Robotic upper-limb rehabilitation after recent (subacute) stroke
Efficacy of Robotic Rehabilitation for Neuro Recovery of the Upper Limb in Subacute Stroke Survivors: An International Multicenter Randomized Controlled Trial
This trial will test whether adding the Gloreha Sinfonia robotic exoskeleton to usual therapy helps people with recent stroke regain arm and hand movement better than conventional therapy alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Roma Academic / other |
| Locations | 21 sites (Elkins Park, Pennsylvania and 20 other locations) |
| Trial ID | NCT06839482 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized controlled trial compares robotic-assisted upper limb therapy using the Gloreha Sinfonia exoskeleton plus conventional rehabilitation to conventional therapy alone in people with subacute post-stroke paresis. Adults within 90 days of ischemic or hemorrhagic stroke with mild-to-moderate upper limb weakness (MRC ≥2) are randomized to the experimental or control group and receive in-person treatment at participating centers. Primary outcome is change in the Fugl-Meyer Assessment motor score for the upper limb measured at baseline, immediately post-treatment, and at 3 months, with secondary measures including muscle strength, range of motion, eye–hand coordination, and manual dexterity. Remote administration of clinical scales is used for follow-up, and standard exclusion criteria include other neurological or musculoskeletal conditions, severe cognitive or language impairment, recent botulinum toxin injection, or open wounds on the limb.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–90 within 90 days of an ischemic or hemorrhagic stroke who have mild-to-moderate upper limb weakness (MRC ≥2) and can understand and consent to the protocol.
Not a fit: Patients with severe cognitive or language deficits, very weak or flaccid upper limbs (MRC <2), overlapping neurological or musculoskeletal conditions, recent botulinum toxin injections, or unhealed skin lesions are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the robotic approach could speed and enhance recovery of arm and hand function, improving independence with daily activities.
How similar studies have performed: Previous trials of robotic-assisted upper limb rehabilitation have shown promising but mixed results, with improvements in some motor outcomes but variability across devices and protocols.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
Elkins Park, Pennsylvania and 20 other locations
- Jefferson Moss-Magee Rehabilitation, Department of PMR — Elkins Park, Pennsylvania, United States (Not_yet_recruiting)
- Rehabilitation Center of Kladruby — Kladruby, Czechia (Not_yet_recruiting)
- Lázně Bělohrad a.s., Centrum komplexní rehabilitace — Lázně Bělohrad, Czechia (Not_yet_recruiting)
- Agel Hospital Prostějov, Rehabilitation Centre, Mathonova 1, Clinical Rehabilitation Centre FZV UP, Hněvotínská 3 — Olomouc, 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, 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, Italy (Not_yet_recruiting)
- Passignano Hospital, Department of Specialized Medicine, Usl Umbria 1 — Passignano sul Trasimeno, Perugia, Italy (Not_yet_recruiting)
- Istituto Clinico Tiberino — Ummbertide, Pg, Italy (Enrolling_by_invitation)
- Fondazione Policlinico Universitario Campus Bio-Medico di Roma, UOC di Medicina Fisica e Riabilitativa-CESA — Rome, Rm, Italy (Not_yet_recruiting)
- IRCCS San Raffaele Roma — Rome, Rm, Italy (Recruiting)
- ASST Papa Giovanni XXIII — Bergamo, 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, Italy (Not_yet_recruiting)
- IRCCS Centro Neurolesi Bonino-Pulejo, Innovation Technology Laboratory — Messina, Italy (Not_yet_recruiting)
- Medical Centre for Rehabilitation Treatment "Consilium" — Moscow, Russia (Not_yet_recruiting)
- Centro Lescer, Occupational Therapy and Physical Therapy Department — Madrid, Spain (Not_yet_recruiting)
- Chiang Mai University, Department of Occupational Therapy, Faculty of Associated Medical Sciences — Chiang Mai, Thailand (Not_yet_recruiting)
Study contacts
- Principal investigator: Sanaz Pournajaf, DPT, PhD — IRCCS San Raffaele Roma
- Study coordinator: Sanaz Pournajaf, DPT, PhD
- Email: sanaz.pournajfa@sanraffaele.it
- Phone: +39 0652252405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.