Robotic upper-limb rehabilitation after recent (subacute) stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• IRCCS San Raffaele Roma
  Rome, Rm, Italy Recruiting
• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.