Feasibility of Unsupervised Therapy After Neurological or Orthopaedical Injury in the Home Setting With a Hand Rehabilitation Device (ReHandyBot) and an Assistive Smartphone Application (RehabCoach): an Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Dose of unsupervised therapy - Minutes
研究概览
简要总结
The goal of this clinical trial is to evaluate whether using the ReHandyBot hand rehabilitation device together with the RehabCoach smartphone app can support safe, independent, and effective home therapy in patients with stroke, traumatic brain injury, or orthopedic problems.
The main questions it aims to answer are:
- Can patients safely and independently use ReHandyBot and RehabCoach after leaving the clinic?
- Will patients follow the recommended daily therapy schedule when using these tools at home?
- How do patients experience the usability and acceptability of ReHandyBot and RehabCoach in everyday life?
- Can this type of home-based therapy be extended to populations beyond stroke, such as traumatic brain injury and orthopedic patients?
Participants will:
- Complete a screening and baseline assessment with a therapist.
- Use ReHandyBot in a supervised phase at the clinic (3 sessions of 30 minutes).
- Continue with a minimally supervised phase at the clinic (3-7 sessions of 30 minutes, with daily app use).
- If ready, enter the unsupervised phase, taking ReHandyBot home for daily 30-minute training sessions, supported by RehabCoach.
- Return for a final assessment including clinical and robotic evaluations and usability feedback.
详细描述
Many neurological (e.g., stroke, traumatic brain injury) and orthopedic patients do not fully recover hand function, with a consequent decrease in independence and quality of life. Growing evidence shows that increasing the dose of upper limb therapy for in- and outpatients could improve functional outcomes. However, due to limited resources such as the low number of therapists, providing a higher dose of therapy to patients after discharge is highly challenging.
Unsupervised technology-assisted therapy, i.e., patients training with rehabilitation technologies without external supervision or intervention, may allow an increase in therapy dose (in clinical settings and at home) with little impact on the additional resources needed.
At the Rehabilitation Engineering Laboratory (RELab, ETH Zurich) we developed ReHandyBot, a portable device for hand rehabilitation. ReHandyBot was developed for unsupervised application in the home setting and preliminary results of an ongoing study show that stroke patients can learn how to use the device independently and bring it home to keep training with it after discharge from the clinic, increasing their therapy dose. However, during the unsupervised phase at home, patients' adherence to the recommended dose of therapy with ReHandyBot (i.e., at least one therapy session per day) was not always optimal.
At home, without the supervision of healthcare providers, patients often experience a decline in motivation and engagement over time. To address this, we developed RehabCoach, a smartphone application designed to support unsupervised therapy with ReHandyBot. RehabCoach incorporates chatbots (i.e., conversations with virtual assistants) and gamification elements designed to enhance therapy adherence. Until now, RehabCoach has been tested in some pilot usability studies, but a more extended evaluation has not been performed yet.
This study, therefore, investigates the use of ReHandyBot supported by RehabCoach at the homes of patients with stroke, traumatic brain injury, or orthopedic issues. The main objectives of this study are therefore to investigate (i) the feasibility of unsupervised therapy with ReHandyBot and RehabCoach within patients' home after discharge from the clinic, (ii) compliance to the therapy schedule after discharge, (iii) the usability of ReHandyBot and RehabCoach and user experience when using them, and (iv) the feasibility of extending therapy with ReHandyBot to populations other than stroke (i.e., patients with orthopedic problems or traumatic brain injury).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility criteria for neurological patients
- •Inclusion criteria:
- •Informed Consent signed by the subject.
- •Female and male patients between 18 and 90 years old.
- •Stroke or traumatic brain injury (recruitment within 6 months from event onset).
- •Presence of a motor and/or sensory impairment of the upper limb as assessed by the responsible therapist.
- •Possibility (e.g., enough space) to set up the ReHandyBot at home.
排除标准
- •Modified Ashworth Scale > 2 for one or more of the following muscles: shoulder adductors, forearm pronator and supinator, flexors and extensors of elbow, wrist and fingers.
- •Moderate to severe aphasia: Goodglass-Kaplan's scale <
- •Moderate to severe cognitive deficits: levels of cognitive functioning-revised (LCF-R) <
- •Functional impairment of the upper limb due to other pathologies.
- •Severe pain in the affected arm: visual analogue scale for pain (VASp) ≥
- •Other pathologies which may interfere with the study.
- •After discharge, the patient will go to an assisted living facility (e.g., care home).
- •Eligibility criteria for orthopedic patients
- •Inclusion criteria:
- •Informed Consent signed by the subject.
- •Female and male patients between 18 and 90 years old.
- •Clinic stay due to an orthopedic-related condition (e.g., surgery, trauma, burns).
- •Presence of a motor and/or sensory impairment of the upper limb as assessed by the responsible therapist.
- •Possibility (e.g., enough space) to set up the ReHandyBot at home.
- •Exclusion criteria:
- •Moderate to severe aphasia: Goodglass-Kaplan's scale <
- •Moderate to severe cognitive deficits: levels of cognitive functioning-revised (LCF-R) <
- •Functional impairment of the upper limb due to other pathologies.
- •Severe pain in the affected arm: visual analogue scale for pain (VASp) ≥
- •Other pathologies which may interfere with the study.
- •After discharge, the patient will go to an assisted living facility (e.g., care home).
结局指标
主要结局
Dose of unsupervised therapy - Minutes
时间窗: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).
Dose in minutes of self-administered robot-assisted therapy performed by subjects in the home setting without supervision.
Dose of unsupervised therapy - Repetitions
时间窗: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).
Daily dose in number of task repetitions of self-administered robot-assisted therapy performed by subjects in the home setting without supervision.
