Informazioni generali
  • Categoria della malattia Malattie cerebrali (non cancro) , Lesione / ferita , Malattie muscolo-scheletriche (non cancro) , Malattie del sistema nervoso (BASEC)
  • Fase dello studio N/A (ICTRP)
  • Stato di reclutamento reclutamento in corso (BASEC/ICTRP)
  • Luogo dello studio
    Lugano, Altro
    (BASEC)
  • Responsabile dello studio Giada Devittori giada.devittori@hest.ethz.ch (BASEC)
  • Fonte dati BASEC: Importato da 21.08.2025 ICTRP: Importato da 20.03.2025
  • Ultimo aggiornamento 21.08.2025 18:01
HumRes66221 | SNCTP000006262 | BASEC2024-D0089 | NCT06725784

Feasibility and costs of robot-assisted hand rehabilitation

  • Categoria della malattia Malattie cerebrali (non cancro) , Lesione / ferita , Malattie muscolo-scheletriche (non cancro) , Malattie del sistema nervoso (BASEC)
  • Fase dello studio N/A (ICTRP)
  • Stato di reclutamento reclutamento in corso (BASEC/ICTRP)
  • Luogo dello studio
    Lugano, Altro
    (BASEC)
  • Responsabile dello studio Giada Devittori giada.devittori@hest.ethz.ch (BASEC)
  • Fonte dati BASEC: Importato da 21.08.2025 ICTRP: Importato da 20.03.2025
  • Ultimo aggiornamento 21.08.2025 18:01

Descrizione riassuntiva dello studio

Deficits of the upper limb are often the result of neurological or traumatic injuries (e.g., stroke or traumatic brain injuries). These deficits can limit independence in performing activities of daily living, with serious repercussions on patients' quality of life. The literature shows that increasing the dose of therapy for the upper limb could further improve deficits and prevent long-term functional deterioration. However, due to limited resources (e.g., number of therapists) and high costs associated with rehabilitation, providing a higher dose of therapy to patients is challenging, both in the clinic and after discharge. Robot-assisted therapy with minimal or no supervision (i.e., patients training with rehabilitation devices with minimal or no supervision from an external person) could allow for an increase in therapy dose while minimally impacting the additional resources required. However, these robots are often complex to use and have never been thoroughly tested in minimally or non-supervised conditions. Consequently, the available data on their feasibility and costs are limited. At the Rehabilitation Engineering Laboratory (RELab, ETH Zurich), we developed ReHandyBot, a device for unsupervised therapy of the upper limb. The main objective of this project is to study the feasibility and costs of robot-assisted rehabilitation, from hospital admission to outpatient care. In particular, we want to assess the feasibility of integrating ReHandyBot into clinical routine and conduct a preliminary cost-benefit analysis of robotic therapy and the intensity of device use in clinical and outpatient settings.

(BASEC)

Intervento studiato

ReHandyBot is a hand rehabilitation device with two degrees of freedom, namely pronation/supination of the forearm and flexion/extension of the fingers. This device allows for targeted exercises aimed at the motor and sensory functions of the upper limb. Various exercises are implemented using virtual reality and haptic feedback. The type and level of difficulty of the exercises are patient-specific and are automatically adjusted during therapy. Therapy with ReHandyBot is integrated into the patients' therapy program. The robot is initially used under the supervision of a therapist. Subsequently, if possible, patients can use the robot during semi-supervised group therapy sessions monitored by therapists or without supervision. The number of therapy sessions with ReHandyBot is determined by the therapists based on the needs of the individual patient. During each session, the robot proposes a series of 3 exercises, each lasting between 10 and 15 minutes.

(BASEC)

Malattie studiate

Deficits of the upper limbs (i.e., hand and/or arm).

(BASEC)

Criteri di partecipazione
- The patient has read, understood, and signed the informed consent. - Age between 18 and 90 years. - Presence of an upper limb deficit due to any disease or event that, according to clinical staff, could improve with therapy using ReHandyBot. (BASEC)

Criteri di esclusione
- Inability to remain seated for 30 minutes straight. - Acute inflammatory musculoskeletal conditions of the upper limb. - The patient is not alert, not cooperative, unable to follow a command and/or unable to give consent (based on the assessment of the specialized interdisciplinary team during the intake visit). (BASEC)

Luogo dello studio

Lugano, Altro

(BASEC)

Brissago

(BASEC)

Switzerland (ICTRP)

Sponsor

Rehabilitation Engineering Laboratory, ETH Zurich

(BASEC)

Contatto per ulteriori informazioni sullo studio

Persona di contatto in Svizzera

Giada Devittori

0795314813

giada.devittori@hest.ethz.ch

Rehabilitation Engineering Laboratory, ETH Zurich

(BASEC)

Informazioni generali

0041445107234;0041917868633

giada.devittori@hest.ethz.ch

(ICTRP)

Informazioni generali

0041445107234

giada.devittori@hest.ethz.ch

(ICTRP)

Informazioni scientifiche

0041445107234;0041917868633

giada.devittori@hest.ethz.ch

(ICTRP)

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione d'etica Ticino

(BASEC)

Data di approvazione del comitato etico

03.02.2025

(BASEC)


ID di studio ICTRP
NCT06725784 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Feasibility and cost of robot-assisted upper limb rehabilitation with different levels of supervision: an interventional study (BASEC)

Titolo accademico
Feasibility and Cost of Robot-assisted Upper Limb Rehabilitation with Different Levels of Supervision: an Interventional Study (ICTRP)

Titolo pubblico
Feasibility and Cost of Robot-assisted Upper Limb Rehabilitation with Different Levels of Supervision (ICTRP)

Malattie studiate
Upper Limb Sensorimotor Deficits (ICTRP)

Intervento studiato
Device: ReHandyBot (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
Inclusion Criteria:

- 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.

Exclusion Criteria:

- Pathologies that may interfere with the training with ReHandyBot. (ICTRP)

non disponibile

Endpoint primari e secondari
Cost of ReHandyBot;Cost of the clinical staff supporting therapy with ReHandyBot;Number of supervised therapy sessions with ReHandyBot;Number of minimally supervised therapy sessions with ReHandyBot;Number of unsupervised therapy sessions with ReHandyBot;Patient-to-therapist ratio of the therapy sessions with ReHandyBot (ICTRP)

Quantity of patients training with ReHandyBot;Characteristics of patients training with ReHandyBot;Reason why patients eventually stop training with ReHandyBot;Evolution of patient's satisfaction with robot-assisted therapy as assessed by a 5-point scale;Feasibility of integrating ReHandyBot into the routine of a rehabilitation clinic: adverse events;Feasibility of integrating ReHandyBot into the routine of a rehabilitation clinic: device deficiencies;Feasibility of integrating ReHandyBot into the routine of a rehabilitation clinic: usage;Intensity of use of ReHandyBot;Increase in therapy dose: minutes;Increase in therapy dose: percentage;Usability as assessed by the System Usability Scale;User experience - Net Promoter Score (ICTRP)

Data di registrazione
28.11.2024 (ICTRP)

Inclusione del primo partecipante
non disponibile

Sponsor secondari
Clinica Hildebrand Brissago (ICTRP)

Contatti aggiuntivi
Giada Devittori, Dr.;Daria Dinacci, Dr. med., giada.devittori@hest.ethz.ch; d.dinacci@clinica-hildebrand.ch, 0041445107234;0041917868633 (ICTRP)

ID secondari
RHB Clinic (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06725784 (ICTRP)

Risultati dello studio

Riepilogo dei risultati

non disponibile

Link ai risultati nel registro primario

non disponibile