Feasibility - Adverse events
Feasibility of therapy with the ReHandyBot as assessed by the number of adverse events occurring during this study.
Feasibility - Device deficiencies
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
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
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 14 days offered for unsupervised training at home.
Usability as assessed by the System Usability Scale (1)
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 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)
Usability of the ReHandyBot measured with the raw NASA Task Load Index.
Usability as assessed by the raw NASA Task Load Index (2)
Usability of the ReHandyBot measured with the raw NASA Task Load Index.
Usability as assessed by the Post-Study System Usability Questionnaire (1)
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 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
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.
Usability - Intrinsic Motivation Inventory (1)
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)
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 metrics (i.e., System Usability Scale, NASA Task Load Index, Post-Study System Usability Questionnaire, and Intrinsic Motivation Inventory)
Change in the metrics (i.e., System Usability Scale, NASA Task Load Index, Post-Study System Usability Questionnaire, and Intrinsic Motivation Inventory) used to assess usability between the first and second time when they are 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)
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)
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)
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)
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 metrics (i.e., Customer Satisfaction Score and Net Promoter Score)
Change in the metrics used to assess user experience (i.e., Customer Satisfaction Score and Net Promoter Score) between the first and second time when they are 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)
Change between baseline (i.e. beginning of the study) 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
Change between baseline (i.e. beginning of the study) 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
Change between baseline (i.e. beginning of the study) 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 Motor Evaluation Scale for Upper Extremities in Stroke Patients (MESUPES)
Change between baseline (i.e. beginning of the study) and final (i.e. end of the study) upper limb functions as assessed by the MESUPES. The scores can vary between 0 and 58, and a higher score means a better outcome.
Change in upper limb functions as assessed by the modified Ashworth Scale (mAS)
Change between baseline (i.e. beginning of the study) 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"
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 the active Range of Motion (aROM) for forearm rotation measured in degrees as assessed by the custom robotic assessment "aROM - Forearm"
Change between baseline (i.e. beginning of the study) and final (i.e. end of the study) aROM for forearm pronation and supination. 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 length (mm) and/or angle (degrees) that a patient can perceive
Change between baseline (i.e. beginning of the study) and final (i.e. end of the study) proprioception, defined as the minimum difference in length and/or angle 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
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
Intensity (i.e., repetitions over time) of the robotic therapy throughout the study.
Content of robotic therapy - Performance
Task performance (i.e., correct trials over total trials) during robotic therapy throughout the study.
Content of robotic therapy - Effective time ratio
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
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).