NCT07525973

Brief Summary

Parkinson's disease is commonly associated with impaired gait, postural instability, reduced physical function, and increased concern about falling, all of which contribute substantially to disability and reduced quality of life. Exercise-based rehabilitation is increasingly recommended as a core non-pharmacological strategy for improving mobility and balance in people with Parkinson's disease. In parallel, recent clinical and neurorehabilitation research suggests that eye-movement and gaze-stabilization training may influence postural control, visuomotor integration, and movement performance in neurological disorders, including Parkinson's disease. This randomized controlled trial will evaluate whether a supervised in-center eye-exercise program can improve dynamic balance, functional mobility, gait performance, and fall-related concern in patients with Parkinson's disease.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

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
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Completed
Last Updated

September 15, 2026

Status Verified

September 1, 2026

Enrollment Period

5 months

First QC Date

April 6, 2026

Last Update Submit

September 10, 2026

Conditions

Keywords

Parkinson diseaseEye exercisesBalanceFall riskPhysical functionFunctional mobilityGaitPostural stability

Outcome Measures

Primary Outcomes (1)

  • Change in dynamic balance

    Dynamic balance will be assessed using the Mini-BESTest total score. The Mini-BESTest evaluates anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Higher scores indicate better dynamic balance and postural control.

    Baseline and 8 weeks

Secondary Outcomes (5)

  • Change in functional mobility

    Baseline and 8 weeks

  • Change in gait speed

    Baseline and 8 weeks

  • Change in fall-related concern

    Baseline and 8 weeks

  • Change in walking endurance

    Baseline and 8 weeks

  • Number of participants with adverse events during the intervention period

    Baseline and 8 weeks

Study Arms (2)

Supervised In-Center Eye Exercise Group

EXPERIMENTAL

Participants will receive a structured eye-exercise program designed to train oculomotor control, gaze stability, and eye-head coordination. The program will be delivered face-to-face in the center during supervised sessions. Each session will last approximately 30 to 45 minutes, 3 sessions per week for 8 weeks.

Behavioral: Supervised In-Center Eye Exercises

Control group

NO INTERVENTION

Participants allocated to the control arm will receive standard neurological care and routine advice to maintain their usual daily activities. They will not receive the structured eye-exercise program during the intervention period.

Interventions

The participants in the study group will perform the eye-exercise program in a standardized seated position under supervision by trained study personnel in a rehabilitation/clinic setting. The exercises will be administered face-to-face and will include progressive visual fixation, smooth pursuit, saccadic eye movements, convergence/divergence, gaze stabilization, and combined eye-head coordination tasks. Progression will be based on increases in movement speed, number of repetitions, task complexity, and participant tolerance, while maintaining the standardized seated position and ensuring safety throughout the intervention.

Supervised In-Center Eye Exercise Group

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18-80 years with clinically diagnosed idiopathic Parkinson's disease;
  • Hoehn and Yahr stage 1-3;
  • Stable antiparkinsonian medication regimen for at least 4 weeks before enrollment;
  • Able to stand unaided and walk independently with or without an assistive device;
  • Adequate corrected vision to perform eye-exercise tasks;
  • Able to understand and follow simple exercise instructions;
  • Able to attend supervised in-center sessions three times per week for 8 weeks;
  • Able to provide written informed consent.

You may not qualify if:

  • Unstable cardiovascular, orthopedic, vestibular, or neurological condition interfering with safe participation;
  • Active infection or acute medical illness;
  • Severe uncorrected visual impairment preventing participation in eye-exercise tasks;
  • Recent myocardial infarction or stroke within the past 3 months;
  • Change in antiparkinsonian medication during the 4 weeks before enrollment or planned medication change during the intervention period;
  • Severe dizziness, uncontrolled vertigo, or other condition that may be worsened by eye-head coordination exercises;
  • Any other condition judged by the study physician to make participation unsafe.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pardis specialized wellness institute

Isfahan, Iran

Location

Related Publications (13)

  • 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
  • Godi M, Arcolin I, Giardini M, Corna S, Schieppati M. Responsiveness and minimal clinically important difference of the Mini-BESTest in patients with Parkinson's disease. Gait Posture. 2020 Jul;80:14-19. doi: 10.1016/j.gaitpost.2020.05.004. Epub 2020 May 17.

    PMID: 32464537BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mohammad Ali Tabibi, Dr

    Pardis Specialized Wellness Institute

    STUDY DIRECTOR

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. Due to the nature of the behavioral intervention, participants and intervention personnel cannot be blinded to group allocation. Outcome assessors and data analysts will remain blinded to group allocation. Participants will be instructed not to disclose their group assignment to the outcome assessor.
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

October 1, 2026

Study Completion

October 1, 2026

Last Updated

September 15, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the published results will be made available upon reasonable request to qualified researchers after publication of the main article.

Shared Documents
SAP
Time Frame
The data will be available after the paper is published. No end date.
Access Criteria
Researchers must submit a methodologically sound proposal. Requests will be reviewed by the principal investigator, and data will be shared after approval and, if required, a data-sharing agreement.

Locations