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Upper Limb Sensorimotor DeficitsRHB ClinicNCT06725784

Feasibility and Cost of Robot-assisted Upper Limb Rehabilitation With Different Levels of Supervision

A study testing ReHandyBot in people with Upper Limb Sensorimotor Deficits, run by Swiss Federal Institute of Technology at 2 sites in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Upper Limb Sensorimotor Deficits
What is being tested?
ReHandyBot
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesSwitzerland
Study dates
4 Mar 2025to 30 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • 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.

Who cannot join

  • Pathologies that may interfere with the training with ReHandyBot.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Giada Devittori, Dr. contact

0041445107234

giada.devittori@hest.ethz.ch

Switzerland2 sites, 2 recruiting
  • Clinica Hildebrand Centro di riabilitazione Brissago

    Brissago, 6614

    Daria Dinacci, Dr. med., 0041917868633, d.dinacci@clinica-hildebrand.ch

    Recruiting
  • Clinica Hildebrand Centro Ambulatoriale Lugano

    Lugano

    Daria Dinacci, 0041 91 786 89 69, d.dinacci@clinica-hildebrand.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Feasibility and Cost of Robot-assisted Upper Limb Rehabilitation With Different Levels of Supervision: an Interventional Study

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.

Read the detailed description

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.

The secondary goals are to investigate:

(iii) The intensity of use of ReHandyBot by the facilities. (iv) The increase in therapy dose for the patients using the device minimally or unsupervised compared to usual care.

(v) The quantity and characteristics of patients who can train supervised, minimally, or unsupervised with the device.

(vi) Usability and user experience.

All the patients admitted to the clinic or ambulatory will be screened for participation in this study. Eligible patients will receive robot-assisted therapy sessions with the ReHandyBot in parallel to their conventional therapy program. During therapy with ReHandyBot, the patient sits comfortably on a chair in front of a screen and places the fingers of the impaired hand on the handles of the device.

The eligibility of the patients will be checked during the admission visit, after which, for eligible patients, a trial session with ReHandyBot will be scheduled. During the trial session, the supervising therapist will decide if the patient can really benefit from training with ReHandyBot, and if yes, the therapist will integrate supervised therapy sessions with the device into the therapy schedule of the patient. Then, during the supervised sessions, the therapist will use a checklist to decide if a patient can train minimally supervised (i.e., group sessions) or unsupervised. If this will be the case, the minimally or unsupervised therapy sessions will be added to the therapy schedule of the patient. 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. On the day of the last session with ReHandyBot, patients will fill in questionnaires to rate its usability and user experience.

For each recruited patient, data regarding demographics, medical condition, clinical and cognitive assessments, therapy dose, and device data will be recorded on the CRF. Medical and assessment data will be data routinely collected at the clinic and ambulatory. We will not perform evaluations specifically for this study.

At the end of the study, data regarding costs, intensity of use, and device retention will be recorded.

Being tested
ReHandyBot
Keywords
unsupervised therapy, robot-assisted rehabilitation, stroke, neurorehabilitation, orthopaedic rehabilitation, upper limb rehabilitation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ReHandyBotDevice

    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.

Study groups in NCT06725784
Study groupRoleWhat they receive
ReHandyBotExperimentalThe 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.
Receives: Device: ReHandyBot

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cost of ReHandyBot

    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.

    Measured: Monitored through study completion (expected duration: 5 years).

  2. Cost of the clinical staff supporting therapy with ReHandyBot

    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.

    Measured: Monitored through study completion (expected duration: 5 years).

  3. Number of supervised therapy sessions with ReHandyBot

    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.

    Measured: Monitored through study completion (expected duration: 5 years).

  4. Number of minimally supervised therapy sessions with ReHandyBot

    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.

    Measured: Monitored through study completion (expected duration: 5 years).

  5. Number of unsupervised therapy sessions with ReHandyBot

    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.

