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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Fondazione Don Carlo Gnocchi ETS Academic / other |
| Locations | 1 site (Milan, Italia) |
| Status | Recruiting |
| Started | November 1, 2023 |
| Main results expected | December 1, 2025 |
| Study ends | March 31, 2026 |
| Registry record updated | November 13, 2024 |
| Trial ID | NCT06055569 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
- Study coordinator: Monia Cabinio, Ph.D.
- Email: mcabinio@dongnocchi.it
- Phone: +390240308952
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Accelerated repetitive transcranial magnetic stimulation (rTMS) versus sham for post-stroke apathy
This project will try a faster course of rTMS to see if it reduces persistent apathy in people at least six months after an ischemic or hemorrhagic stroke.
-
Deep phenotyping to explore recovery in young adults after stroke
This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.
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Wrist-worn device to encourage use of the weaker arm after a recent stroke
This trial tests whether a wrist-worn sensor system plus motor and behavioral home coaching helps people 1–6 months after a stroke with moderate arm weakness use their affected arm more than a usual home-exercise program.
-
Stem cell therapy for chronic stroke recovery
This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.
-
Trans-spinal magnetic stimulation for improving mobility in chronic stroke patients
This study is testing if a new type of magnetic treatment can help improve walking and movement in adults who have had a stroke for a long time.
-
Wrist sensor system to increase use of the weak arm at home after stroke
This program will test whether wearing the StrokeWear wrist sensor combined with a motor and behavioral home program helps chronic stroke survivors with hemiparesis use their affected arm more than a standard home-exercise plan.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.