Robotic Rehabilitation of the Upper Limb in Subacute Stroke (GLORIA)

April 20, 2026 updated by: IRCCS San Raffaele Roma

Efficacy of Robotic Rehabilitation for Neuro Recovery of the Upper Limb in Subacute Stroke Survivors: An International Multicenter Randomized Controlled Trial

This multicenter international randomized controlled trial (RCT) evaluates the effectiveness of the Gloreha Sinfonia® robotic exoskeleton for upper limb rehabilitation in individuals with subacute post-stroke paresis. The study aims to determine whether robotic-assisted therapy improves voluntary motor control and coordination more effectively than conventional rehabilitation, as measured by the Fugl-Meyer Assessment (FMA) for the upper limb (motor component).

Participants will be randomly assigned to one of two groups:

  • Experimental Group (EG): Robotic-assisted upper limb rehabilitation combined with conventional therapy.
  • Control Group (CG): Conventional therapy alone including upper limb rehabilitation.

Clinical assessments will be conducted at baseline (T1), post-treatment (T2), and at a 3-month follow-up (T3) using remotely administered scales.

Secondary objectives include evaluating improvements in muscle strength, range of motion, eye-hand coordination, manual dexterity, and functional independence. The study will also assess prognostic factors influencing response to robotic therapy, patient satisfaction, and potential adverse events.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke is a leading cause of disability worldwide, with hemiparesis impairing upper limb function in 75% of affected patients. This deficit significantly reduces patients' independence in activities of daily living (ADLs) and limits social participation. Recovery of upper limb motor function is a primary goal in post-stroke rehabilitation. In recent years, robotic devices for hand rehabilitation have been introduced. The Gloreha Sinfonia® (R-Touch Pro, BTL Robotics) is a robotic exoskeleton that enables repetitive, intensive movements in passive, assisted, and active modes. Despite growing evidence supporting robotics in upper limb rehabilitation, significant gaps remain, including the lack of standardized protocols and the challenge of identifying patient subgroups that would benefit most. This multicenter international RCT aims to address these gaps by evaluating the short- and long-term effectiveness of robot-assisted therapy compared to conventional therapy. The primary objective is to measure the efficacy of robotic rehabilitation using the Fugl-Meyer Motor Assessment (0-66) for the upper limb, a validated scale assessing improvements in strength, active range of motion, eye-hand coordination, and dexterity. This outcome allows for a direct connection between robotic therapy results and motor function, ensuring a precise and replicable evaluation of treatment efficacy relative to conventional therapy. It is hypothesized that robotic treatment with Gloreha Sinfonia R-Touch Pro will significantly improve strength, active range of motion, eye-hand coordination, and manual dexterity, while also promoting autonomy in ADLs and social participation. The study also aims to identify clinical and prognostic factors that influence the response to robotic therapy, assess patient acceptance and satisfaction with the treatment, and monitor for any adverse events. Specifically, secondary objectives of the study are: to assess the impact of robotic treatment on muscle strength, active range of motion, hand-eye coordination, fine motor skills, and dexterity; to examine the effect of treatment on independence in daily living activities and social participation.

Identify clinical characteristics, such as severity of neurological impairment and time from acute event, that best respond to robot-assisted hand therapy; to investigate the influence of treatment initiation timing in relation to the acute event on rehabilitation effectiveness; to assess patient acceptance and satisfaction with the treatment, monitor the occurrence of adverse events, and analyze the effect of treatment on upper limb spasticity. Participants with a stroke diagnosis who meet the inclusion and exclusion criteria will be randomly assigned to one of the following groups: Experimental Group (EG) - robotic treatment for upper limb rehabilitation using the GS robotic device or Control Group (CG) - conventional treatment for upper limb rehabilitation. The study will span 36 months and includes two phases as follows: Phase 1 - Recruitment, baseline evaluations, randomization, rehabilitation intervention, final evaluations, and Phase 2 - Follow-up.

