Robotic Rehabilitation of the Upper Limb in Subacute Stroke
NCT ID: NCT06839482
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
130 participants
INTERVENTIONAL
2025-02-06
2028-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
85 Years
ALL
No
Sponsors
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IRCCS San Raffaele Roma
OTHER
Responsible Party
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Principal Investigators
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Sanaz Pournajaf, DPT, PhD
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele Roma
Locations
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Jefferson Moss-Magee Rehabilitation, Department of PMR
Elkins Park, Pennsylvania, United States
Rehabilitation Center of Kladruby
Kladruby, , Czechia
Lázně Bělohrad a.s., Centrum komplexní rehabilitace
Lázně Bělohrad, , Czechia
Agel Hospital Prostějov, Rehabilitation Centre, Mathonova 1, Clinical Rehabilitation Centre FZV UP, Hněvotínská 3
Olomouc, , Czechia
Charles University and General University Hospital in Prague
Prague, , Czechia
European Society of Physical and Rehabilitation Medicine, SISC in New Technologies and Robotics in Rehabilitation
Rome, Choose One..., Italy
San Vito Hospital, Rehabilitation Unit
San Vito sullo Ionio, CZ, Italy
Valduce Hospital, Villa Beretta Rehabilitation Center
Costa Masnaga, LC, Italy
Department of Rehabilitative Medicine, AUSL Piacenza
Fiorenzuola d'Arda, PC, Italy
Passignano Hospital, Department of Specialized Medicine, Usl Umbria 1
Passignano sul Trasimeno, Perugia, Italy
Fondazione Policlinico Universitario Campus Bio-Medico di Roma, UOC di Medicina Fisica e Riabilitativa-CESA
Rome, RM, Italy
IRCCS San Raffaele Roma
Rome, RM, Italy
ASST Papa Giovanni XXIII
Bergamo, , Italy
University of Catanzaro "Magna Graecia"
Catanzaro, , Italy
IRCCS Fondazione Don Gnocchi
Florence, , Italy
Riuniti Hospital, Neurorehabilitation, Spinal Cord Rehab. and Functional Recovery Section
Foggia, , Italy
IRCCS Centro Neurolesi Bonino-Pulejo, Innovation Technology Laboratory
Messina, , Italy
Medical Centre for Rehabilitation Treatment "Consilium"
Moscow, , Russia
Centro Lescer, Occupational Therapy and Physical Therapy Department
Madrid, , Spain
Chiang Mai University, Department of Occupational Therapy, Faculty of Associated Medical Sciences
Chiang Mai, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Alexey Nastaskin, OT
Role: backup
Salvatore Facciorusso, MD, PhD
Role: backup
Dhippa, OT, PhD
Role: backup
Related Links
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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
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.
Other Identifiers
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266/IRE/24
Identifier Type: -
Identifier Source: org_study_id
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