NCT06763874Completed
Usability and Acceptability Study of a Functional Electro-stimulator Controlled by Electromyographic Signal (FitFES)
Pilot Study of Usability and Acceptability for the Optimization of a Functional Electrical Stimulator Controlled by Electromyographic Signal for the Rehabilitation of the Upper Limb in Persons Post-stroke
Source: ClinicalTrials.gov · Last updated 28 Feb 2025
Brief summary (registry, in English)
Functional recovery of the upper limb after a cerebral stroke is one of the major critical issues in rehabilitation. The advent of innovative technologies can be helpful to rehabilitators and intervene where there is no other solution but a clear therapeutic indication. The use of functional electrostimulators can actively and functionally support movements, helping people affected by stroke to complete a motor gesture taking into account their residual capacities.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 19 Dec 2024
- Start date
- 14 Jan 2025
- Primary completion date
- 25 Feb 2025
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Diseases
- Stroke
- NCT number
- NCT06763874
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 14 Jan 2025 to the primary completion date, 25 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Stroke Inclusion Criteria:
- Age equal to or greater than 18 years
- Diagnosis of first ischemic or hemorrhagic unilateral stroke for at least two weeks
- Stroke Exclusion Criteria
- Mini Mental State Examination (corrected for age and schooling) \< 24
- Clinical evidence of visuospatial disorders, ideomotor apraxia, behavioral disorders, neglect, severe visual and auditory sensory disorders that prevent the use of the device
- Major head trauma
- Cardio-respiratory or internal clinical instability
- Pregnancy
- Severe spasticity (Ashworth scale \> 3)
- Skin integrity issues on the surface interfaced with the device
- Implanted electronic devices
- Epilepsy
- Severe peripheral neuropathies
- Healthy health care professionals inclusion criteria:
- Age equal to or greater than 18 years
- Healthy health care professionals exclusion criteria:
- Pregnancy
- Skin integrity issues on the surface interfaced with the device
- Implanted electronic devices
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Fondazione Don Carlo Gnocchi ONLUS Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.