Eligible patients will be randomized into one of two treatment groups (Phase 1): EG or CG. All subjects will be evaluated (Phase 1) with a series of clinical assessments at baseline (T1) and the same assessments will be repeated at the end of the treatment (T2). A 3-month follow-up (Phase 2, T3) will be conducted either through an in-person clinical assessment or a phone interview, based on patient availability, using only remote-administered clinical scales. As for the rehabilitation treatments, the Experimental Group (EG) will receive upper limb rehabilitation assisted by the Gloreha Sinfonia R-Touch Pro device, in addition to conventional therapy, which includes physical therapy (PT) and occupational therapy (OT) and the Control Group (CG) will undergo the same upper limb rehabilitation with only conventional PT and OT treatments, matching the EG's duration for a total of 90 minutes. Both groups will engage in individualized rehabilitation programs, potentially incorporating additional personalized interventions based on each patient's clinical-neurological profile. Randomization will be conducted in a blind manner by an independent collaborator who is not involved in recruitment, intervention, or data collection. Sequentially numbered, opaque, and randomly ordered envelopes containing group assignments will be opened after the initial evaluation, in the participant's presence. Therapists involved will be informed of each patient's group assignment. All data will be collected in compliance with privacy regulations and anonymized on a dedicated platform called RedCAP (Research Electronic Data Capture) https://redcap.sanraffaele.it/. Each center will have access to its own data, with the ability to independently modify and update it. Data will be recorded through the Clinical Report Form (CRF), ensuring systematic and standardized data collection. Descriptive statistical analysis will be performed to adequately represent the clinical and demographic characteristics of the sample, with data presented as frequency (percentage), mean and standard deviation, and median (5th and 95th percentile) for categorical, continuous, and ordinal variables, respectively. Descriptive statistics will ensure score comparability between groups at baseline; an inferential analysis of variables (Kolmogorov-Smirnov test) will be conducted to verify the normality of data distributions. Parametric or non-parametric tests will be applied based on data distribution. The significance level will be set at p<0.05.

