Sun M, Chen W, Feng H, Chen B, Liu Y, He Q, Wang L, Zou C, Luo X, Li Z, Fu A, Qiao F, Tang H, Yang J, Ren H. Global, regional and national burden of Parkinson's disease, 1990-2021: Update from the GBD 2021 study. J Neurol Sci. 2026 Jan 15;480:125703. doi: 10.1016/j.jns.2025.125703. Epub 2025 Dec 18.

    PMID: 41435482BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Nasrin Salimian

CONTACT

Mohammad Ali Tabibi, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A research project collaborator who is not informed about grouping of participants will obtain outcome measurements of the functional tests. Outcome adjudicators and data analysts will be kept blinded to the allocation. Moreover, all investigators, staff, and participants will be kept masked to outcome measurements and trial results.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly allocated to intervention group or control group and will be examined in the same way.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 13, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) that underlie the results reported in the published article, after deidentification are to be shared.

Shared Documents
SAP
Time Frame
The data will be available after the paper is published. No end date.
Access Criteria
Not applicable. It will be accessible for public.

Locations