StrokeROBOHOMENCT07590349
Personalized Robotic Telerehabilitation for Upper Limb Functional Recovery After Stroke in a Home-Based Setting
A study testing Robotic-Assisted Telerehabilitation Virtual Reality-Based Telerehabilitation and Virtual reality-based rehabilitation platform without robotic assistance in people with Stroke and Hemiparesis, run by University of Campania Luigi Vanvitelli.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiparesis, Upper Extremity Paresis
- What is being tested?
- Robotic-Assisted Telerehabilitation Virtual Reality-Based Telerehabilitation and Virtual reality-based rehabilitation platform without robotic assistance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Stroke, Hemiparesis, Upper Extremity Paresis, Motor Impairment, Rehabilitation
- Being tested
- Robotic-Assisted Telerehabilitation Virtual Reality-Based Telerehabilitation, Virtual reality-based rehabilitation platform without robotic assistance
- Keywords
- stroke, Robotics, Telerehabilitation, Hemiplegia
- Medical subject headings
- Stroke, Paresis, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-Assisted Telerehabilitation Virtual Reality-Based TelerehabilitationDevice
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.
Virtual reality-based rehabilitation platform without robotic assistanceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-Assisted Telerehabilitation for Upper Limb Recovery | Experimental | 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. Receives: Device: Robotic-Assisted Telerehabilitation Virtual Reality-Based Telerehabilitation |
| Virtual Reality Telerehabilitation Without Robotic Support | Active comparator | 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. Receives: Other: Virtual reality-based rehabilitation platform without robotic assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 4 weeks
Secondary outcomes (9)
Box and Block Test (BBT)
Assessment of manual dexterity and upper-limb functional performance using the Box and Block Test.
Measured: Baseline to 4 weeks
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.
Measured: Baseline to 4 weeks
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.
Measured: Baseline to 4 weeks
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.
Measured: Baseline to 4 weeks
Muscle strength
Handgrip Strength Test (HST): Measurement of upper-limb muscle strength using handgrip dynamometry.
Measured: Baseline to 4 weeks
Patient satisfaction
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.
Measured: 4 weeks
Usability
System Usability Scale (SUS): Evaluation of system usability. A score ≥70 will be considered indicative of acceptable usability.
Measured: 4 weeks
Safety and tolerability
Incidence of adverse events: Assessment of safety based on the number and severity of adverse events related to the intervention
Measured: Throughout study (up to 4 weeks)
Treatment adherence and discontinuation
Drop-out rate: Proportion of participants who discontinue the intervention before completion.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Liguori, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590349
- Sponsor's protocol ID
- Prot. 0010201/i del 10/04/2026
- Acronym
- ROBOHOME
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data underlying the results will be shared with researchers upon reasonable request, following publication of the study results. Data will be de-identified in accordance with applicable data protection regulations.
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.
PubMed 21571152GBD 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.
PubMed 40335470
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Robotic Telerehabilitation for Upper Limb Functional Recovery After Stroke in a Home-Based Setting
- ClinicalTrials.gov ID
- NCT07590349
- Acronym / sponsor ID
- ROBOHOME / Prot. 0010201/i del 10/04/2026
- Conditions
- Stroke, Hemiparesis, Upper Extremity Paresis, Motor Impairment, Rehabilitation
- Keywords
- stroke, Robotics, Telerehabilitation, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Robotic-Assisted Telerehabilitation for Upper Limb Recovery | Experimental | Device: Robotic-Assisted Telerehabilitation Virtual Reality-Based TelerehabilitationParticipants 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. |
| Virtual Reality Telerehabilitation Without Robotic Support | Active comparator | Other: Virtual reality-based rehabilitation platform without robotic assistanceParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-Assisted Telerehabilitation Virtual Reality-Based TelerehabilitationExperimental: 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. | Device | Robotic-Assisted Telerehabilitation for Upper Limb Recovery |
| Virtual reality-based rehabilitation platform without robotic assistanceActive 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. | Other | Virtual Reality Telerehabilitation Without Robotic Support |
Primary outcome
Change in upper-limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time frame: 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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 21571152Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
- Background: PubMed 40335470GBD 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.
- Individual participant dataSharing planned: Yes. Individual participant data underlying the results will be shared with researchers upon reasonable request, following publication of the study results. Data will be de-identified in accordance with applicable data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-Assisted Telerehabilitation Virtual Reality-Based Telerehabilitation and Virtual reality-based rehabilitation platform without robotic assistance in people with Stroke and Hemiparesis, run by University of Campania Luigi Vanvitelli.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MARCO PAOLETTA, Researcher (+393922123028, marco.paoletta@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in upper-limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) (time frame: Baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07590349, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.