StrokeNCT06057129
Unsupervised Therapy After Stroke in the Home Setting With a Hand Rehabilitation Device (ReHandyBot)
A study testing Supervised and minimally-supervised therapy with ReHandyBot and Unsupervised therapy in people with Stroke, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
The ReHandyBot is a robot for hand rehabilitation after stroke. The aims of this study are (1) to investigate the feasibility of unsupervised therapy with the ReHandyBot with stroke inpatients, first in a rehabilitation clinic and then at participants' home, (2) to evaluate the usability of the ReHandyBot (user… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Supervised and minimally-supervised therapy with ReHandyBot and Unsupervised therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Nov 2023to 29 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- pacemakers and other active implants;
- after discharge the patient will go to an assisted living facility (e.g., care home).
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinica Hildebrand Centro di riabiliazione Brissago
Brissago, Canton Ticino, 6614
About this study
Official title: Feasibility of Unsupervised Therapy After Stroke in the Home Setting With a Hand Rehabilitation Device (ReHandyBot): an Exploratory Study
The ReHandyBot is a robot for hand rehabilitation after stroke. The aims of this study are (1) to investigate the feasibility of unsupervised therapy with the ReHandyBot with stroke inpatients, first in a rehabilitation clinic and then at participants' home, (2) to evaluate the usability of the ReHandyBot (user interface, implemented exercises, and gaming environment, which were adapted for independent usage), and (3) to quantify the dose of additional robotic therapy that patients perform without supervision.
The study consists of two primary phases. The first is a familiarization phase performed at the clinic, where therapists teach to the participants how to perform the exercises with 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.
- Conditions
- Stroke
- Being tested
- Supervised and minimally-supervised therapy with ReHandyBot, Unsupervised therapy
- Keywords
- Stroke, Hand impairment, Robot-assisted therapy, Unsupervised therapy, Neurorehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised and minimally-supervised therapy with ReHandyBotDevice
Also called Familiarization phase
During the familiarization phase at the rehabilitation clinic, 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 by themselves, while the supervisor is still present but helps only in case participants encounter problems or if they have any questions. During the supervised and minimally-supervised phases (first 2 weeks), the intervention dose is 5 sessions of approximately 45 minutes per week. These sessions are performed in addition to the conventional therapy plan. During each session, the robot proposes a set of 3 exercises, each lasting between 10 and 15 minutes.
Unsupervised therapyDevice
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 have properly learnt 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 receive a booklet of exercises to perform without supervision (both at the clinic and at home). These exercises do not imply the use of the robot but are exercises discussed with the therapists and meaningful for the specific patient.
| Study group | Role | What they receive |
|---|---|---|
| Unsupervised therapy | Experimental | This group will perform therapy with the ReHandyBot first with the supervision of a therapist at the rehabilitation clinic. Then, after discharge, if the participant learnt how to safely train with the device, they can bring the device home and train with it unsupervised. On the other hand, if participants are not capable of training without supervision, after discharge they perform unsupervised therapy at home with a booklet of exercises (i.e., without the robot). Receives: Device: Supervised and minimally-supervised therapy with ReHandyBot; Device: Unsupervised therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of unsupervised therapy - Minutes
Daily dose in minutes of self-administered robot-assisted therapy performed by subjects in the home setting without supervision.
Measured: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).
Dose of unsupervised therapy - Repetitions
Daily dose in number of task repetitions of self-administered robot-assisted therapy performed by subjects in the home setting without supervision.
Measured: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).
Dose of unsupervised therapy - Percentual change in therapy time
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.
Measured: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).
Secondary outcomes (32)
Feasibility - Adverse events
Feasibility of therapy with the ReHandyBot as assessed by the number of adverse events occurring during this study.
Measured: 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
Feasibility of therapy with the ReHandyBot as assessed by the number of device deficiencies occurring during this study.
Measured: 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 - 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.
Measured: This is calculated on completion of the study (i.e., right after last subject - last visit).
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 42 days offered for unsupervised training at home.
Measured: This is calculated on completion of the study protocol.
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).
Measured: This is measured during the intervention (at the end of the familiarization phase).
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).
Measured: 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)
Usability of the ReHandyBot measured with the raw NASA Task Load Index.
Measured: This is measured during the intervention (at the end of the familiarization phase).
Usability as assessed by the raw NASA Task Load Index (2)
Usability of the ReHandyBot measured with the raw NASA Task Load Index.
Measured: 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 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).
Measured: This is measured during the intervention (at the end of the familiarization phase).
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).
Measured: 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).
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.
Measured: 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).
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).
Measured: This is measured during the intervention (at the end of the familiarization phase).
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).
Measured: 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).
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.
Measured: 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 (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).
Measured: This is measured during the intervention (at the end of the familiarization phase).
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).
Measured: 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 (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).
Measured: This is measured during the intervention (at the end of the familiarization phase).
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).
Measured: 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).
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.
Measured: This is calculated at the end of the study (i.e., at the end of the six weeks of unsupervised therapy at home).
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.
Measured: 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 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.
Measured: 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
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.
Measured: 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: 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"
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.
Measured: 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
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.
Measured: 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 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".
Measured: 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
Intensity (i.e., repetitions over time) of the robotic therapy throughout the study.
Measured: 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 - Performance
Task performance (i.e., correct trials over total trials) during robotic therapy throughout the study.
Measured: 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
Ratio of effective (i.e., net total therapy time without breaks) over total duration of the therapy session during robotic therapy throughout the study.
Measured: 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
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).
