Rehabilitation for upper limb impairment after stroke using action observation and muscle stimulation
Efficacy of a Rehabilitation Treatment Using Observation THerapy Enhanced by MuscLe Synergy-derived ELectrical StimulatiOn in Post-stroke Patients (OTHELLO)
NA · Fondazione Don Carlo Gnocchi Onlus · NCT06055569
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus (other) |
| Locations | 1 site (Milan, Italia) |
| Trial ID | NCT06055569 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan, Italia
- IRCCS Fondazione Don Carlo Gnocchi — Milan, Italia, Italy (RECRUITING)
Study contacts
- Study coordinator: Monia Cabinio, Ph.D.
- Email: mcabinio@dongnocchi.it
- Phone: +390240308952
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.
Conditions: Stroke, Stroke Sequelae