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Personalized Robotic Telerehabilitation for Upper Limb Functional Recovery After Stroke in a Home-Based Setting (ROBOHOME)

14 mai 2026 mis à jour par: Sara Liguori, University of Campania Luigi Vanvitelli

Stroke is a leading cause of long-term disability worldwide, with upper-limb impairment representing a major determinant of functional limitation and reduced independence. Conventional rehabilitation approaches are often limited by accessibility, intensity, and long-term adherence, highlighting the need for innovative, home-based solutions.

This study aims to evaluate the effectiveness of a personalized robotic telerehabilitation program for upper-limb recovery in individuals with post-stroke motor impairment. The intervention combines a wearable robotic device with a virtual reality-based platform, enabling patients to perform structured, task-oriented exercises in a home environment under remote supervision.

Participants will be allocated to either a robotic-assisted telerehabilitation program or a control condition based on virtual reality-based rehabilitation alone. Motor recovery will be assessed using standardized clinical scales, including the Fugl-Meyer Assessment for Upper Extremity (FMA-UE), along with measures of functional performance, patient-reported outcomes, and treatment adherence.

By integrating robotic assistance with telemedicine, this study seeks to enhance rehabilitation intensity, improve patient engagement, and facilitate continuity of care beyond traditional clinical settings. The results are expected to support the development of accessible, personalized rehabilitation pathways for individuals with stroke-related upper-limb disability.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

This multicenter, prospective, randomized controlled trial aims to evaluate the effectiveness of a personalized telerehabilitation protocol integrating a wearable robotic device with a virtual reality (VR)-based platform in individuals with post-stroke upper-limb impairment.

Stroke-related upper-limb dysfunction significantly affects daily activities, social participation, and quality of life. According to the International Classification of Functioning, Disability and Health (ICF), participation is a key outcome; however, upper-limb disability represents a major barrier to inclusion.

Robotic rehabilitation and advanced technologies have demonstrated clinical effectiveness in improving motor function. However, their use is mainly limited to specialized centers. Home-based telerehabilitation enables continuity of care, enhances treatment intensity, and supports long-term recovery, while reducing the need for in-person sessions.

The intervention combines:

a wearable robotic device (EMOVO), a virtual reality telerehabilitation platform (VRRS Home Kit).

Participants will undergo a structured 4-week rehabilitation program consisting of daily 60-minute sessions administered at home and remotely supervised by rehabilitation professionals.

Participants will be randomized into:

an experimental group receiving robotic-assisted telerehabilitation, a control group receiving VR-based telerehabilitation alone.

The study will evaluate motor recovery, functional performance, patient-reported outcomes, treatment adherence, user satisfaction, and safety.

Type d'étude

Interventionnel

Inscription (Estimé)

70

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Adults aged 18 years or older
  • Diagnosis of stroke with residual upper-limb motor impairment
  • Upper-limb functional impairment defined by a Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 20 and 50
  • Ability to understand study procedures and provide written informed consent
  • Availability of a home environment suitable for telerehabilitation

Exclusion Criteria:

  • Presence of severe neurological or musculoskeletal disorders affecting the upper limb
  • Severe spasticity (Modified Ashworth Scale ≥3)
  • Severe upper-limb pain (Numerical Rating Scale >4)
  • Skin lesions, infections, or conditions preventing safe use of wearable devices
  • Participation in another interventional clinical trial
  • Any medical or cognitive condition that may interfere with compliance or safe participation in the study

