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.
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
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
Parallel
Robotic-Assisted Telerehabilitation Virtual Reality-Based Telerehabilitation
DeviceExperimental: 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.
Virtual reality-based rehabilitation platform without robotic assistance
Other interventionActive 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.
Change in upper-limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
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.
Box and Block Test (BBT)
Assessment of manual dexterity and upper-limb functional performance using the Box and Block Test.
Functional independence
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.
Pain intensity and interference
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.
Stroke-related quality of life
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.
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