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Feasibility and acceptability of the HOLObalance telerehabilitation system compared with standard care for older adults at risk of falls: the HOLOBalance assessor blinded pilot randomised controlled study
Age and Ageing ( IF 6.0 ) Pub Date : 2024-10-02 , DOI: 10.1093/ageing/afae214 Marousa Pavlou, Carol Ann Flavell, Fariba Mostajeran Gourtani, Christos Nikitas, Dimitris Kikidis, Athanasios Bibas, Dimitris Gatsios, Vassilis Tsakanikas, Dimitrios I Fotiadis, Dimitrios Koutsouris, Frank Steinicke, Isabelle Daniela Walz, Christoph Maurer, Sofia Papadopoulou, Michalis Tsoukatos, Athanasios Pardalis, Doris-Eva Bamiou
Age and Ageing ( IF 6.0 ) Pub Date : 2024-10-02 , DOI: 10.1093/ageing/afae214 Marousa Pavlou, Carol Ann Flavell, Fariba Mostajeran Gourtani, Christos Nikitas, Dimitris Kikidis, Athanasios Bibas, Dimitris Gatsios, Vassilis Tsakanikas, Dimitrios I Fotiadis, Dimitrios Koutsouris, Frank Steinicke, Isabelle Daniela Walz, Christoph Maurer, Sofia Papadopoulou, Michalis Tsoukatos, Athanasios Pardalis, Doris-Eva Bamiou
Background Falls have high socioeconomic costs. Information and communication technologies may support provision and monitoring of multisensory (MSR) physiotherapy programmes. The HOLOBalance platform used augmented reality holograms to provide patient-centred, individualised MSR. Objectives To determine the platform’s safety, acceptability and feasibility, investigate functional gait and dynamic balance benefits and provide data for a definitive trial. Design and setting Single-blinded pilot randomised controlled feasibility study. Interventions were conducted at clinical sites or participants’ homes in three European countries. Participants Community-dwelling older adults (median age 73 years; 64.2% female) at risk of falls were enrolled (May 2020-August 2021). Methods Participants were randomised to an 8-week clinic or home-based telerehabilitation MSR or OTAGO (control group) programme. Compliance, satisfaction, and adverse events determined feasibility. Clinical outcomes, assessed (blinded) within one-week prior to and post-intervention, included functional gait assessment (FGA), Mini BESTest and cognitive function. Results Randomisation to completion rate was 76.15% with 109 participants recruited (n = 289 screened). Drop-out rate was similar between groups. Adverse events were reported (n = 3) in the control group. Sixty-nine percent would recommend the HOLOBalance intervention. Findings were similar for the home and clinic-based arms of each intervention; data was combined for analysis. FGA (95%CI [1.63, 4.19]) and Mini-BESTest (95%CI [1.46, 3.93]) showed greater improvement in the HOLOBalance group with a clinically meaningful change of 4/30 noted for the FGA. Conclusions HOLObalance was feasible to implement and acceptable to older adults at risk of falls, with FGA and Mini-BEST improvements exceeding those for the OTAGO programme. A definitive trial is warranted.
中文翻译:
与有跌倒风险的老年人的标准护理相比,HOLObalance 远程康复系统的可行性和可接受性:HOLOBalance 评估员盲法试点随机对照研究
背景 瀑布具有很高的社会经济成本。信息和通信技术可能支持多感官 (MSR) 物理治疗计划的提供和监测。HOLOBalance 平台使用增强现实全息图来提供以患者为中心的个性化 MSR。目标 确定平台的安全性、可接受性和可行性,研究功能步态和动态平衡的好处,并为最终试验提供数据。设计和设置 单盲试点随机对照可行性研究。干预在 3 个欧洲国家的临床地点或参与者家中进行。参与者 有跌倒风险的社区老年人(中位年龄 73 岁;64.2% 为女性)被纳入(2020 年 5 月至 2021 年 8 月)。方法 参与者被随机分配到为期 8 周的诊所或家庭远程康复 MSR 或 OTAGO (对照组) 计划。依从性、满意度和不良事件决定了可行性。干预前后 1 周内评估 (盲法) 的临床结局包括功能步态评估 (FGA) 、 Mini BESTest 和认知功能。结果随机化至完成率为 76.15%,招募了 109 名参与者 (n = 289 筛选)。各组间的退出率相似。对照组报告了不良事件 (n = 3)。69% 的人会推荐 HOLOBalance 干预。每种干预措施的家庭组和诊所组的结果相似;合并数据进行分析。FGA (95% CI [1.63, 4.19]) 和 Mini-BESTest (95% CI [1.46, 3.93]) 显示 HOLOBalance 组的改善更大,FGA 的临床意义变化为 4/30。 结论 HOLObalance 实施是可行的,并且对于有跌倒风险的老年人来说是可以接受的,FGA 和 Mini-BEST 的改善超过了 OTAGO 计划。需要进行确定性试验。
更新日期:2024-10-02
中文翻译:
与有跌倒风险的老年人的标准护理相比,HOLObalance 远程康复系统的可行性和可接受性:HOLOBalance 评估员盲法试点随机对照研究
背景 瀑布具有很高的社会经济成本。信息和通信技术可能支持多感官 (MSR) 物理治疗计划的提供和监测。HOLOBalance 平台使用增强现实全息图来提供以患者为中心的个性化 MSR。目标 确定平台的安全性、可接受性和可行性,研究功能步态和动态平衡的好处,并为最终试验提供数据。设计和设置 单盲试点随机对照可行性研究。干预在 3 个欧洲国家的临床地点或参与者家中进行。参与者 有跌倒风险的社区老年人(中位年龄 73 岁;64.2% 为女性)被纳入(2020 年 5 月至 2021 年 8 月)。方法 参与者被随机分配到为期 8 周的诊所或家庭远程康复 MSR 或 OTAGO (对照组) 计划。依从性、满意度和不良事件决定了可行性。干预前后 1 周内评估 (盲法) 的临床结局包括功能步态评估 (FGA) 、 Mini BESTest 和认知功能。结果随机化至完成率为 76.15%,招募了 109 名参与者 (n = 289 筛选)。各组间的退出率相似。对照组报告了不良事件 (n = 3)。69% 的人会推荐 HOLOBalance 干预。每种干预措施的家庭组和诊所组的结果相似;合并数据进行分析。FGA (95% CI [1.63, 4.19]) 和 Mini-BESTest (95% CI [1.46, 3.93]) 显示 HOLOBalance 组的改善更大,FGA 的临床意义变化为 4/30。 结论 HOLObalance 实施是可行的,并且对于有跌倒风险的老年人来说是可以接受的,FGA 和 Mini-BEST 的改善超过了 OTAGO 计划。需要进行确定性试验。