Personalized Robotic Telerehabilitation for Upper Limb Functional Recovery After Stroke in a Home-Based Setting (ROBOHOME)
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: MARCO PAOLETTA, Researcher
- Número de teléfono: +393922123028
- Correo electrónico: marco.paoletta@unicampania.it
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
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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.
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|
Comparador activo: 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.
|
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in upper-limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Box and Block Test (BBT)
Periodo de tiempo: Baseline to 4 weeks
|
Assessment of manual dexterity and upper-limb functional performance using the Box and Block Test.
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Baseline to 4 weeks
|
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Functional independence
Periodo de tiempo: Baseline to 4 weeks
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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
Periodo de tiempo: 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
|
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Stroke-related quality of life
Periodo de tiempo: 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
|
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Muscle strength
Periodo de tiempo: Baseline to 4 weeks
|
Handgrip Strength Test (HST): Measurement of upper-limb muscle strength using handgrip dynamometry.
|
Baseline to 4 weeks
|
|
Patient satisfaction
Periodo de tiempo: 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
Periodo de tiempo: 4 weeks
|
System Usability Scale (SUS): Evaluation of system usability.
A score ≥70 will be considered indicative of acceptable usability.
|
4 weeks
|
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Safety and tolerability
Periodo de tiempo: Throughout study (up to 4 weeks)
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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)
|
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Treatment adherence and discontinuation
Periodo de tiempo: 4 weeks
|
Drop-out rate: Proportion of participants who discontinue the intervention before completion.
|
4 weeks
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
- GBD 2019 Acute and Chronic Care Collaborators. Characterising acute and chronic care needs: insights from the Global Burden of Disease Study 2019. Nat Commun. 2025 May 7;16(1):4235. doi: 10.1038/s41467-025-56910-x.
Fechas de registro del estudio
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Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Parálisis
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Carrera
- Paresia
- Hemiplejía
Otros números de identificación del estudio
- Prot. 0010201/i del 10/04/2026
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
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- PROTOCOLO DE ESTUDIO
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