Salisbury NHS Foundation Trust, Salisbury, Wiltshire, UK.
Odstock Medical Limited, Salisbury District Hospital, Salisbury, Wiltshire, UK.
Clin Rehabil. 2021 Apr;35(4):546-557. doi: 10.1177/0269215520972519. Epub 2020 Dec 1.
To assess the feasibility of a multi-site randomised controlled trial to evaluate the effect of functional electrical stimulation on bradykinesia in people with Parkinson's disease.
A two-arm assessor blinded randomised controlled trial with an 18 weeks intervention period and 4 weeks post-intervention follow-up.
Two UK hospitals; a therapy outpatient department in a district general hospital and a specialist neuroscience centre.
A total of 64 participants with idiopathic Parkinson's disease and slow gait <1.25 ms.
Functional electrical stimulation delivered to the common peroneal nerve while walking in addition to standard care compared with standard care alone.
Feasibility aims included the determination of sample size, recruitment and retention rates, acceptability of the protocol and confirmation of the primary outcome measure. The outcome measures were 10 m walking speed, Unified Parkinson's Disease Rating Scale (UPDRS), Mini Balance Evaluation Systems Test, Parkinson's Disease Questionnaire-39, EuroQol 5-dimension 5-level, New Freezing of Gait questionnaire, Falls Efficacy Score International and falls diary. Participants opinion on the study design and relevance of outcome measures were evaluated using an embedded qualitative study.
There was a mean difference between groups of 0.14 ms (CI 0.03, 0.26) at week 18 in favour of the treatment group, which was maintained at week 22, 0.10 ms (CI -0.05, 0.25). There was a mean difference in UPDRS motor examination score of -3.65 (CI -4.35, 0.54) at week 18 which was lost at week 22 -0.91 (CI -2.19, 2.26).
The study design and intervention were feasible and supportive for a definitive trial. While both the study protocol and intervention were acceptable, recommendations for modifications are made.
评估一项多中心随机对照试验的可行性，以评估功能性电刺激对帕金森病患者运动迟缓的影响。
一项为期 18 周的干预期和 4 周的干预后随访的双臂评估员盲法随机对照试验。
两家英国医院；一家地区综合医院的治疗门诊和一家专门的神经科学中心。
共 64 名特发性帕金森病且步行速度<1.25ms 的患者。
在行走时对腓总神经施加功能性电刺激，除了标准护理外，与单独接受标准护理进行比较。
可行性目标包括确定样本量、招募和保留率、方案的可接受性以及确认主要结局测量指标。测量指标为 10m 步行速度、统一帕金森病评定量表（UPDRS）、简易平衡评估系统测试、帕金森病问卷-39、欧洲五维健康量表 5 级、新冻结步态问卷、跌倒效能感量表国际版和跌倒日记。使用嵌入式定性研究评估参与者对研究设计和结局测量指标相关性的意见。
治疗组在第 18 周的组间平均差异为 0.14ms（CI 0.03，0.26），在第 22 周时保持在 0.10ms（CI-0.05，0.25）。在第 18 周时，UPDRS 运动检查评分的平均差异为-3.65（CI-4.35，0.54），而在第 22 周时则降至-0.91（CI-2.19，2.26）。
研究设计和干预措施是可行的，并为确定性试验提供了支持。尽管研究方案和干预措施都可以接受，但仍提出了一些修改建议。
