Data_Sheet_1_Functional balance training in people with Parkinson’s disease: a protocol of balanceHOME randomized control trial with crossover.pdf

IntroductionBalance disturbances in Parkinson’s Disease (PD) are usually assessed in a single-task as well as standard balance physiotherapy is carried out in isolated environments. Conversely, daily activities are developed in highly challenging environments. Although functional balance training (FBT) is included in the latest protocols, several methodological issues have not yet been considered. In the proposed single-blinded randomized control trial with crossover (NCT04963894), the aims are (1) to quantify the effects achieved by domiciliary FBT (balanceHOME program) in participants with and without cognitive impairment, and (2) to compare them with the effects of a passive-control period and a conventional face-to-face physiotherapy program for PD.
MethodsThe initial recruitment was estimated at 112 people with idiopathic PD. Two-thirds of the participants will be randomized to one of the two groups to make the crossover. In contrast, the other third will do a face-to-face group program only. The balanceHOME protocol consists of challenging balance exercises incorporated into functional daily tasks, developed in-home and conducted two times per week for 60-min over an 8-weeks period. The primary strategy will consist of splitting functional tasks of daily life into static and dynamic balance components, besides standardized facilitate and disturbing strategies to execution of each exercise. Biomechanics and clinical performance of balance and gait, perception of quality of life, cognitive and mental functioning, and severity of PD will be measured at baseline (T0), post-8 weeks training (T1), and follow-up (T2).
ResultsThe primary outcome of the study will be the center of pressure sway area. The secondary outcomes consist of biomechanics and clinical variables related to static and dynamic balance. Outcomes from biomechanical of gait, quality of life, cognitive and mental state, and severity of PD, represent the tertiary outcomes.
DiscussionThe balanceHOME program standardizes the FBT in demanding and daily environments for people with PD who prefer individualized treatment from home. This is the first time that the effects of group versus individual balance rehabilitation have been compared in people with and without cognitive impairment and evaluated in complex environments. This still-to-be-finished study will open the possibility of new strategies according to changes in post-pandemic therapeutic approaches.

引言
帕金森病（Parkinson’s Disease, PD）患者的平衡障碍通常以单任务模式进行评估，常规平衡物理治疗也多在孤立环境中开展。然而，日常活动实际处于高度挑战性的环境中。尽管最新的康复方案已纳入功能性平衡训练（Functional Balance Training, FBT），但仍有诸多方法学问题尚未得到考量。本项单盲交叉随机对照试验（临床试验编号：NCT04963894）旨在达成两大研究目标：（1）量化居家功能性平衡训练（balanceHOME方案）对伴与不伴认知障碍的帕金森病患者的干预效果；（2）将该效果与被动对照期以及针对帕金森病的常规面对面物理治疗方案的效果进行对比。

研究方法
本研究初始预估招募112名特发性帕金森病患者。其中三分之二的受试者将被随机分配至两组之一以完成交叉试验设计，剩余三分之一受试者仅参与面对面团体康复方案。balanceHOME方案将高挑战性平衡训练融入日常功能性任务，受试者居家完成训练，每周2次，每次60分钟，持续8周。本研究的核心策略为将日常功能性任务拆解为静态与动态平衡组分，并针对每项训练的实施设置标准化的辅助与干扰方案。分别在基线（T0）、8周训练后（T1）及随访期（T2）评估平衡与步态的生物力学及临床表现、生活质量感知、认知与精神功能，以及帕金森病严重程度。

研究结果
本研究的主要结局指标为压力中心晃动面积。次要结局指标包括与静态及动态平衡相关的生物力学与临床变量。步态生物力学、生活质量、认知与精神状态，以及帕金森病严重程度相关指标为三级结局指标。

讨论
balanceHOME方案将功能性平衡训练标准化，适用于偏好居家个性化治疗的帕金森病患者，训练场景贴合日常高挑战性环境。本研究首次针对伴与不伴认知障碍的帕金森病患者，在复杂环境中对比团体与个体化平衡康复的效果差异。这项尚未完成的研究将为后疫情时代治疗策略的变革提供新型康复方案的探索方向。