    Measured: Monitored through study completion (expected duration: 5 years).

  6. Patient-to-therapist ratio of the therapy sessions with ReHandyBot

    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.

    Measured: Monitored through study completion (expected duration: 5 years).

Secondary outcomes (12)
  1. Feasibility of integrating ReHandyBot into the routine of a rehabilitation clinic: adverse events

    Feasibility of integrating ReHandyBot into the routine of a rehabilitation clinic assessed as the number of adverse events related to the device.

    Measured: Monitored through study completion (expected duration: 5 years).

  2. Feasibility of integrating ReHandyBot into the routine of a rehabilitation clinic: device deficiencies

    Feasibility of integrating ReHandyBot into the routine of a rehabilitation clinic assessed as the number of device deficiencies.

    Measured: Monitored through study completion (expected duration: 5 years).

  3. Feasibility of integrating ReHandyBot into the routine of a rehabilitation clinic: usage

    Feasibility of integrating ReHandyBot into the routine of a rehabilitation clinic assessed as the usage (i.e., number of therapy sessions) of the device over time (i.e., if the device is no longer used after a short period, it means that it was not feasible to integrate it into the clinical routine of patients and therapists).

    Measured: Monitored through study completion (expected duration: 5 years).

  4. Intensity of use of ReHandyBot

    Intensity of use of ReHandyBot, assessed as the number of hours per day when the device is occupied by a patient.

    Measured: Monitored through study completion (expected duration: 5 years).

  5. Increase in therapy dose: minutes

    The increase in therapy dose in minutes for the patients using ReHandyBot minimally or unsupervised compared to usual care.

    Measured: From participant's recruitment (day 0) until discharge from the clinic (on average: after 4 weeks).

  6. Increase in therapy dose: percentage

    The increase in physical therapy dose in percentage for the patients using ReHandyBot minimally or unsupervised compared to usual care.

    Measured: From participant's recruitment (day 0) until discharge from the clinic (on average: after 4 weeks).

  7. Quantity of patients training with ReHandyBot

    Quantity of patients training with ReHandyBot expressed as the percentage of patients training with the device out of the total patients admitted to the clinic.

    Measured: Monitored through study completion (expected duration: 5 years).

  8. Characteristics of patients training with ReHandyBot

    Characteristics (e.g., age, diagnosis) of patients training with ReHandyBot compared to the patients who are not eligible or able to train with ReHandyBot.

    Measured: Monitored through study completion (expected duration: 5 years).

  9. Reason why patients eventually stop training with ReHandyBot

    Reason why an eligible patient eventually stops training with the device (e.g., due to not liking the device).

    Measured: From participant's recruitment (day 0) until the last session performed with the device (on average: 4 weeks).

  10. 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: Monitored over the whole protocol duration (i.e., from the first to the last therapy session with ReHandyBot, on average 4 weeks).

  11. Usability as assessed by the System Usability Scale

    Usability of the ReHandyBot measured with the System Usability Scale. The possible response options vary between 1 (strongly disagree) and 5 (strongly agree).

    Measured: Measured after two weeks from the first therapy session with ReHandyBot performed by a participant.

  12. User experience - Net Promoter Score

    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: Measured after two weeks from the first therapy session with ReHandyBot performed by a participant.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2024
  2. Study start4 Mar 2025
  3. Primary completion30 Dec 2030 (estimated)
  4. Study completion30 Dec 2030 (estimated)

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06725784
Sponsor's protocol ID
RHB Clinic
Acronym
RHB Clinic
Status last verified
Sep 2026
First submitted
28 Nov 2024
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ReHandyBot in people with Upper Limb Sensorimotor Deficits, run by Swiss Federal Institute of Technology at 2 sites 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 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 2 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Giada Devittori, Dr. (0041445107234, giada.devittori@hest.ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cost of ReHandyBot (time frame: Monitored through study completion (expected duration: 5 years).). The study lists 6 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 17 Sep 2026.

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