Measured: This is calculated at the end of the study (i.e., at the end of the six weeks of unsupervised therapy at home).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start13 Nov 2023
- Primary completion29 May 2026
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Clinica Hildebrand Brissago
- Responsible party
- Sponsor
- Investigators
- Paolo Rossi, Dr. med., Principal investigator, Clinica Hildebrand Brissago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057129
- Sponsor's protocol ID
- RHB Home
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Unsupervised Therapy After Stroke in the Home Setting With a Hand Rehabilitation Device (ReHandyBot): an Exploratory Study
- ClinicalTrials.gov ID
- NCT06057129
- Acronym / sponsor ID
- RHB Home
- Conditions
- Stroke
- Keywords
- Stroke, Hand impairment, Robot-assisted therapy, Unsupervised therapy, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Clinica Hildebrand Brissago
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ReHandyBot is a robot for hand rehabilitation after stroke. The aims of this study are (1) to investigate the feasibility of unsupervised therapy with the ReHandyBot with stroke inpatients, first in a rehabilitation clinic and then at participants' home, (2) to evaluate the usability of the ReHandyBot (user interface, implemented exercises, and gaming environment, which were adapted for independent usage), and (3) to quantify the dose of additional robotic therapy that patients perform without supervision.
The study consists of two primary phases. The first is a familiarization phase performed at the clinic, where therapists teach to the participants how to perform the exercises with 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unsupervised therapy | Experimental | Device: Supervised and minimally-supervised therapy with ReHandyBot, Device: Unsupervised therapyThis group will perform therapy with the ReHandyBot first with the supervision of a therapist at the rehabilitation clinic. Then, after discharge, if the participant learnt how to safely train with the device, they can bring the device home and train with it unsupervised. On the other hand, if participants are not capable of training without supervision, after discharge they perform unsupervised therapy at home with a booklet of exercises (i.e., without the robot). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised and minimally-supervised therapy with ReHandyBotAlso: Familiarization phaseDuring the familiarization phase at the rehabilitation clinic, 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 by themselves, while the supervisor is still present but helps only in case participants encounter problems or if they have any questions. During the supervised and minimally-supervised phases (first 2 weeks), the intervention dose is 5 sessions of approximately 45 minutes per week. These sessions are performed in addition to the conventional therapy plan. During each session, the robot proposes a set of 3 exercises, each lasting between 10 and 15 minutes. | Device | Unsupervised therapy |
| Unsupervised therapyAfter 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 have properly learnt 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 receive a booklet of exercises to perform without supervision (both at the clinic and at home). These exercises do not imply the use of the robot but are exercises discussed with the therapists and meaningful for the specific patient. | Device | Unsupervised therapy |
Primary outcome
Dose of unsupervised therapy - Minutes
Time frame: 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
Time frame: 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
Time frame: 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.
32 secondary outcomes
Feasibility - Adverse events
Time frame: 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
Time frame: 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 - Subjects performing unsupervised robot-assisted training
Time frame: This is calculated on completion of the study (i.e., right after last subject - last visit).
Feasibility - Attendance
Time frame: This is calculated on completion of the study protocol.
Usability as assessed by the System Usability Scale (1)
Time frame: This is measured during the intervention (at the end of the familiarization phase).
Usability as assessed by the System Usability Scale (2)
Time frame: 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)
Time frame: This is measured during the intervention (at the end of the familiarization phase).
Usability as assessed by the raw NASA Task Load Index (2)
Time frame: 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 Post-Study System Usability Questionnaire (1)
Time frame: This is measured during the intervention (at the end of the familiarization phase).
Usability as assessed by the Post-Study System Usability Questionnaire (2)
Time frame: 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).
Evolution of patient's satisfaction with robot-assisted therapy as assessed by a 5-point scale
Time frame: 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).
Usability - Intrinsic Motivation Inventory (1)
Time frame: This is measured during the intervention (at the end of the familiarization phase).
Usability - Intrinsic Motivation Inventory (2)
Time frame: 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).
Change in usability metrics (i.e., System Usability Scale, NASA Task Load Index, Post-Study System Usability Questionnaire, and Intrinsic Motivation Inventory)
Time frame: 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 (1)
Time frame: This is measured during the intervention (at the end of the familiarization phase).
User experience - Customer Satisfaction Score (2)
Time frame: 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 (1)
Time frame: This is measured during the intervention (at the end of the familiarization phase).
User experience - Net Promoter Score (2)
Time frame: 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).
Change in the user experience metrics (i.e., Customer Satisfaction Score and Net Promoter Score)
Time frame: This is calculated at the end of the study (i.e., at the end of the six weeks of unsupervised therapy at home).
Change in upper limb functions as assessed by the Fugl-Meyer Assessment of Upper Extremities (FMA-UE)
Time frame: 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 ABILHAND
Time frame: 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
Time frame: 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 Motor Evaluation Scale for Upper Extremities in Stroke Patients (MESUPES)
Time frame: 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 modified Ashworth Scale (mAS)
Time frame: 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 grasping measured in millimeters as assessed by the custom robotic assessment "aROM - Hand"
Time frame: 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"
Time frame: 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
Time frame: 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 haptic perception as assessed by the custom robotic assessment "Weber Fraction" measuring the minimum difference in stiffness that a patient can perceive in percentage
Time frame: 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
Time frame: 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 - Performance
Time frame: 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
Time frame: 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
Time frame: This is calculated at the end of the study (i.e., at the end of the six weeks of unsupervised therapy at home).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Rossi, Dr. med. principal investigator
Clinica Hildebrand Brissago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised and minimally-supervised therapy with ReHandyBot and Unsupervised therapy in people with Stroke, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of unsupervised therapy - Minutes (time frame: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.