In conclusion, the main expected results are: to identify a standardized, reproducible rehabilitation protocol with robotic hand assistance to implement highly customizable rehabilitation protocols; to achieve improved motor recovery in terms of both range of motion and muscle recruitment following upper limb rehabilitation through the Gloreha Sinfonia® (R-Touch Pro) robotic system; to achieve better motor performance following upper limb rehabilitation through the Gloreha Sinfonia® robotic system; to obtain improved eye-hand coordination, manual dexterity, and fine motor skills; to attain greater autonomy in ADL and, consequently, greater participation; to identify any clinical and functional characteristics that impact the rehabilitation outcome with Gloreha Sinfonia R-Touch Pro.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Kladruby, Czechia, 257 62
        • Not yet recruiting
        • Rehabilitation Center of Kladruby
        • Contact:
        • Principal Investigator:
          • Mgr. Lukas Chobot, PT
      • Lázně Bělohrad, Czechia, 50781
        • Not yet recruiting
        • Lázně Bělohrad a.s., Centrum komplexní rehabilitace
        • Contact:
        • Principal Investigator:
          • Kateřina Macháčková, MgR, PhD
      • Olomouc, Czechia, 77900
        • Not yet recruiting
        • Agel Hospital Prostějov, Rehabilitation Centre, Mathonova 1, Clinical Rehabilitation Centre FZV UP, Hněvotínská 3
        • Contact:
        • Principal Investigator:
          • Petr Konečný, MD, PhD
      • Prague, Czechia
        • Not yet recruiting
        • Charles University and General University Hospital in Prague
        • Contact:
        • Principal Investigator:
          • Kristýna Hoidekrová, OT, PhD
  • Italy
      • Bergamo, Italy, 24127
        • Not yet recruiting
        • Asst Papa Giovanni XXIII
        • Contact:
        • Principal Investigator:
          • Serena Monteleone, MD, PhD
      • Catanzaro, Italy
        • Not yet recruiting
        • University of Catanzaro "Magna Graecia"
        • Contact:
        • Principal Investigator:
          • Antonio Ammendolia, MD
      • Florence, Italy
        • Active, not recruiting
        • IRCCS Fondazione Don Gnocchi
      • Foggia, Italy, 7100
        • Not yet recruiting
        • Riuniti Hospital, Neurorehabilitation, Spinal Cord Rehab. and Functional Recovery Section
        • Contact:
        • Contact:
          • Salvatore Facciorusso, MD, PhD
        • Principal Investigator:
          • Andrea Santamato, MD, PhD
      • Messina, Italy, 98123
        • Not yet recruiting
        • IRCCS Centro Neurolesi Bonino-Pulejo, Innovation Technology Laboratory
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rocco Salvatore Calabrò, MD, PhD
    • CZ
      • San Vito sullo Ionio, CZ, Italy, 88067
        • Not yet recruiting
        • San Vito Hospital, Rehabilitation Unit
        • Principal Investigator:
          • Andrea Parente, MD
        • Contact:
    • Choose One...
      • Rome, Choose One..., Italy
        • Not yet recruiting
        • European Society of Physical and Rehabilitation Medicine, SISC in New Technologies and Robotics in Rehabilitation
        • Contact:
        • Principal Investigator:
          • Alessandro Giustini, MD
    • LC
      • Costa Masnaga, LC, Italy
        • Not yet recruiting
        • Valduce Hospital, Villa Beretta Rehabilitation Center
        • Principal Investigator:
          • Franco Molteni, MD
        • Contact:
    • PC
      • Fiorenzuola d'Arda, PC, Italy, 29017
        • Not yet recruiting
        • Department of Rehabilitative Medicine, AUSL Piacenza
        • Contact:
        • Principal Investigator:
          • Gianfranco Lamberti, MD, PhD
    • PG
      • Ummbertide, PG, Italy, 06019
        • Enrolling by invitation
        • Istituto Clinico Tiberino
    • Perugia
      • Passignano sul Trasimeno, Perugia, Italy, 06065
        • Not yet recruiting
        • Passignano Hospital, Department of Specialized Medicine, Usl Umbria 1
        • Contact:
        • Principal Investigator:
          • Maurizio Massucci, MD, PhD
    • RM
      • Rome, RM, Italy, 00128
        • Not yet recruiting
        • Fondazione Policlinico Universitario Campus Bio-Medico di Roma, UOC di Medicina Fisica e Riabilitativa-CESA
        • Contact:
        • Principal Investigator:
          • Federica Bressi, MD, PhD
      • Rome, RM, Italy, 00163
  • Russia
      • Moscow, Russia, 141052
        • Not yet recruiting
        • Medical Centre for Rehabilitation Treatment "Consilium"
        • Contact:
        • Principal Investigator:
          • Vyacheslav Anatolievich Filimonov, MD, PhD
  • Spain
      • Madrid, Spain, 28050
        • Not yet recruiting
        • Centro Lescer, Occupational Therapy and Physical Therapy Department
        • Contact:
        • Principal Investigator:
          • Estefania Morcillo de Mercado, OT
        • Principal Investigator:
          • Daniel Arturo Catillo, PT
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Not yet recruiting
        • Chiang Mai University, Department of Occupational Therapy, Faculty of Associated Medical Sciences
        • Contact:
        • Contact:
          • Dhippa, OT, PhD
        • Principal Investigator:
          • Sopida Apichai, OT, PhD
  • United States
    • Pennsylvania
      • Elkins Park, Pennsylvania, United States, 19027
        • Not yet recruiting
        • Jefferson Moss-Magee Rehabilitation, Department of PMR
        • Contact:
        • Contact:
          • Alexey Nastaskin, OT
        • Principal Investigator:
          • Alberto Esquenazi, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Both sexes
  • Age 18-90 years
  • Paresis of the upper limb following a recent cerebrovascular event (subacute ischemic or hemorrhagic stroke)
  • Moderate to mild muscle weakness in the thumb opponens, common finger flexors, and wrist flexors, assessed with complete joint movement in absence of gravity, Medical Research Council Scale (MRC) ≥ 2
  • Time from acute event <90 days
  • Ability to understand and sign the study informed consent
  • Ability to perform study procedures.

Exclusion Criteria:

  • Presence of other overlapping neurological disorders
  • Presence of osteoarticular or neuromuscular disorders affecting upper limb mobility
  • Severe psychiatric disorders
  • Severe cognitive (MMSE ≤ 17) and/or language impairment compromising exercise comprehension
  • Botulinum toxin injection in the affected upper limb within the last 60 days or planned during the study and follow-up period
  • Open wounds, infections, or unprotected skin lesions on the upper limb
  • Severe spasticity of the upper limb (biceps and wrist and finger flexors) (MAS > 3)
  • Inability to adhere to the exercise program due to low compliance
  • Participants who have not signed the informed consent for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group (EG)
Participants assigned to Experimental Group (EG) will follow 18+/-3sessions (from a minimum of 3 times to a maximum of 5 times/week) of robotic-assisted treatment for upper limb rehabilitation using the Gloreha Sinfonia (R-Touch Pro; BTL Robotics, USA) robotic device in addition to the standard rehabilitation program.
Device: Robotic Assisted Upper Limb Rehabilitation

