Personalized Robotic Telerehabilitation for Upper Limb Functional Recovery After Stroke in a Home-Based Setting

NCT07590349 | Not Yet Recruiting

• 1 other identifier: Prot. 0010201/i del 10/04/2026
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke; Hemiparesis; Upper Extremity Paresis; Motor Impairment; Rehabilitation

Keywords

stroke; Robotics; Telerehabilitation; Hemiplegia

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 4 weeks

Secondary Outcomes (9)

• Box and Block Test (BBT)

  Baseline to 4 weeks

• Functional independence

  Baseline to 4 weeks

• Pain intensity and interference

  Baseline to 4 weeks

• Stroke-related quality of life

  Baseline to 4 weeks

• Muscle strength

  Baseline to 4 weeks

Study Arms (2)

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.

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.

Other: Virtual reality-based rehabilitation platform without robotic assistance

Interventions

Robotic-Assisted Telerehabilitation Virtual Reality-Based Telerehabilitation DEVICE

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.

Robotic-Assisted Telerehabilitation for Upper Limb Recovery

Virtual reality-based rehabilitation platform without robotic assistance OTHER

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.

Virtual Reality Telerehabilitation Without Robotic Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Stroke; Paresis; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Central Study Contacts

MARCO PAOLETTA, Researcher

CONTACT

+393922123028; marco.paoletta@unicampania.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication of the primary results; ending 5 years after publication.