Stroke
Conditions
Keywords
Stroke, Hand impairment, Robot-assisted therapy, Unsupervised therapy, Neurorehabilitation
Brief summary
The ReHandyBot (RHB) is a robot for hand rehabilitation after stroke. The aims of this study are to investigate (i) the generalizability of unsupervised therapy with the ReHandyBot within patients' home after discharge from a clinic, (ii) compliance, as measured by the amount of unsupervised robot-assisted therapy dose (e.g., therapy time) performed by the subjects after discharge, (iii) the usability of ReHandyBot and user experience during robot-assisted therapy, and (iv) the effect of the increase in therapy dose achieved with our device compared to standard care. The study consists of two primary phases. The first is a familiarization phase conducted at the clinic, where therapists teach participants how to perform the exercises using the robot. Then, if capable of training with the robot safely, after discharge from the clinic, participants can bring the robot home and autonomously train with it. The hypothesis is that unsupervised therapy might be a possible way to increase therapy dose for stroke patients, with the potential to further improve recovery of hand function, with minimal additional burden for therapists and for the healthcare system.
Interventions
DEVICESupervised and minimally supervised therapy with ReHandyBot
During the familiarization phase at the rehabilitation clinics, participants perform one week of supervised and one week of minimally supervised therapy with the ReHandyBot under the supervision of a supervisor (i.e., therapist or researcher). Minimally supervised therapy means that participants try to perform therapy with the device themselves, while the supervisor is still present but helps only if participants encounter problems or have questions. During the supervised and minimally supervised phases (first 2 weeks), the intervention consists of 5 sessions of approximately 30 minutes each per week. These sessions are performed in addition to the conventional therapy plan. During each session, the robot proposes a set of different exercises targeting the upper limb.
DEVICEUnsupervised therapy
After the familiarization phase, participants train without supervision at the clinic until discharge and then at home for six weeks. If the therapist thinks that the participant has properly learned how to use the device and can train with it safely, the participant can keep training with the device unsupervised (both at the clinic and at home). If participants are not ready for unsupervised therapy with the device, they stop the study at the end of the familiarization phase.
Sponsors
Swiss Federal Institute of Technology
Kliniken Valens
Rehaklinik Bellikon
Rehaklinik Zihlschlacht AG
University Hospital, Geneva
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Informed Consent signed by the subject; * female and male patients between 18 and 90 years old; * acute/subacute stroke (recruitment within 12 weeks from stroke onset); * pre-stroke modified Rankin score ≤ 1; * National Institutes of Health Stroke Scale (NIHSS) ≥ 1 in at least one of the items regarding motor functions, sensory functions and ataxia; * possibility (e.g., enough space) to set up the ReHandyBot at home.
Exclusion criteria
* 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 \< 3; * moderate to severe cognitive deficits: levels of cognitive functioning-revised (LCF-R) \< 9; * functional impairment of the upper limb due to other pathologies; * severe pain in the affected arm: visual analogue scale for pain (VASp) ≥ 5; * other pathologies which may interfere with the study; * after discharge the patient will go to an assisted living facility (e.g., care home).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose of unsupervised therapy - Minutes | This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home). | Daily dose in minutes of self-administered robot-assisted therapy performed by subjects in the home setting without supervision. |
| Dose of unsupervised therapy - Repetitions | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 of therapy with the ReHandyBot as assessed by the number of adverse events occurring during this study. |
| 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 of therapy with the ReHandyBot as assessed by the number of device deficiencies occurring during this study. |
| Feasibility - Subjects performing unsupervised robot-assisted training | This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit). | Feasibility of unsupervised therapy with the ReHandyBot as assessed by the number of subjects who can transition to unsupervised robot-assisted therapy at home out of the total number of tested subjects. |
| Feasibility - Attendance | This is calculated on completion of the study protocol, i.e., at the end of the six weeks of unsupervised therapy at home. | Feasibility of unsupervised therapy with the ReHandyBot as assessed by attendance during the unsupervised phase at home. Attendance is measured as the percentage of days where the subject trains at least once without supervision out of the 42 days offered for unsupervised training at home. |
| Generalizability of unsupervised therapy with the ReHandyBot | This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit). | Generalizability is assessed by comparing the feasibility of the intervention across the four sites. |
| Usability as assessed by the System Usability Scale (1) | This is measured at the end of the second week of intervention (at the end of the familiarization phase). | Usability of the ReHandyBot measured with the System Usability Scale. The possible response options vary between 1 (strongly disagree) and 5 (strongly agree). |
| Usability as assessed by the System Usability Scale (2) | Usability is measured again after 8 weeks of intervention. | Usability of the ReHandyBot measured with the System Usability Scale. The possible response options vary between 1 (strongly disagree) and 5 (strongly agree). |
| Usability as assessed by the raw NASA Task Load Index (1) | This is measured at the end of the second week of intervention (at the end of the familiarization phase). | Usability of the ReHandyBot measured with the raw NASA (National Aeronautics and Space Administration) Task Load Index. Answers range from 0 (low task load) to 100 (high task load). |
| Usability as assessed by the raw NASA Task Load Index (2) | Usability is measured again after 8 weeks of intervention. | Usability of the ReHandyBot measured with the raw NASA (National Aeronautics and Space Administration) Task Load Index. Answers range from 0 (low task load) to 100 (high task load). |
| Usability as assessed by the Post-Study System Usability Questionnaire (1) | This is measured at the end of the second week of intervention (at the end of the familiarization phase). | Usability of the ReHandyBot measured with the Post-Study System Usability Questionnaire (version 3). This questionnaire consists of 16 questions and the possible response options vary between 1 (strongly agree) and 7 (strongly disagree). |
