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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. 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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Switzerland
Clinica Hildebrand Centro di riabilitazione Brissago
RECRUITING
Brissago
Clinica Hildebrand Centro Ambulatoriale Lugano
RECRUITING
Lugano
Contact Information
Primary
Giada Devittori, Dr.
giada.devittori@hest.ethz.ch
0041445107234
Time Frame
Start Date: 2025-03-04
Estimated Completion Date: 2030-12-30
Participants
Target number of participants: 100
Treatments
Experimental: ReHandyBot
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.
Related Therapeutic Areas
Sponsors
Collaborators: Clinica Hildebrand Brissago
Leads: Swiss Federal Institute of Technology

This content was sourced from clinicaltrials.gov