眼保健操对帕金森病患者运动表现、平衡能力和跌倒风险的影响
同步家庭远程眼部锻炼对帕金森病患者运动功能、平衡能力及跌倒风险的影响:一项随机对照试验
研究概览
详细说明
帕金森病(PD)是一种常见的神经退行性疾病,由中脑黑质致密部多巴胺能神经元的进行性丧失引起。 这导致多巴胺水平降低,损害大脑控制和协调运动的能力,从而产生特征性运动症状,如运动迟缓、强直、震颤和姿势不稳。
全球帕金森病的汇总患病率估计为每1000人中有1.51例,男性患病率较高,并随年龄增长显著增加;预测显示,由于人口老龄化,到2050年病例数将大幅上升。 大约60%的帕金森病患者每年会跌倒,其中三分之二经历反复跌倒,导致严重的继发性并发症、骨折、行动能力下降、跌倒恐惧和死亡风险增加。
环境和遗传因素会增加帕金森病的风险,虽然尚无治愈性治疗方法,但药物管理(如左旋多巴)和体育活动是控制症状的核心。 规律体育活动和锻炼已被证明可改善帕金森病患者的行动能力、步态、平衡和姿势稳定性,长期维持活动水平与姿势和步态功能、日常生活活动和处理速度的恶化减缓相关。 最近一篇Cochrane综述证实,在轻度至中度帕金森病患者中,运动干预可将跌倒率降低约35%,跌倒者比例减少约10%,且完全监督的项目显示出更大益处。
帕金森病中眼动功能障碍(如扫视不足、平滑追踪受损和会聚不足)已有充分记录,并导致视觉运动缺陷,加剧平衡和步态障碍。 虽然研究已探讨帕金森病的眼动表现及一般运动对平衡和跌倒的影响,但针对孤立眼(眼动)锻炼作为靶向干预的证据仍然有限。 结合跑步机行走的双重任务眼动训练的初步发现显示单侧和静态平衡参数有所改善,且包含眼动成分的前庭康复在小规模帕金森病队列中显示出对眼动功能和平衡的积极影响。 先前尚无随机试验直接评估结构化眼动锻炼对帕金森病患者运动表现、平衡和跌倒风险的孤立影响。
本研究通过评估一项专为帕金森病患者设计的为期8周的同步居家远程眼动锻炼计划来填补这一空白,该计划通过电话会议提供,以提高可及性、依从性和安全性,同时最大限度地减少与临床治疗相关的成本和出行负担。
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Isfahan、伊朗
- Pardis specialized wellness institute
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
入选标准:
- 年龄在18岁及以上
- 临床诊断为特发性帕金森病(Hoehn和Yahr分期1-3期)
- 抗帕金森病药物方案稳定至少1个月
- 能够独立行走或在最小辅助下行走(允许使用手杖/助行器)
- 获得其神经科医生的许可
- 具备决策能力,能够给予参与研究的知情同意
- 拥有智能设备(例如智能手机、笔记本电脑或平板电脑)并可访问互联网
排除标准:
- 心脏状态不稳定(心绞痛、失代偿性充血性心力衰竭、严重心律失常等)
- 活动性感染或急性内科疾病
- 血流动力学不稳定
- 严重认知障碍(简易精神状态检查 < 24分)
- 无法进行锻炼(下肢截肢未安装假肢,或静息/轻微活动时出现严重肌肉骨骼疼痛)
- 近期跌倒导致骨折或住院(3个月内)
- 帕金森病治疗不稳定或正在调整(滴定)药物方案
- 过去3个月内发生心肌梗死或中风
- 严重视力障碍无法通过眼镜矫正
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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.
|
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.
|
|
无干预: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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in dynamic balance
大体时间: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.
|
Baseline and 8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in fall-related concern
大体时间:Baseline and 8 weeks
|
Assessed with the Falls Efficacy Scale-International (FES-I).
Higher scores indicate greater concern about falling.
|
Baseline and 8 weeks
|
|
Change in gait speed
大体时间:Baseline and 8 weeks
|
Assessed with the 10-Meter Walk Test.
Faster walking speed indicates better gait performance.
|
Baseline and 8 weeks
|
|
Change in functional mobility
大体时间:Baseline and 8 weeks
|
Assessed with the Timed Up and Go test.
Shorter completion times indicate better functional mobility.
|
Baseline and 8 weeks
|
|
Change in walking endurance
大体时间:Baseline and 8 weeks
|
Assessed with the 6-Minute Walk Test.
Greater distance indicates better walking endurance and physical function.
|
Baseline and 8 weeks
|
|
Number of participants with adverse events during the intervention period
大体时间:Baseline and 8 weeks
|
Adverse events will include dizziness, nausea, headache, eye strain, worsening balance, near-falls, falls, musculoskeletal discomfort, or any event requiring session termination or medical evaluation.
|
Baseline and 8 weeks
|
合作者和调查者
调查人员
- 研究主任:Mohammad Ali Tabibi, Dr、Pardis specialized wellness institute
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- PA26PKD-2-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.