Hemiparesis, Motor Impairment, Rehabilitation, Stroke, Upper Extremity Paresis
Conditions
Keywords
stroke, Robotics, Telerehabilitation, Hemiplegia
Brief summary
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.
Detailed description
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.
Interventions
DEVICERobotic-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.
OTHERVirtual 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.
Sponsors
University of Campania Luigi Vanvitelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This study is designed as an open-label trial with no masking. Due to the nature of the interventions, participants and study personnel (including therapists and investigators) cannot be blinded to group allocation. Participants in the experimental group will use a wearable robotic device integrated with a virtual reality-based telerehabilitation platform, while participants in the control group will receive virtual reality-based telerehabilitation alone. The clear differences between interventions make blinding unfeasible. Outcome assessments will be based on standardized clinical scales and objective measures to minimize potential assessment bias.
Intervention model description
Participants will be randomized to either robotic-assisted telerehabilitation or virtual reality-based telerehabilitation alone in a parallel-group design. Both interventions will be delivered in a home-based setting with remote supervision over 4 weeks to compare their effects on upper-limb recovery after stroke.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in upper-limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke-related quality of life | 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. |
| Muscle strength | Baseline to 4 weeks | Handgrip Strength Test (HST): Measurement of upper-limb muscle strength using handgrip dynamometry. |
| Patient satisfaction | 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. |
| Usability | 4 weeks | System Usability Scale (SUS): Evaluation of system usability. A score ≥70 will be considered indicative of acceptable usability. |
| Safety and tolerability | 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 |
| Treatment adherence and discontinuation | 4 weeks | Drop-out rate: Proportion of participants who discontinue the intervention before completion. |
| Functional independence | 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. |
| Pain intensity and interference | 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. |
| Box and Block Test (BBT) | Baseline to 4 weeks | Assessment of manual dexterity and upper-limb functional performance using the Box and Block Test. |
Contacts
CONTACTMARCO PAOLETTA, Researcher
Outcome results
None listed