Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Rehabilitation for upper limb impairment after stroke using action observation and muscle stimulation

Official title: Efficacy of a Rehabilitation Treatment Using Observation THerapy Enhanced by MuscLe Synergy-derived ELectrical StimulatiOn in Post-stroke Patients (OTHELLO)

Run by Fondazione Don Carlo Gnocchi ETS · NCT06055569 · Data updated 2026-11-12

This study is testing if a new rehabilitation method that combines watching movements with electrical stimulation can help adults recover better from upper arm weakness after a stroke compared to just watching movements alone.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorFondazione Don Carlo Gnocchi ETS
Academic / other
Locations1 site (Milan, Italia)
StatusRecruiting
StartedNovember 1, 2023
Main results expectedDecember 1, 2025
Study endsMarch 31, 2026
Registry record updatedNovember 13, 2024
Trial IDNCT06055569 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 years old who have upper arm motor impairment due to a unilateral stroke occurring within the last six months.

Probably not a fit

Patients with neurological or orthopedic conditions that interfere with upper limb exercises or those with severe cognitive impairments may not benefit from this study.

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

What this trial studies

This clinical trial investigates the effectiveness of a combined rehabilitation approach using Action Observation Therapy (AOT) and Neuromuscular Electrical Stimulation (NMES) for patients with upper limb motor impairment following a stroke. The study aims to determine if this dual intervention is more effective than AOT alone or the observation of non-motor stimuli. Participants will be individuals aged 18 and older who have experienced a unilateral stroke within the last six months and have measurable upper arm motor impairment. The trial will assess improvements in motor function through various rehabilitation protocols.

Why it matters

Potential benefit: If successful, this approach could significantly enhance recovery and improve motor function in stroke patients with upper limb impairments.

How similar studies have gone: While the combination of AOT and NMES has not been previously tested, similar rehabilitation approaches have shown promise in improving motor function in stroke patients.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age over 18 years;
* Upper arm motor impairment after unilateral stroke as verified by MRI or CT;
* Two weeks up to 6 months after stroke;
* Grading of upper arm motor impairment\>2 at Medical Research Council scale (MRC).

Exclusion Criteria:

* Neurological/orthopedic issues that would interfere with upper limb exercises;
* Presence of any medical condition that represents a contraindication to Magnetic Resonance Imaging (MRI) examination or to Transcranial Magnetic Stimulation (TMS);
* Presence of dermatologic issues that will interfere with neuromuscular stimulator;
* Presence of electronic subcutaneous implants;
* Presence of peripheral neuropathy;
* Epilepsy;
* Pregnancy;
* Presence of severe cognitive impairment, including language comprehension detected during the neurological evaluation.

Where it's running

  • IRCCS Fondazione Don Carlo Gnocchi
    Milan, Italia, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.