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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: MARCO PAOLETTA, Researcher
- Telefonní číslo: +393922123028
- E-mail: marco.paoletta@unicampania.it
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
|
|
Aktivní komparátor: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in upper-limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Box and Block Test (BBT)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline to 4 weeks
|
Handgrip Strength Test (HST): Measurement of upper-limb muscle strength using handgrip dynamometry.
|
Baseline to 4 weeks
|
|
Patient satisfaction
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 4 weeks
|
Drop-out rate: Proportion of participants who discontinue the intervention before completion.
|
4 weeks
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Prot. 0010201/i del 10/04/2026
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