The EG will follow a mixed rehabilitation approach for the upper limb, combining Robotic Assisted Upper Limb Rehabilitation and conventional physical therapy (PT) and/or occupational therapy (OT) with a total daily duration of 90 minutes. The Robotic Assisted UL Rehabilitation's session will last 30 minutes, with the following procedure provided:

  • First week: alternate between passive mobilization exercises, bilateral mode, and therapist-driven mode.
  • Second week: alternate between therapist-driven mode and active-assisted mobilization.
  • Third week: alternate between active-assisted mobilization and active mobilization.
  • Fourth week: alternate between active-assisted mobilization and active mobilization.
  • Fifth week: exclusively perform active mobilization. However, if this proposed progression does not match the patient's motor capabilities, the therapist will optimize the therapeutic program by selecting personalized exercises, following a progressive difficulty approach.
Other Names:
  • Gloreha Simfonia (R-TOUCH)
  • Robotic treatment for upper limb rehabilitation using the Gloreha Sinfonia (R-Touch)
Active Comparator: Control Group (CG)
Participants assigned to Control Group (CG) will follow 18+/-3 sessions (from a minimum of 3 times to a maximum of 5 times/week) of conventional tratment for upper limb rehabilitation in addition to the standard rehabilitation program.
Other: Control Group (CG)
The CG will follow a conventional occupational therapy (OT) and physical therapy (PT) program for upper limb rehabilitation, with a total daily duration of 90 minutes. Upper limb rehabilitation exercises will be performed with a therapist who will tailor the treatment according to the patient's clinical characteristics and needs. Specifically, upper limb treatment will consist of motor exercises (shoulder, elbow, wrist, and hand) through a mix of individual sessions with both passive and active interventions where possible.
Other Names:
  • Conventional treatment for upper limb rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugle Meyer Assessment for Upper Limb - Motor Part (score range: 0-66)
Time Frame: Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)

The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index designed to evaluate motor function, balance, sensation, and joint integrity in individuals with post-stroke hemiplegia. It is widely used in both clinical and research settings to assess disease severity, track motor recovery, and guide treatment planning.

In this study, the Motor Part of the FMA for the Upper Limb is the primary outcome measure, with scores ranging from a minimum of 0 to a maximum of 66. A higher score indicates better motor function on the impaired side.
Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Institute of Health Stroke Scale (NHISS)
Time Frame: Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)
The National Institutes of Health Stroke Scale (NIHSS) is a systematic, quantitative assessment tool to measure stroke-related neurological deficit. Its score ranges from 0 to 42, where higher scores indicate greater neurological impairment. In clinical practice it can be used to evaluate and document neurological status in acute stroke patients, determine appropriate treatment and assist in standardizing communication between healthcare practitioners. The NIHSS has been shown to be a predictor of both short and long term outcomes of stroke patients.
Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)
Pain scale (NRS 0-10) - at passive mobilization
Time Frame: Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)
Scores range from 0 to 10, where 0 indicates no pain and 10 represents the worst pain intensity the individual has ever experienced.
Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)
Modified Ashworth Scale (MAS)
Time Frame: Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)
The Modified Ashworth Scale (MAS) is used to assess spasticity. The Modified Ashworth Scale (MAS) has been utilised in the following populations: stroke, spinal cord injury, multiple sclerosis, cerebral palsy, traumatic brain injury, paediatric hypertonia and central nervous system lesions. The test is performed by extending the patients limb's first from a position of maximal possible flexion to maximal possible extension (the point at which the first soft resistance is met). Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion. Scores range from 0 to 4, where 0 indicates no increase in muscle tone and 4 represents a limb that is rigid in flexion or extension.
Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)
Medical Research Council Scale (MRC)
Time Frame: Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)
The Medical Research Council (MRC) Scale for Muscle Strength is a commonly used scale for assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction). The Criteria requires that each of the six muscle groups listed in the table are examined bilaterally, each with a score from 0 to 5 according to the scale in the right hand column.
Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)
Box and Block test (BBT)
Time Frame: Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It can be used with a wide range of populations, including clients with stroke.The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds.
Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)
Nine Hole Peg Test (NHPT)
Time Frame: Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)
The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses. The Nine-Hole Peg Test is administered by asking the client to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container.Scores are based on the time taken to complete the activity, recorded in seconds.
Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)
Modified Barthel Index (mBI)
Time Frame: Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)
The modified Barthel Index (mBI) is a well-established patient-centered outcome measure commonly administrated in rehabilitation settings to evaluate the functional status of patients at admission and discharge.
Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)
Stroke Impact Scale (SIS)
Time Frame: Day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)
The Stroke Impact Scale (SIS) is a patient-reported outcome measure that evaluates the biopsychosocial aspects of life after stroke. Developed by Duncan et al. at the University of Kansas Medical Center (KUMC) in 1999, it was first published as version 2.0. The original 64-item tool was later refined through Rasch analysis to 59 items, resulting in the current version 3.0. The SIS includes multiple domains, each scored from 0 to 100, with higher scores indicating better function and quality of life. For patients unable to self-report, a proxy version called the Stroke Impact Scale-16 is available.
Day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)
Robotic Therapy Acceptance Assessment
Time Frame: Day 35 (T2 - After treatment)
The Robotic Therapy Acceptance Assessment is a questionnaire designed to evaluate patients' perceptions of robotic therapy. It includes items related to various aspects of the experience, namely 'Comfort,' 'Absence of pain,' 'Fatigue,' 'Enjoyment,' 'Advantages,' 'Desire to continue,' and 'Willingness to recommend it to others.' Each item is scored using a Likert scale ranging from 0 to 7, where 0 indicates strong disagreement and 7 represents complete agreement.
Day 35 (T2 - After treatment)
ABILHAND questionnaire
Time Frame: Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)

