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 physical function, balance, and fall-related concern in patients with Parkinson's disease.

Trial Health

75
On Track

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
1mo left

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

Study Progress75%
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

July 6, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

April 6, 2026

Last Update Submit

July 2, 2026

Conditions

Keywords

Parkinson diseaseEye exercisesBalanceFall riskPhysical functionFunctional mobilityGaitPostural stability

Outcome Measures

Primary Outcomes (3)

  • Change in physical function

    Assessed with the 6-Minute Walk Test. Greater distance indicates better physical function and walking endurance.

    Baseline and 8 weeks

  • Change in dynamic balance

    Assessed with the Mini-BESTest total score. Higher scores indicate better dynamic balance and postural control.

    Baseline and 8 weeks

  • Change in fall-related concern

    Assessed with the Falls Efficacy Scale-International (FES-I). Higher scores indicate greater concern about falling.

    Baseline and 8 weeks

Secondary Outcomes (3)

  • Change in functional mobility

    Baseline and 8 weeks

  • Change in gait speed

    Baseline and 8 weeks

  • Change in lower-limb functional strength

    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 supervised rehabilitation/clinic setting. The exercises will initially be performed in a seated position, with selected tasks progressed to standing positions as tolerated and considered safe by the supervising therapist. The exercises will be administered face-to-face by trained study personnel. The program will include progressive visual fixation, smooth pursuit, saccadic eye movements, convergence/divergence, gaze stabilization, and combined eye-head coordination tasks, with gradual progression in speed and complexity according to participant tolerance and safety.

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:

  • Aged 18 years and older Clinically diagnosed idiopathic Parkinson's disease Hoehn and Yahr stage 1-3 Stable antiparkinsonian medication regimen Able to stand unaided and walk with or without an assistive device Able to provide written informed consent Able to attend supervised in-center exercise sessions Able to follow simple exercise instructions

You may not qualify if:

  • Severe cognitive impairment Unstable cardiovascular, orthopedic, or neurologic conditions that interfere with safe participation Active infection or acute medical illness Hemodynamic instability Severe visual impairment or other sensory impairment that prevents participation Recent myocardial infarction or stroke Unstable or changing antiparkinsonian medication regimen Any other condition that, in the judgment of the study physician, makes participation unsafe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pardis specialized wellness institute

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

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. 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

July 6, 2026

Record last verified: 2026-07

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