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Robotic-Assisted Telerehabilitation for Upper Limb Recovery
Participants assigned to this arm will receive a home-based telerehabilitation program supported by a wearable robotic device integrated with a virtual reality-based rehabilitation platform. The intervention consists of daily 60-minute sessions over a 4-week period and includes passive and active-assisted upper-limb mobilization, grasping and releasing exercises, task-oriented activities, and interactive exergaming exercises. All sessions will be remotely supervised by a physiotherapist, with individualized adjustments based on participant performance and progression.
Dispositif: Robotic-Assisted Telerehabilitation Virtual Reality-Based Telerehabilitation
Experimental: Robotic-Assisted Telerehabilitation for Upper Limb Recovery Arm Description: Participants assigned to the experimental group will receive a home-based telerehabilitation program supported by a wearable robotic device integrated with a virtual reality-based rehabilitation platform. The intervention consists of daily 60-minute sessions over a 4-week period, including passive and active-assisted upper-limb mobilization, task-oriented exercises, and exergaming activities, with remote supervision by a physiotherapist.
Comparateur actif: Virtual Reality Telerehabilitation Without Robotic Support
Participants assigned to this arm will receive a home-based telerehabilitation program delivered through a virtual reality-based rehabilitation platform. The intervention consists of daily 60-minute sessions over a 4-week period and includes upper-limb mobilization exercises, task-oriented training, and interactive exergaming activities. All sessions will be remotely supervised by a physiotherapist to ensure correct execution and adherence to the rehabilitation protocol.
Autre: Virtual reality-based rehabilitation platform without robotic assistance
Active Comparator: Virtual Reality Telerehabilitation Without Robotic Support Arm Description: Participants assigned to the control group will receive a home-based telerehabilitation program delivered through a virtual reality-based rehabilitation platform. The intervention consists of daily 60-minute sessions over a 4-week period, including upper-limb mobilization exercises, task-oriented training, and interactive exergaming activities. All sessions will be remotely supervised by a physiotherapist to ensure correct execution and adherence to the protocol.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in upper-limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Délai: Baseline to 4 weeks
The primary outcome is the change in upper-limb motor function measured using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE), comparing baseline (pre-intervention) and post-treatment values. The FMA-UE is a validated, stroke-specific scale that evaluates motor recovery and functional impairment of the upper limb.
Baseline to 4 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Box and Block Test (BBT)
Délai: Baseline to 4 weeks
Assessment of manual dexterity and upper-limb functional performance using the Box and Block Test.
Baseline to 4 weeks
Functional independence
Délai: Baseline to 4 weeks
Barthel Index (BI): Assessment of functional independence in activities of daily living using the Barthel Index. The Barthel Index is a standardized scale ranging from 0 to 100, where higher scores indicate greater functional independence.
Baseline to 4 weeks
Pain intensity and interference
Délai: Baseline to 4 weeks
Brief Pain Inventory (BPI): Assessment of pain severity and pain-related interference with daily activities using the Brief Pain Inventory. The BPI is a standardized scale with scores ranging from 0 to 10, where higher scores indicate greater pain intensity and greater interference with daily activities.
Baseline to 4 weeks
Stroke-related quality of life
Délai: Baseline to 4 weeks
Stroke Impact Scale (SIS): Evaluation of stroke-related quality of life across physical, emotional, and social domains using the Stroke Impact Scale. The SIS is a standardized patient-reported outcome measure with domain scores ranging from 0 to 100, where higher scores indicate better quality of life and functional status.
Baseline to 4 weeks
Muscle strength
Délai: Baseline to 4 weeks
Handgrip Strength Test (HST): Measurement of upper-limb muscle strength using handgrip dynamometry.
Baseline to 4 weeks
Patient satisfaction
Délai: 4 weeks
Assessment of user satisfaction with assistive technology and system integration using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0). The QUEST 2.0 is a standardized questionnaire with item scores ranging from 1 to 5, where higher scores indicate greater user satisfaction. Clinically meaningful satisfaction is defined as a mean score ≥4.
4 weeks
Usability
Délai: 4 weeks
System Usability Scale (SUS): Evaluation of system usability. A score ≥70 will be considered indicative of acceptable usability.
4 weeks
Safety and tolerability
Délai: Throughout study (up to 4 weeks)
Incidence of adverse events: Assessment of safety based on the number and severity of adverse events related to the intervention
Throughout study (up to 4 weeks)
Treatment adherence and discontinuation
Délai: 4 weeks
Drop-out rate: Proportion of participants who discontinue the intervention before completion.
4 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Campania Luigi Vanvitelli

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

30 mai 2027

Achèvement de l'étude (Estimé)

30 mai 2027

Dates d'inscription aux études

Première soumission

8 mai 2026

Première soumission répondant aux critères de contrôle qualité

14 mai 2026

Première publication (Réel)

15 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Prot. 0010201/i del 10/04/2026

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Individual participant data underlying the results will be shared with researchers upon reasonable request, following publication of the study results. Data will be de-identified in accordance with applicable data protection regulations.

Délai de partage IPD

Starting 6 months after publication of the primary results; ending 5 years after publication.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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