RECOVERYFUN: An Integrated VR-based Tele-rehabilitation Platform to Support RECOVERY and Maintenance of FUNctional Abilities Among Seniors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Usability of the RecoveryFun system
研究概览
简要总结
The scope of the RecoveryFun study is to test a new personalised home rehabilitation solution to leverage the telehealth paradigm and increase the possibility for seniors to perform remotely supervised home-rehabilitation.
详细描述
This study was designed to test the usability and acceptability of the RecoveryFun system by a group of subjects, aged 60 years or older, within one year after an acute event with upper limb hemiplegia (Fugl- Meyer > 33). The patient, once the acute and intensive phase of rehabilitation is over, should also continue from home the process begun. However, this often creates difficulties for the patient. The study was carried out at the three recruitment sites (ZURZACH Care, TRAINM and INRCA)
The study was structured in two phases:
- A pilot in protected environment;
- A trial with the system used at the patient's home. The inclusion/exclusion criteria for the two steps were the same and the tools used to evaluate the result were the same too.
The two phases had different specific objectives and to avoid any bias due to previous experience the participants recruited in the two phases were different.
The RecoveryFun system comprehended Three tools: a Virtual reality headset for rehabilitation purposes, a set of Exergames and an app installed on caregiver's smartphone to motivate and support the end user in the therapy. The clinical personnel had access to the Clinical platform provided as a secured web app. The system administrator could differentiate access rights to each clinical user group (e.g: doctors, physiotherapists, nurses). An Innovative biosensing wireless sensor (wristband) was integrated in the connected ecosystem to measure physiological parameters (Heart Rate and Electrodermal Activity) of end users during the rehabilitation session. The patient performed the rehabilitation session according to the rehabilitation plan defined by the clinician. To have coherent results the rehabilitation plan included at least two weekly rehabilitation sessions lasting between 10 and 30 minutes, with the support of the caregiver, if necessary. Each session was planned and scheduled by the therapist remotely via the dedicated clinical platform.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No more than 12 months from acute event (for example stroke or brain injury)
- •Trunk Impairment Scale (TIS) ≥20
- •Fugl-Meyer Assessment Upper Extremities: Motor function for upper extremities (section A-D): a minimum Score of ≥33 is requested.
排除标准
- •Technical Requirements based on the safety manual of the "Pico" headset
- •Presence of pathology that could impact on the ability of using VR system or can be worsened by the use of VR system
- •Montreal Cognitive Assessment (MoCA) score <24
结局指标
主要结局
Usability of the RecoveryFun system
时间窗: after 4 weeks of home-rehabilitation with RecoveryFun system
The usability was assessed by the System Usability Scale (SUS). The SUS is a 10 item questionnaire with 5 response options.It generates a quantifiable measure called the SUS score, which ranges from 0 to 100, with zero being the least and 100 being the maximum.
Acceptability of the RecoveryFun system
时间窗: after 4 weeks of home-rehabilitation with RecoveryFun system
The acceptability was assessed by the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST). The QUEST is a 12-item outcome measure that assesses user satisfaction with two components, Device and Services. The questionnaire consists of 12 satisfaction items.
次要结局
未报告次要终点