Robotic Rehabilitation of the Upper Limb in Subacute Stroke

NCT06839482 | Recruiting DMC FDA Device

• 1 other identifier: 266/IRE/24
• Study Type: interventional
• Target: 130
• Locations: 6 countries
• Sites: 21

Brief Summary

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.

Conditions

Stroke

Keywords

Stroke; Upper Limb; Hand; Rehabilitation; Robotic- Assisted Therapy; Subacute phase; Activities of Daily Living (ADL); Quality of Life

Outcome Measures

Primary Outcomes (1)

• Fugle Meyer Assessment for Upper Limb - Motor Part (score range: 0-66)

  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 Outcomes (11)

• National Institute of Health Stroke Scale (NHISS)

  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

  Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)

• Modified Ashworth Scale (MAS)

  Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)

• Medical Research Council Scale (MRC)

  Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)

• Box and Block test (BBT)

  Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)

Other Outcomes (1)

• IMU-based targeted Box and Block Test (t-BBT)

  Day 0 (T1- basline), and day 35 (T2 - After treatment)

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

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

Control Group (CG)

ACTIVE COMPARATOR

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)

Interventions

Control Group (CG) OTHER

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.

Also known as: Conventional treatment for upper limb rehabilitation

Control Group (CG)

Robotic Assisted Upper Limb Rehabilitation DEVICE

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.

Also known as: Gloreha Simfonia (R-TOUCH), Robotic treatment for upper limb rehabilitation using the Gloreha Sinfonia (R-Touch)

Experimental Group (EG)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (21)

Jefferson Moss-Magee Rehabilitation, Department of PMR

Elkins Park, Pennsylvania, 19027, United States

NOT YET RECRUITING

Rehabilitation Center of Kladruby

Kladruby, 257 62, Czechia

NOT YET RECRUITING

Lázně Bělohrad a.s., Centrum komplexní rehabilitace

Lázně Bělohrad, 50781, Czechia

NOT YET RECRUITING

Agel Hospital Prostějov, Rehabilitation Centre, Mathonova 1, Clinical Rehabilitation Centre FZV UP, Hněvotínská 3

Olomouc, 77900, Czechia

NOT YET RECRUITING

Charles University and General University Hospital in Prague

Prague, Czechia

NOT YET RECRUITING

European Society of Physical and Rehabilitation Medicine, SISC in New Technologies and Robotics in Rehabilitation

Rome, Choose One..., Italy

NOT YET RECRUITING

San Vito Hospital, Rehabilitation Unit

San Vito sullo Ionio, CZ, 88067, Italy

NOT YET RECRUITING

Valduce Hospital, Villa Beretta Rehabilitation Center

Costa Masnaga, LC, Italy

NOT YET RECRUITING

Department of Rehabilitative Medicine, AUSL Piacenza

Fiorenzuola d'Arda, PC, 29017, Italy

NOT YET RECRUITING

Passignano Hospital, Department of Specialized Medicine, Usl Umbria 1

Passignano sul Trasimeno, Perugia, 06065, Italy

NOT YET RECRUITING

Istituto Clinico Tiberino

Ummbertide, PG, 06019, Italy

ENROLLING BY INVITATION

Fondazione Policlinico Universitario Campus Bio-Medico di Roma, UOC di Medicina Fisica e Riabilitativa-CESA

Rome, RM, 00128, Italy

NOT YET RECRUITING

IRCCS San Raffaele Roma

Rome, RM, 00163, Italy

RECRUITING

ASST Papa Giovanni XXIII

Bergamo, 24127, Italy

NOT YET RECRUITING

University of Catanzaro "Magna Graecia"

Catanzaro, Italy

NOT YET RECRUITING

IRCCS Fondazione Don Gnocchi

Florence, Italy

ACTIVE NOT RECRUITING

Riuniti Hospital, Neurorehabilitation, Spinal Cord Rehab. and Functional Recovery Section

Foggia, 7100, Italy

NOT YET RECRUITING

IRCCS Centro Neurolesi Bonino-Pulejo, Innovation Technology Laboratory

Messina, 98123, Italy

NOT YET RECRUITING

Medical Centre for Rehabilitation Treatment "Consilium"

Moscow, 141052, Russia

NOT YET RECRUITING

Centro Lescer, Occupational Therapy and Physical Therapy Department

Madrid, 28050, Spain

NOT YET RECRUITING

Chiang Mai University, Department of Occupational Therapy, Faculty of Associated Medical Sciences

Chiang Mai, 50200, Thailand

NOT YET RECRUITING

Related Links

• 2015 American Heart Association/American Stroke Association Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment: A Guideline for Healthcare Professionals From the American
• S.P. and E.A. Diffusion, "Ictus cerebrale: SPREAD linee guida italiane," 2016.
• C.J. Winstein et al., "Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals from the American Heart Association/American Stroke Association," Stroke, 47(6), 2016.
• Evidence-based review of stroke rehabilitation, 20th Edition (EBRS)
• Task-Based Mirror Therapy Augmenting Motor Recovery in Poststroke Hemiparesis: A Randomized Controlled Trial
• Mirror Therapy for Stroke Rehabilitation
• Clinical relevance of action observation in upper-limb stroke rehabilitation: a possible role in recovery of functional dexterity.
• Motor impairment as a predictor of functional recovery and guide to rehabilitation treatment after stroke
• Action Observation Therapy
• Use of the Medical Research Council Muscle Strength GradingSystem in the Upper Extremity
• Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke.
• Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke.
• Upper limb robot-assisted rehabilitation versus physical therapy on subacute stroke patients: A follow-up study.
• Reliability of the Fugl-Meyer assessment for testing motor performance in patients following stroke.
• Reliability and validity of the Medical Research Council (MRC) scale and a modified scale for testing muscle strength in patients with radial palsy.
• Stroke Scale
• The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance.
• Modified Ashworth Scale. \[Updated 2023 May 1\]. In: StatPearls \[Internet\]. Treasure Island (FL): StatPearls Publishing
• Adult norms for the Box and Block Test of manual dexterity
• Hand strength and dexterity
• abilhand
• Rasch analysis of a new stroke-specific outcome scale: The Stroke Impact Scale.
• Acceptability of robotic technology in neuro-rehabilitation: preliminary results on chronic stroke patients.

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sanaz Pournajaf, DPT, PhD

  IRCCS San Raffaele Roma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanaz Pournajaf, DPT, PhD

CONTACT

+39 0652252405; sanaz.pournajfa@sanraffaele.it

Carrie Louise Thouant, OT, MSc

CONTACT

+39 0652252338; carrielouise.thouant@sanraffaele.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this study all the outcome assessors will be blind to the gruop assignment of the study participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 21, 2025
• Study Start: February 6, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): January 31, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Individual participant data (IPD) will be available upon publication of the main results and will remain accessible for at least five years.
• 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.

Locations

RU (1); IT (13); TH (1); ES (1); US (1); CZ (4)