Department of Rehabilitation Science, Clinic for Rehabilitation Münster, Münster, Austria.
Department of Sport Science, University of Innsbruck, Innsbruck, Austria.
PLoS One. 2024 Jun 14;19(6):e0304788. doi: 10.1371/journal.pone.0304788. eCollection 2024.
To describe changes in balance, walking speed, functional mobility, and eye movements following an activity-oriented physiotherapy (AOPT) or its combination with eye movement training (AOPT-E) in patients with Parkinson's disease (PD). To explore the feasibility of a full-scale randomised controlled trial (RCT).
Using an assessor-blinded pilot RCT, 25 patients with PD were allocated to either AOPT or AOPT-E. Supervised interventions were performed 30 minutes, 4x/weekly, for 4 weeks, alongside inpatient rehabilitation. Outcomes were assessed at baseline and post-intervention, including dynamic balance, walking speed, functional and dual-task mobility, ability to safely balance, health-related quality of life (HRQoL), depression, and eye movements (number/duration of fixations) using a mobile eye tracker. Freezing of gait (FOG), and falls-related self-efficacy were assessed at baseline, post-intervention, and 4-week follow-up. Effect sizes of 0.10 were considered weak, 0.30 moderate, and ≥0.50 strong. Feasibility was assessed using predefined criteria: recruitment, retention and adherence rates, adverse events, falls, and post-intervention acceptability using qualitative interviews.
Improvements were observed in dynamic balance (effect size r = 0.216-0.427), walking speed (r = 0.165), functional and dual-task mobility (r = 0.306-0.413), ability to safely balance (r = 0.247), HRQoL (r = 0.024-0.650), and depression (r = 0.403). Falls-related self-efficacy (r = 0.621) and FOG (r = 0.248) showed varied improvements, partly sustained at follow-up. Eye movement improvements were observed after AOPT-E only. Feasibility analysis revealed that recruitment was below target, with less than two patients recruited per month due to COVID-19 restrictions. Feasibility targets were met, with a retention rate of 96% (95% confidence interval [CI]: 77.68-99.79) and a 98.18% (95% CI: 96.12-99.20) adherence rate, exceeding the targets of 80% and 75%, respectively. One adverse event unrelated to the study intervention confirmed intervention safety, and interview data indicated high intervention acceptability.
AOPT-E and AOPT appeared to be effective in patients with PD. Feasibility of a larger RCT was confirmed and is needed to validate results.
描述帕金森病患者接受以活动为导向的物理治疗（AOPT）或其与眼球运动训练（AOPT-E）联合治疗后的平衡、行走速度、功能移动性和眼球运动变化。探索全面随机对照试验（RCT）的可行性。
采用盲法评估的前瞻性RCT，将 25 例帕金森病患者分为 AOPT 或 AOPT-E 组。在 4 周的住院康复期间，每周进行 4 次，每次 30 分钟，进行监督干预。在基线和干预后评估结果，包括动态平衡、行走速度、功能和双重任务移动性、安全平衡能力、健康相关生活质量（HRQoL）、抑郁和使用移动眼动追踪器评估眼球运动（注视次数/持续时间）。在基线、干预后和 4 周随访时评估冻结步态（FOG）和跌倒相关自我效能感。效应大小为 0.10 被认为是弱的，0.30 是中等的，≥0.50 是强的。使用以下标准评估可行性：招募、保留和依从率、不良事件、跌倒以及干预后的可接受性，采用定性访谈。
动态平衡（效应大小 r = 0.216-0.427）、行走速度（r = 0.165）、功能和双重任务移动性（r = 0.306-0.413）、安全平衡能力（r = 0.247）、HRQoL（r = 0.024-0.650）和抑郁（r = 0.403）均有改善。跌倒相关自我效能感（r = 0.621）和 FOG（r = 0.248）也有不同程度的改善，部分改善在随访中得以维持。仅在接受 AOPT-E 后观察到眼球运动改善。可行性分析表明，由于 COVID-19 限制，招募低于目标，每月不到两名患者参与。保留率为 96%（95%置信区间 [CI]：77.68-99.79），依从率为 98.18%（95% CI：96.12-99.20），均超过 80%和 75%的目标，证实了可行性。1 例与研究干预无关的不良事件证实了干预的安全性，访谈数据表明干预具有较高的可接受性。
AOPT-E 和 AOPT 似乎对帕金森病患者有效。证实了更大规模 RCT 的可行性，需要进一步验证结果。
