Allgemeine Informationen
  • Krankheitskategorie Hirnerkrankungen (nicht Krebs) , Verletzung , Muskel-Skelett-Erkrankungen (nicht Krebs) , Erkrankungen des Nervensystems (BASEC)
  • Studienphase N/A (ICTRP)
  • Rekrutierungsstatus Rekrutierung läuft (BASEC/ICTRP)
  • Studienstandort
    Lugano, Andere
    (BASEC)
  • Studienverantwortliche Giada Devittori giada.devittori@hest.ethz.ch (BASEC)
  • Datenquelle(n) BASEC: Import vom 21.08.2025 ICTRP: Import vom 20.03.2025
  • Letzte Aktualisierung 21.08.2025 18:01
HumRes66221 | SNCTP000006262 | BASEC2024-D0089 | NCT06725784

Feasibility and costs of robot-assisted hand rehabilitation

  • Krankheitskategorie Hirnerkrankungen (nicht Krebs) , Verletzung , Muskel-Skelett-Erkrankungen (nicht Krebs) , Erkrankungen des Nervensystems (BASEC)
  • Studienphase N/A (ICTRP)
  • Rekrutierungsstatus Rekrutierung läuft (BASEC/ICTRP)
  • Studienstandort
    Lugano, Andere
    (BASEC)
  • Studienverantwortliche Giada Devittori giada.devittori@hest.ethz.ch (BASEC)
  • Datenquelle(n) BASEC: Import vom 21.08.2025 ICTRP: Import vom 20.03.2025
  • Letzte Aktualisierung 21.08.2025 18:01

Zusammenfassung der Studie

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)

Untersuchte Intervention

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)

Untersuchte Krankheit(en)

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

(BASEC)

Kriterien zur Teilnahme
- 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)

Ausschlusskriterien
- 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)

Studienstandort

Lugano, Andere

(BASEC)

Brissago

(BASEC)

Switzerland (ICTRP)

Sponsor

Rehabilitation Engineering Laboratory, ETH Zurich

(BASEC)

Kontakt für weitere Auskünfte zur Studie

Kontaktperson Schweiz

Giada Devittori

0795314813

giada.devittori@hest.ethz.ch

Rehabilitation Engineering Laboratory, ETH Zurich

(BASEC)

Allgemeine Auskünfte

0041445107234;0041917868633

giada.devittori@hest.ethz.ch

(ICTRP)

Allgemeine Auskünfte

0041445107234

giada.devittori@hest.ethz.ch

(ICTRP)

Wissenschaftliche Auskünfte

0041445107234;0041917868633

giada.devittori@hest.ethz.ch

(ICTRP)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Tessin

(BASEC)

Datum der Bewilligung durch die Ethikkommission

03.02.2025

(BASEC)


ICTRP Studien-ID
NCT06725784 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
Feasibility and cost of robot-assisted upper limb rehabilitation with different levels of supervision: an interventional study (BASEC)

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

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

Untersuchte Krankheit(en)
Upper Limb Sensorimotor Deficits (ICTRP)

Untersuchte Intervention
Device: ReHandyBot (ICTRP)

Studientyp
Interventional (ICTRP)

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

Ein-/Ausschlusskriterien
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)

nicht verfügbar

Primäre und sekundäre Endpunkte
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)

Registrierungsdatum
28.11.2024 (ICTRP)

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
Clinica Hildebrand Brissago (ICTRP)

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

Sekundäre IDs
RHB Clinic (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06725784 (ICTRP)

Ergebnisse der Studie

Zusammenfassung der Ergebnisse

nicht verfügbar

Link zu den Ergebnissen im Primärregister

nicht verfügbar