Dose of unsupervised therapy - Percentual change in therapy time
时间窗: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).
Percentage increase in therapy time due to the unsupervised robotic therapy compared to the case where the participants would perform conventional (i.e., normally prescribed) therapy only.
次要结局
- Usability as assessed by the raw NASA Task Load Index (2)(Usability is measured again at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).)
- Feasibility - Adverse events(This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).)
- Feasibility - Device deficiencies(This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).)
- Feasibility - App deficiencies(This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).)
- Feasibility - Number of subjects performing unsupervised robot-assisted training(This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).)
- Feasibility - Attendance(This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).)
- Usability as assessed by the System Usability Scale (1)(This is measured during the intervention (at the end of the familiarization phase, before the 6 weeks unsupervised at home start).)
- Usability as assessed by the System Usability Scale (2)(Usability is measured again at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).)
- Usability as assessed by the raw NASA Task Load Index (1)(This is measured during the intervention (at the end of the familiarization phase, before the 6 weeks unsupervised at home start).)
- Usability as assessed by the mHealth App Usability Questionnaire (MAUQ) for RehabCoach (1)(This is measured during the intervention (at the end of the familiarization phase, before the start of the 6 weeks unsupervised at home).)
- Usability as assessed by the Chatbot Usability Questionnaire (1)(This is measured during the intervention (at the end of the familiarization phase, before the start of the 6 weeks unsupervised at home).)
- Technology acceptance as assessed by the Technology Acceptance Model(This will be measured at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).)
- User experience - Net Promoter Score - ReHandyBot (1)(This is measured during the intervention (at the end of the familiarization phase, right before the start of the 6 weeks unsupervised at home).)
- Change in the user experience metrics - RehabCoach (i.e., Customer Satisfaction Score and Net Promoter Score)(This is calculated at the end of the study (i.e., at the end of the six weeks of unsupervised therapy at home).)
- Smartphone usage and familiarity with texting apps as assessed by two custom questions(This is assessed after the familiarization period, before the 6-weeks intervention starts.)
- Engagement as assessed by number of educational sessions completed(Recorded throughout the intervention period, measured at the end of the 6-weeks intervention.)
- Motivation as assessed by therapy session adherence and initiation(Measured at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).)
- Change in upper limb functions as assessed by the ABILHAND(This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).)
- Change in upper limb functions as assessed by the Box and Block (BBT) test(This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).)
- Change in Upper Limb Function as Assessed by the Box and Block Test (BBT)(Measured at baseline and at the end of the study protocol (after six weeks of unsupervised therapy at home).)
- Change in the active Range of Motion (aROM) for grasping measured in millimeters as assessed by the custom robotic assessment "aROM - Hand"(This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).)
- Change in proprioception as assessed by the custom robotic assessment "JND" measuring the minimum difference in length (mm) and/or angle (degrees) that a patient can perceive(This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).)
- Usability as assessed by the mHealth App Usability Questionnaire (MAUQ) for RehabCoach (2)(This is measured again at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).)
- User experience - Customer Satisfaction Score - ReHandyBot (1)(This is measured during the intervention (at the end of the familiarization phase, right before the start of the 6 weeks unsupervised at home).)
- User experience - Net Promoter Score - ReHandyBot (2)(User experience is measured again at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).)
- User experience - Customer Satisfaction Score - RehabCoach (1)(This is measured during the intervention (at the end of the familiarization phase, right before the start of the 6 weeks unsupervised at home).)
- User experience - Customer Satisfaction Score - RehabCoach (2)(User experience is measured again at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).)
- User experience - Net Promoter Score - RehabCoach (1)(This is measured during the intervention (at the end of the familiarization phase, right before the start of the 6 weeks unsupervised at home).)
- Usability as assessed by the Chatbot Usability Questionnaire (2)(This is is measured again at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).)
- Evolution of patient's satisfaction with robot-assisted therapy as assessed by a 5-point scale(This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).)
- Change in usability metrics between familiarization and end of study(This is calculated at the end of the study (i.e., at the end of the six weeks of unsupervised therapy at home).)
- User experience - Customer Satisfaction Score - ReHandyBot (2)(User experience is measured again at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).)
- Therapeutic alliance as assessed by the Session Alliance Questionnaire(Every day during the 6 weeks unsupervised at home intervention period.)
- Educational material knowledge retention as assessed by quiz performance(This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).)
- Change in Sensory Function as Assessed by the Erasmus MC Modification to the Revised Nottingham Sensory Assessment (EmNSA)(Measured at baseline and at the end of the study protocol (after six weeks of unsupervised therapy at home).)
- Change in haptic perception as assessed by the custom robotic assessment "Weber Fraction" measuring the minimum difference in stiffness that a patient can perceive in percentage(This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).)
- Content of robotic therapy - Intensity(This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).)
- Change in the user experience metrics - ReHandyBot (i.e., Customer Satisfaction Score and Net Promoter Score)(This is calculated at the end of the study (i.e., at the end of the six weeks of unsupervised therapy at home).)
- Reasons for Missing Therapy Sessions(This is calculated at the end of the study (i.e., at the end of the six weeks of unsupervised therapy at home).)
- User experience - Net Promoter Score - RehabCoach (2)(User experience is measured again at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).)
- Qualitative analysis of conversational data with RehabCoach chatbots(This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).)
- Change in the active Range of Motion (aROM) for forearm rotation measured in degrees as assessed by the custom robotic assessment "aROM - Forearm"(This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).)
- Content of robotic therapy - Performance(This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).)
- Content of robotic therapy - Effective time ratio(This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).)
- Parameters influencing unsupervised robot-assisted therapy(This is calculated at the end of the study (i.e., at the end of the six weeks of unsupervised therapy at home).)