Robotic Rehabilitation of the Upper Limb in Subacute Stroke (NCT06839482)
Efficacy of Robotic Rehabilitation for Neuro Recovery of the Upper Limb in Subacute Stroke Survivors: An International Multicenter Randomized Controlled Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Jefferson Moss-Magee Rehabilitation, Department of PMR — Elkins Park, Pennsylvania
Age range: 18 Years to 85 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (21 Sites)
- Jefferson Moss-Magee Rehabilitation, Department of PMR — Elkins Park, Pennsylvania
- 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,
- European Society of Physical and Rehabilitation Medicine, SISC in New Technologies and Robotics in Rehabilitation — Rome, Choose One...
- San Vito Hospital, Rehabilitation Unit — San Vito sullo Ionio, CZ
- Valduce Hospital, Villa Beretta Rehabilitation Center — Costa Masnaga, LC
- Department of Rehabilitative Medicine, AUSL Piacenza — Fiorenzuola d'Arda, PC
- Passignano Hospital, Department of Specialized Medicine, Usl Umbria 1 — Passignano sul Trasimeno, Perugia
- Istituto Clinico Tiberino — Ummbertide, PG
- Fondazione Policlinico Universitario Campus Bio-Medico di Roma, UOC di Medicina Fisica e Riabilitativa-CESA — Rome, RM
- IRCCS San Raffaele Roma — Rome, RM
- 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,
📞 Contact the Study Coordinator
Phone: +39 0652252405
Email: sanaz.pournajfa@sanraffaele.it
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.