- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07525973
The Effect of Eye Exercises in Parkinson's Disease
The Effect of Eye Exercises on Physical Function, Balance, and Fall Risk in Patients With Parkinson's Disease: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Parkinson's disease is a progressive neurodegenerative disorder characterized not only by tremor and bradykinesia, but also by impaired gait, postural instability, reduced turning ability, slowed mobility, and increased fear of falling. These impairments are major contributors to functional limitation, reduced independence, and decreased quality of life in people with Parkinson's disease. Recent systematic reviews and network meta-analyses have demonstrated that exercise interventions can improve physical function, balance, gait performance, and mobility-related outcomes in this population. However, balance impairment and falls remain highly prevalent despite conventional rehabilitation approaches, highlighting the need for additional targeted non-pharmacological interventions.
Visual and oculomotor dysfunction are increasingly recognized as clinically relevant features of Parkinson's disease. Abnormalities in saccadic eye movements, smooth pursuit, gaze stabilization, and visuomotor control have been reported in patients with Parkinson's disease and may contribute to impaired postural control, gait dysfunction, and difficulties with movement coordination. Recent studies in neurorehabilitation and eye-movement research suggest that eye exercises and visually guided training may positively influence balance control, mobility, and motor-related performance by enhancing sensory integration and visuomotor coordination.
Emerging rehabilitation studies have reported promising effects of structured eye-movement interventions on dynamic balance, walking performance, and functional mobility in individuals with Parkinson's disease. In addition, recent advances in eye-tracking and oculomotor assessment research further support the potential therapeutic relevance of visually guided interventions in Parkinson's disease rehabilitation. Nevertheless, high-quality randomized controlled trials investigating supervised eye-exercise programs in clinical settings remain limited.
Therefore, the present study will investigate the effects of a structured supervised in-center eye-exercise program on physical function, dynamic balance, and fall-related concern in patients with Parkinson's disease. The intervention will be delivered face-to-face in a controlled rehabilitation setting to enhance safety, standardization, treatment fidelity, and adherence. By focusing on clinically meaningful functional outcomes, this trial aims to determine whether supervised eye exercises may represent a practical and effective adjunct rehabilitation strategy for improving mobility- and balance-related outcomes in people with Parkinson's disease.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nasrin Salimian
- Phone Number: +989132-51202
- Email: statisrin@gmail.com
Study Contact Backup
- Name: Mohammad Ali Tabibi, Dr
- Phone Number: +989133184624
- Email: m.tabibi@ut.ac.ir
Study Locations
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Isfahan, Iran
- Pardis specialized wellness institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Supervised In-Center Eye Exercise Group
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.
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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.
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No Intervention: Control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in physical function
Time Frame: Baseline and 8 weeks
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Assessed with the 6-Minute Walk Test.
Greater distance indicates better physical function and walking endurance.
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Baseline and 8 weeks
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Change in dynamic balance
Time Frame: Baseline and 8 weeks
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Assessed with the Mini-BESTest total score.
Higher scores indicate better dynamic balance and postural control.
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Baseline and 8 weeks
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Change in fall-related concern
Time Frame: Baseline and 8 weeks
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Assessed with the Falls Efficacy Scale-International (FES-I).
Higher scores indicate greater concern about falling.
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Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in functional mobility
Time Frame: Baseline and 8 weeks
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Assessed with the Timed Up and Go test.
Shorter completion times indicate better mobility.
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Baseline and 8 weeks
|
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Change in gait speed
Time Frame: Baseline and 8 weeks
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Assessed with the 10-Meter Walk Test.
Faster walking speed indicates better gait performance.
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Baseline and 8 weeks
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Change in lower-limb functional strength
Time Frame: Baseline and 8 weeks
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Assessed with the 30-second sit-to-stand test.
More repetitions indicate better lower-limb functional strength and endurance.
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Baseline and 8 weeks
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Collaborators and Investigators
Investigators
- Study Director: Mohammad Ali Tabibi, Dr, Pardis specialized wellness institute
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PA26PKD-2-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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