The Effect of Eye Exercises on Balance, Functional Mobility and Fall-Related Concern in Patients With Parkinson's Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change in balance
研究概览
简要总结
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.
详细描述
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 under direct supervision in a controlled rehabilitation/clinic setting. 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.
All functional assessments will be performed at approximately the same time of day and in the participant's usual "ON" medication state, preferably 1-2 hours after antiparkinsonian medication intake, where feasible. Medication timing will be recorded at each assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
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.
干预措施: Supervised In-Center Eye Exercises (Behavioral)
结局指标
主要结局
Change in balance
时间窗: Baseline and Week 8
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.
Change in functional mobility and fall risk
时间窗: Baseline and Week 8
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.
Change in dynamic balance
时间窗: Baseline and 8 weeks
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.
次要结局
- Change in walking capacity(Baseline and Week 8)
- Change in eye-movement performance(Baseline and Week 8)
- Change in functional mobility(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)