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NCT06839482 · ClinicalTrials.gov registry record · NA
Robotic Rehabilitation of the Upper Limb in Subacute Stroke
A NA study of Stroke, sponsored by IRCCS San Raffaele Roma.
- Recruiting
- Registry status
- NA
- Development phase
- 130
- Enrollment target
- 20
- Study locations
NCT06839482: Recruiting NA study of Stroke, sponsored by IRCCS San Raffaele Roma.
NCT06839482 is a NA study of Stroke that is actively recruiting participants, run by IRCCS San Raffaele Roma. The registered enrollment target is 130 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06839482, a NA study of Stroke, is actively recruiting participants, sponsored by IRCCS San Raffaele Roma.
- RECRUITING
- Registry status
- NA
- Development phase
- 130 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DEVICE Robotic Assisted Upper Limb Rehabilitation
- OTHER Control Group (CG)
Study Locations (20)
Other
- Rehabilitation Center of Kladruby - Kladruby
- Lázně Bělohrad a.s., Centrum komplexní rehabilitace - Lázně Bělohrad
- Agel Hospital Prostějov, Rehabilitation Centre, Mathonova 1, Clinical Rehabilitation Centre FZV UP, Hněvotínská 3 - Olomouc
- Charles University and General University Hospital in Prague - Prague
- ASST Papa Giovanni XXIII - Bergamo
- University of Catanzaro "Magna Graecia" - Catanzaro
- IRCCS Fondazione Don Gnocchi - Florence
- Riuniti Hospital, Neurorehabilitation, Spinal Cord Rehab. and Functional Recovery Section - Foggia
- IRCCS Centro Neurolesi Bonino-Pulejo, Innovation Technology Laboratory - Messina
- Medical Centre for Rehabilitation Treatment "Consilium" - Moscow
- Centro Lescer, Occupational Therapy and Physical Therapy Department - Madrid
- Chiang Mai University, Department of Occupational Therapy, Faculty of Associated Medical Sciences - Chiang Mai
RM
- Fondazione Policlinico Universitario Campus Bio-Medico di Roma, UOC di Medicina Fisica e Riabilitativa-CESA - Rome
- IRCCS San Raffaele Roma - Rome
Pennsylvania
- Jefferson Moss-Magee Rehabilitation, Department of PMR - Elkins Park
Choose One...
- European Society of Physical and Rehabilitation Medicine, SISC in New Technologies and Robotics in Rehabilitation - Rome
CZ
- San Vito Hospital, Rehabilitation Unit - San Vito sullo Ionio
LC
- Valduce Hospital, Villa Beretta Rehabilitation Center - Costa Masnaga
PC
- Department of Rehabilitative Medicine, AUSL Piacenza - Fiorenzuola d'Arda
Perugia
- Passignano Hospital, Department of Specialized Medicine, Usl Umbria 1 - Passignano sul Trasimeno
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2025-02-06 |
| Est. Completion | 2028-01-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06839482
The ClinicalTrials.gov registry entry for NCT06839482 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (99% lower). The listed sponsor is IRCCS San Raffaele Roma, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Robotic Assisted Upper Limb Rehabilitation is the first listed.
NCT06839482 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, RM, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06839482 about?
NCT06839482 is a clinical study titled "Robotic Rehabilitation of the Upper Limb in Subacute Stroke". 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 mo...
What is the current status of trial NCT06839482?
This trial is currently recruiting. It is a NA study. The enrollment target is 130 participants. The study started on 2025-02-06. Estimated completion is 2028-01-31.
What conditions does trial NCT06839482 study?
This clinical trial studies the following conditions: Stroke.
What interventions are being tested in trial NCT06839482?
The interventions under investigation include: Robotic Assisted Upper Limb Rehabilitation (DEVICE), Control Group (CG) (OTHER).
Who is sponsoring clinical trial NCT06839482?
This trial is sponsored by IRCCS San Raffaele Roma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06839482 being conducted?
This trial has 20 study locations across Pennsylvania, Choose One..., CZ, LC, PC. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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