Informations générales
  • Catégorie de maladie Maladies neurologiques (hors cancer) , Blessures , Maladies ostéomusculaires , Maladies du système nerveux (BASEC)
  • Study Phase N/A (ICTRP)
  • État du recrutement recrutement en cours (BASEC/ICTRP)
  • Lieu de l’étude
    Lugano, Autre
    (BASEC)
  • Responsable de l'étude Giada Devittori giada.devittori@hest.ethz.ch (BASEC)
  • Source(s) de données BASEC: Importé de 21.08.2025 ICTRP: Importé de 20.03.2025
  • Date de mise à jour 21.08.2025 18:01
HumRes66221 | SNCTP000006262 | BASEC2024-D0089 | NCT06725784

Feasibility and costs of robot-assisted hand rehabilitation

  • Catégorie de maladie Maladies neurologiques (hors cancer) , Blessures , Maladies ostéomusculaires , Maladies du système nerveux (BASEC)
  • Study Phase N/A (ICTRP)
  • État du recrutement recrutement en cours (BASEC/ICTRP)
  • Lieu de l’étude
    Lugano, Autre
    (BASEC)
  • Responsable de l'étude Giada Devittori giada.devittori@hest.ethz.ch (BASEC)
  • Source(s) de données BASEC: Importé de 21.08.2025 ICTRP: Importé de 20.03.2025
  • Date de mise à jour 21.08.2025 18:01

Résumé de l'étude

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)

Intervention étudiée

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)

Maladie en cours d'investigation

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

(BASEC)

Critères de participation
- 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)

Critères d'exclusion
- 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)

Lieu de l’étude

Lugano, Autre

(BASEC)

Brissago

(BASEC)

Switzerland (ICTRP)

Sponsor

Rehabilitation Engineering Laboratory, ETH Zurich

(BASEC)

Contact pour plus d'informations sur l'étude

Personne de contact en Suisse

Giada Devittori

0795314813

giada.devittori@hest.ethz.ch

Rehabilitation Engineering Laboratory, ETH Zurich

(BASEC)

Informations générales

0041445107234;0041917868633

giada.devittori@hest.ethz.ch

(ICTRP)

Informations générales

0041445107234

giada.devittori@hest.ethz.ch

(ICTRP)

Informations scientifiques

0041445107234;0041917868633

giada.devittori@hest.ethz.ch

(ICTRP)

Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Commission cantonale d'éthique du Tessin

(BASEC)

Date d'approbation du comité d'éthique

03.02.2025

(BASEC)


Identifiant de l'essai ICTRP
NCT06725784 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
Feasibility and cost of robot-assisted upper limb rehabilitation with different levels of supervision: an interventional study (BASEC)

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

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

Maladie en cours d'investigation
Upper Limb Sensorimotor Deficits (ICTRP)

Intervention étudiée
Device: ReHandyBot (ICTRP)

Type d'essai
Interventional (ICTRP)

Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). (ICTRP)

Critères d'inclusion/exclusion
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 disponible

Critères d'évaluation principaux et secondaires
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)

Date d'enregistrement
28.11.2024 (ICTRP)

Inclusion du premier participant
non disponible

Sponsors secondaires
Clinica Hildebrand Brissago (ICTRP)

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

ID secondaires
RHB Clinic (ICTRP)

Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06725784 (ICTRP)

Résultats de l'essai

Résumé des résultats

non disponible

Lien vers les résultats dans le registre primaire

non disponible