Personalized Robotic Telerehabilitation for Upper Limb Functional Recovery After Stroke in a Home-Based Setting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robotic-Assisted Telerehabilitation Virtual Reality-Based Telerehabilitation, Virtual reality-based rehabilitation platform without robotic assistance.
- Who it may be relevant to
- Registry conditions: Stroke, Hemiparesis, Upper Extremity Paresis, Motor Impairment. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device 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 s - Other 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 physiotherap
Primary outcome measures
- Change in upper-limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) [Time frame: Baseline to 4 weeks]
Secondary outcome measures (9)
- Box and Block Test (BBT) [Time frame: Baseline to 4 weeks]
- Functional independence [Time frame: Baseline to 4 weeks]
- Pain intensity and interference [Time frame: Baseline to 4 weeks]
- Stroke-related quality of life [Time frame: Baseline to 4 weeks]
- Muscle strength [Time frame: Baseline to 4 weeks]
- Patient satisfaction [Time frame: 4 weeks]
- Usability [Time frame: 4 weeks]
- Safety and tolerability [Time frame: Throughout study (up to 4 weeks)]
- Treatment adherence and discontinuation [Time frame: 4 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5. PMID 21571152
- 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. PMID 40335470
Identifiers
NCT: NCT07590349 · Prot. 0010201/i del 10/04/2026