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

NCT06725784 | Recruiting

• 1 other identifier: RHB Clinic
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Upper Limb Sensorimotor Deficits

Keywords

unsupervised therapy; robot-assisted rehabilitation; stroke; neurorehabilitation; orthopaedic rehabilitation; upper limb rehabilitation

Outcome Measures

Primary Outcomes (6)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (12)

• Feasibility of integrating ReHandyBot into the routine of a rehabilitation clinic: adverse events

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

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

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

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

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

• Intensity of use of ReHandyBot

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

• Increase in therapy dose: minutes

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

Study Arms (1)

ReHandyBot

EXPERIMENTAL

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.

Device: ReHandyBot

Interventions

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.

ReHandyBot

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pathologies that may interfere with the training with ReHandyBot.

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Clinica Hildebrand Brissago: collaborator

Study Sites (2)

Clinica Hildebrand Centro di riabilitazione Brissago

Brissago, 6614, Switzerland

RECRUITING

Clinica Hildebrand Centro Ambulatoriale Lugano

Lugano, Switzerland

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Giada Devittori, Dr.

CONTACT

0041445107234; giada.devittori@hest.ethz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 10, 2024
• Study Start: March 4, 2025
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)