| Usability as assessed by the Post-Study System Usability Questionnaire (2) | Usability is measured again after 8 weeks of intervention. | Usability of the ReHandyBot measured with the Post-Study System Usability Questionnaire (version 3). This questionnaire consists of 16 questions and the possible response options vary between 1 (strongly agree) and 7 (strongly disagree). |
| 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). | A 5-point scale is presented by the robot at the end of each therapy session to measure patient's satisfaction with robot-assisted therapy. The scale ranges from 1 (low satisfaction) to 5 (high satisfaction). |
| Usability - Intrinsic Motivation Inventory (1) | This is measured at the end of the second week of intervention (at the end of the familiarization phase). | Usability of the gaming environment is measured with the Intrinsic Motivation Inventory (items: Interest/Enjoyment). The possible response options vary between 1 (not true at all) and 7 (completely true). |
| Usability - Intrinsic Motivation Inventory (2) | User experience is measured again after 8 weeks of intervention. | Usability of the gaming environment is measured with the Intrinsic Motivation Inventory (items: Interest/Enjoyment). The possible response options vary between 1 (not true at all) and 7 (completely true). |
| Change in usability | This is calculated at the end of the study (i.e., after 8 weeks of intervention). | Change in usability between the first and second time when it is measured. This change is used to define how the absence of the therapist during robot-assisted therapy impacts the perceived usability of the device. |
| User experience - Customer Satisfaction Score (1) | This is measured at the end of the second week of intervention (at the end of the familiarization phase). | The Customer Satisfaction Score consists of the question "Overall, how satisfied are you with the therapy with ReHandyBot?". The possible response options vary between 1 (extremely dissatisfied) and 5 (extremely satisfied). |
| User experience - Customer Satisfaction Score (2) | User experience is measured again after 8 weeks of intervention. | The Customer Satisfaction Score consists of the question "Overall, how satisfied are you with the therapy with ReHandyBot?". The possible response options vary between 1 (extremely dissatisfied) and 5 (extremely satisfied). |
| User experience - Net Promoter Score (1) | This is measured at the end of the second week of intervention (at the end of the familiarization phase). | The Net Promoter Score consists of the question "How likely would you be to recommend therapy with ReHandyBot to another patient?". The possible response options vary between 1 (extremely unlikely) and 10 (extremely likely). |
| User experience - Net Promoter Score (2) | User experience is measured again after 8 weeks of intervention. | The Net Promoter Score consists of the question "How likely would you be to recommend therapy with ReHandyBot to another patient?". The possible response options vary between 1 (extremely unlikely) and 10 (extremely likely). |
| Change in the user experience | This is calculated at the end of the study (i.e., after 8 weeks of intervention). | Change in user experience between the first and second time when it is measured. This change is used to define how the absence of the therapist during robot assisted therapy impacts user experience when training with the device. |
| Change in upper limb functions as assessed by the Fugl-Meyer Assessment of Upper Extremities (FMA-UE) | 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 between midterm (i.e., at discharge from the clinic) and final (i.e., end of the study) upper limb functions as assessed by the FMA-UE. |
| 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 between midterm (i.e., at discharge from the clinic) and final (i.e. end of the study) upper limb functions as assessed by the ABILHAND scale. |
| 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 between midterm (i.e., at discharge from the clinic) and final (i.e. end of the study) upper limb functions as assessed by the BBT test. |
| Change in upper limb functions as assessed by the modified Ashworth Scale (mAS) | 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 between midterm (i.e., at discharge from the clinic) and final (i.e., end of the study) upper limb functions as assessed by the mAS. |
| 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 between baseline (i.e. beginning of the study) and final (i.e. end of the study) aROM for grasping, i.e. for hand opening and closing. This is measured by the robot with a custom assessment. |
| Change in proprioception as assessed by the custom robotic assessment "JND" measuring the minimum difference in hand positioning that a patient can perceive | This is calculated at the end of the study, after performing the final measurements (i.e., after 8 weeks of intervention). | Change between baseline (i.e. beginning of the study) and final (i.e. end of the study) proprioception, defined as the minimum difference in the hand position that a patient can perceive (i.e. just noticeable difference). This is measured by the robot with a custom assessment. |
| 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). | Change between baseline (i.e. beginning of the study) and final (i.e. end of the study) haptic perception, defined as the minimum difference in stiffness that a patient can perceive expressed in percentage according to the Weber Fraction law . This is measured by the robot with a custom assessment named "Weber fraction". |
| Content of robotic therapy - Intensity (repetitions of a therapy task over time) | 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). | Intensity (i.e., repetitions of a therapy task over time) of the robotic therapy throughout the study. |
| 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). | Task performance (i.e., correct trials over total trials) during robotic therapy throughout the study. |
| 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). | Ratio of effective (i.e., net total therapy time without breaks) over total duration of the therapy session during robotic therapy throughout the study. |
| 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). | Correlation between achieved unsupervised robot-assisted therapy dose and different parameters (i.e., cognitive assessments (Goodglass-Kaplan Scale, LCF-R, Montreal Cognitive Assessment (MoCA)) performed during the screening visit, the clinical assessments, the robotic assessments, demographics and the collected medical data). |
Countries
Switzerland
Contacts
CONTACTGiada Devittori, Dr.
PRINCIPAL_INVESTIGATORBertrand Léger, Dr.
Responsible for research at the SUVA clinics (Bellikon and Sion)
PRINCIPAL_INVESTIGATORRoman Gonzenbach, Dr. med. Dr. sc. nat.
Rehaklinik Valens
PRINCIPAL_INVESTIGATORRené Müri, Prof. Dr. med.
Rehaklinik Zihlschlacht AG
PRINCIPAL_INVESTIGATORMauro Silva, Dr. med.
University Hospital, Geneva
Outcome results
None listed