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Robotic Arm Exoskeleton Therapy for Upper Limb Recovery After Stroke

Tests a robotic exoskeleton added to usual therapy in adults with recent stroke.

Key facts

Who runs it
IRCCS San Raffaele Roma
Where
Bergamo, Catanzaro, Costa Masnaga, Fiorenzuola d'Arda, Florence, Foggia, Messina, Passignano sul Trasimeno, Rome, San Vito sullo Ionio, and Ummbertide, ItalySee the 13 sitesAlso in 5 other countries, 8 sites
Trial code
Registry title
Robotic Rehabilitation of the Upper Limb in Subacute Stroke
Status
Recruiting
People taking part
130 people, planned
Started
6 Feb 2025
Expected to end
31 Jan 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Robotic Assisted Upper Limb Rehabilitation
  • Control Group (CG)
Record updated
23 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who have weakness in one arm and hand after a recent stroke. It tests robot-assisted arm therapy added to usual therapy.

Age
18-90 years in the inclusion criteria (the record's age field says 18 to 85 years)
Sex
Women and men can both join.
Disease stage
Arm weakness after a recent stroke (ischemic or hemorrhagic), less than 90 days after the event. Muscle weakness is moderate to mild (MRC ≥ 2) in the thumb, finger and wrist muscles.
Earlier treatment
No botulinum toxin injection in the affected arm within the last 60 days, and none planned during the study.

Main reasons for not taking part

  • Other neurological disorders that overlap with the stroke
  • Bone, joint or muscle disorders that limit arm movement
  • Severe mental illness
  • Severe memory, thinking or language problems that make exercises hard to understand (MMSE ≤ 17)
  • Severe stiffness of the arm muscles (MAS > 3)

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Open wounds, infections, or unprotected skin lesions on the upper limb
  • Botulinum toxin injection in the affected upper limb within the last 60 days or planned during the study and follow-up period
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 85 years old?

Where in Italy

Also in 5 other countries, 8 sites

  • Asst Papa Giovanni XXIIIBergamo, ItalyContact: Serena Monteleone, MD, PhDNot yet recruiting
  • University of Catanzaro "Magna Graecia"Catanzaro, ItalyContact: Alessandro De Sire, MD, PhDNot yet recruiting
  • Valduce Hospital, Villa Beretta Rehabilitation CenterCosta Masnaga, ItalyContact: Eleonora Guanziroli, Ing. PhDNot yet recruiting
  • Department of Rehabilitative Medicine, AUSL PiacenzaFiorenzuola d'Arda, ItalyContact: Gianfranco Lamberti, MD, PhDNot yet recruiting
  • IRCCS-Fondazione Don GnocchiFlorence, ItalyContact: Sanaz Pournajaf, DPT, PhDNo longer taking part
  • Riuniti Hospital, Neurorehabilitation, Spinal Cord Rehab. and Functional Recovery SectionFoggia, ItalyContact: Stefania Spina, MD, PhDNot yet recruiting
  • IRCCS Centro Neurolesi Bonino-Pulejo, Innovation Technology LaboratoryMessina, ItalyContact: Rocco Salvatore Calabrò, MD, PhDNot yet recruiting
  • Passignano Hospital, Department of Specialized Medicine, Usl Umbria 1Passignano sul Trasimeno, ItalyContact: Maurizio Massucci, MD, PhDNot yet recruiting
  • European Society of Physical and Rehabilitation Medicine, SISC in New Technologies and Robotics in RehabilitationRome, ItalyContact: Alessandro Giustini, MDNot yet recruiting
  • Fondazione Policlinico Universitario Campus Bio-Medico di Roma, UOC di Medicina Fisica e Riabilitativa-CESARome, ItalyContact: Federica Bressi, MD, PhDNot yet recruiting
  • IRCCS San Raffaele RomaRome, ItalyContact: Sanaz Pournajaf, DPT, PhDTaking people
  • San Vito Hospital, Rehabilitation UnitSan Vito sullo Ionio, ItalyContact: Andrea Parente, MDNot yet recruiting
  • Istituto Clinico TiberinoUmmbertide, ItalyContact: Sanaz Pournajaf, DPT, PhDEnrolling by invitation

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Experimental Group (EG)Treatment being tested

    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.

    Treatment: Robotic Assisted Upper Limb Rehabilitation

  • Control Group (CG)Existing treatment, for comparison

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Efficacy of Robotic Rehabilitation for Neuro Recovery of the Upper Limb in Subacute Stroke Survivors: An International Multicenter Randomized Controlled Trial
Plain-language title
Robotic Arm Exoskeleton Therapy for Upper Limb Recovery After StrokeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06839482, who can take part
Record updated
23 April 2026