The ABILHAND questionnaire is an interview-based, patient-reported measure assessing perceived difficulty in performing manual activities in daily life. It evaluates the active function of the upper limbs and the ability to perform bimanual tasks, regardless of how they are executed. This assessment represents the activity domain of the International Classification of Functioning, Disability, and Health (ICF).

Validated versions are available for chronic stroke, rheumatoid arthritis, systemic sclerosis, and hand surgery. The scores range from a minimum of 0 to a maximum of 46, with higher scores indicating better performance. All versions, along with assessment details, downloadable materials, and a link to the Rasch analysis, can be accessed through the official website.
Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)
Canadian Occupational Performance Measure scale
Time Frame: Day 0 (T1- basline), and day 35 (T2 - After treatment)

The Canadian Occupational Performance Measure (COPM) is an evidence-based outcome measure designed to assess a client's self-perception of performance in daily activities over time. As a semi-structured interview, it facilitates open dialogue between the client and therapist, focusing on issues most relevant to the client.

The COPM evaluates two domains: Performance and Satisfaction, both scored on a scale from a minimum of 0 to a maximum of 10. Each domain score represents the mean of 10 items, with each item rated on a Likert scale from 0 to 10. A higher score (10) indicates the best outcome.
Day 0 (T1- basline), and day 35 (T2 - After treatment)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
IMU-based targeted Box and Block Test (t-BBT)
Time Frame: Day 0 (T1- basline), and day 35 (T2 - After treatment)
Instrumental assessment of manual dexterity will be conducted using a sensorized and modified version of the Box and Block Test (BBT). This modified version involves moving 10 cubes from one side of the box to the other positioned on a 5x2 grid. In a subset of EG subjects, kinematic parameters will be measured using Inertial Measurement Units (IMUs), and electrophysiological parameters will be recorded via surface electromyography (sEMG). The assessment will quantify joint kinematics, including range of motion and movement smoothness, as well as upper limb muscle activation patterns, such as muscle onset timing and co-contraction levels. This approach enables a comprehensive evaluation of motor performance during the BBT.
Day 0 (T1- basline), and day 35 (T2 - After treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele Roma

Investigators

  • Principal Investigator: Sanaz Pournajaf, DPT, PhD, IRCCS San Raffaele Roma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2025

Primary Completion (Actual)

February 28, 2026

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

February 21, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 266/IRE/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) will be shared with qualified researchers upon reasonable request, following ethical and regulatory approvals.

IPD Sharing Time Frame

Individual participant data (IPD) will be available upon publication of the main results and will remain accessible for at least five years.

IPD Sharing Access Criteria

Qualified researchers may request access to the data by submitting a proposal outlining their research objectives. Access will be granted upon ethical and regulatory approval and under a data-sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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