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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorSwiss Federal Institute of Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pathologies that may interfere with the training with ReHandyBot.

Trial design

Design model

Single group

Treatments tested in this trial

  • ReHandyBot

    Device

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: ReHandyBotExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

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

Secondary outcomes

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.

Time frame
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.

Time frame
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).

Time frame
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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Swiss Federal Institute of Technology

Lead sponsor

Clinica Hildebrand Brissago

Collaborator