Feasibility and Cost of Robot-assisted Upper Limb Rehabilitation With Different Levels of Supervision: an Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Cost of ReHandyBot
研究概览
简要总结
Upper limb impairments are often a result of neurological or traumatic injuries (e.g., stroke, traumatic brain injuries). These impairments may decrease independence in performing activities of daily living, severely affecting patients' quality of life. Growing evidence shows that increasing upper limb therapy dose for patients could improve functional outcomes and prevent their long-term deterioration. However, due to limited resources (e.g., the number of therapists) and high rehabilitation-related costs, providing a higher therapy dose to patients is challenging, both in the clinic and after discharge, and finding new models of care is therefore critical.
Minimally supervised or unsupervised robot-assisted therapy (i.e., patients training with rehabilitation devices with minimal to no supervision of an external person) holds the promise of allowing an increase in therapy dose with little impact on the additional resources needed. Because of their ability to provide active support and measure a wide set of parameters, actuated (active) rehabilitation robots seem to be the best solution for this therapy setting. However, such devices are often complex to use and have never been extensively tested minimally or unsupervised. Consequently, the data available on their feasibility and cost-effectiveness is limited.
At the Rehabilitation Engineering Laboratory (RELab, ETH Zurich), we developed ReHandyBot, an actuated device for unsupervised upper limb therapy. The device has already been tested with stroke patients in an unsupervised setting, with positive results regarding usability and increase in therapy dose. The main goal of this project is, therefore, to investigate the feasibility and cost of our robot-assisted continuum of care model (i.e., from inpatient to ambulatory). Specifically, we aim to evaluate the feasibility of integrating ReHandyBot into the clinical routine and perform a preliminary cost-benefit analysis of supervised, minimally supervised, and unsupervised robot-assisted therapy. Furthermore, we will also gather data on the overall dose of robot-assisted therapy and the intensity of use of the device in a clinical and ambulatory setting.
详细描述
The ReHandyBot is a platform for hand rehabilitation with two degrees of freedom, namely forearm pronation/supination and finger flexion/extension. This device allows performing exercises targeting somatosensation and motor functions. Different exercises are implemented using virtual reality and haptic feedback; the interaction forces between subjects and ReHandyBot are measured by force sensors in the handles, allowing the control of a virtual hand and the physical interaction with the virtual environment. Mechanical properties (e.g., size, stiffness) of the objects displayed in the virtual environment are rendered by the motion/force of the instrumented handles. The type and difficulty level of the exercises are patient-specific and are automatically adapted throughout the therapy.
The duration and frequency of the therapy sessions with ReHandyBot depend on the specific patient's needs and are set according to the therapist's instructions.
The main goals of this study are to:
(i) Evaluate the feasibility of integrating ReHandyBot into the routine of rehabilitation clinics and ambulatories.
(ii) Perform a cost-benefit analysis of supervised, minimally supervised, and unsupervised therapy with the device.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent signed by the subject.
- •Female and male patients between 18 and 90 years old
- •Presence of an upper limb deficit derived from any disease or event that, according to the responsible clinicians, could be improved by therapy with ReHandyBot.
排除标准
- •Pathologies that may interfere with the training with ReHandyBot.
研究组 & 干预措施
ReHandyBot
The therapy sessions with ReHandyBot (e.g., frequency, duration) will be scheduled based on the therapist's instruction and may vary between patients, depending on their specific needs.
干预措施: ReHandyBot (Device)
结局指标
主要结局
Cost of ReHandyBot
时间窗: Monitored through study completion (expected duration: 5 years).
Manufacturing costs of ReHandyBot and cost of its maintenance over the duration of the study in Swiss Francs (CHF). These costs are monitored by the manufacturer.
Cost of the clinical staff supporting therapy with ReHandyBot
时间窗: Monitored through study completion (expected duration: 5 years).
Cost in Swiss Francs related to the clinical staff being present during the therapy sessions with ReHandyBot. This will be extrapolated from the software that the clinic uses to handle the schedules of the therapists. This cost is calculated by multiplying the number of therapy sessions with the device performed by the therapists of the clinic by the hourly rate of the therapists.
Number of supervised therapy sessions with ReHandyBot
时间窗: Monitored through study completion (expected duration: 5 years).
Number of therapy sessions with ReHandyBot performed by the participants under the supervision of a therapist (i.e., 1-to-1 therapy sessions). This number is extrapolated from the software that the clinic uses to handle the schedules of the patients.
Number of minimally supervised therapy sessions with ReHandyBot
时间窗: Monitored through study completion (expected duration: 5 years).
Number of therapy sessions with ReHandyBot performed by the participants under minimal supervision of a therapist (e.g., group sessions). This number is extrapolated from the software that the clinic uses to handle the schedules of the patients.
Number of unsupervised therapy sessions with ReHandyBot
时间窗: Monitored through study completion (expected duration: 5 years).
Number of therapy sessions with ReHandyBot performed by the participants without the supervision of a therapist (i.e., the therapist is not present). This number is extrapolated from the software that the clinic uses to handle the schedules of the patients.
Patient-to-therapist ratio of the therapy sessions with ReHandyBot
时间窗: Monitored through study completion (expected duration: 5 years).
Ratio of the number of patients to number of therapists present during the therapy sessions with ReHandyBot, where a higher ratio (i.e., multiple patients for one therapist) constitutes an economic benefit for the clinic. This ratio is extrapolated from the software of the clinic handling the schedules of patients and therapists.
次要结局
- Feasibility of integrating ReHandyBot into the routine of a rehabilitation clinic: adverse events(Monitored through study completion (expected duration: 5 years).)
- Feasibility of integrating ReHandyBot into the routine of a rehabilitation clinic: device deficiencies(Monitored through study completion (expected duration: 5 years).)
- Feasibility of integrating ReHandyBot into the routine of a rehabilitation clinic: usage(Monitored through study completion (expected duration: 5 years).)
- Intensity of use of ReHandyBot(Monitored through study completion (expected duration: 5 years).)
- Increase in therapy dose: minutes(From participant's recruitment (day 0) until discharge from the clinic (on average: after 4 weeks).)
- Increase in therapy dose: percentage(From participant's recruitment (day 0) until discharge from the clinic (on average: after 4 weeks).)
- Quantity of patients training with ReHandyBot(Monitored through study completion (expected duration: 5 years).)
- Characteristics of patients training with ReHandyBot(Monitored through study completion (expected duration: 5 years).)
- Reason why patients eventually stop training with ReHandyBot(From participant's recruitment (day 0) until the last session performed with the device (on average: 4 weeks).)
- Evolution of patient's satisfaction with robot-assisted therapy as assessed by a 5-point scale(Monitored over the whole protocol duration (i.e., from the first to the last therapy session with ReHandyBot, on average 4 weeks).)
- Usability as assessed by the System Usability Scale(Measured after two weeks from the first therapy session with ReHandyBot performed by a participant.)
- User experience - Net Promoter Score(Measured after two weeks from the first therapy session with ReHandyBot performed by a participant.)