Effects of a device for stimulating muscles in post-stroke patients

Pilot Study on the Effects Induced by an Electromyographic-controlled Functional Electrical Stimulator (FitFES) for Upper Limb Rehabilitation in Post-stroke Patients

This study tests if a special wearable device can help people who have had a stroke improve their arm movement better than regular rehab alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione Don Carlo Gnocchi Onlus (other)
• Locations: 3 sites (Genova and 2 other locations)
• Trial ID: NCT06928857 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a wearable device called FitFES, which uses EMG-controlled functional electrical stimulation to aid in the rehabilitation of upper limb motor function in post-stroke patients. Participants will be divided into two groups: one receiving the FitFES device during rehabilitation sessions and the other undergoing traditional rehabilitation without the device. The study aims to compare the outcomes of both groups after a series of task-oriented exercises over 15 sessions. Data will be collected before and after the rehabilitation program to assess improvements in motor function.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have experienced a first unilateral stroke and have some residual muscle activity in their upper limbs.

Not a fit: Patients with severe cognitive impairments, significant behavioral disorders, or other severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance rehabilitation outcomes for post-stroke patients, improving their upper limb functionality.

How similar studies have performed: Previous studies have shown promise with similar EMG-controlled stimulation approaches, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

* 18 years or older
* Diagnosis of first ischemic or hemorrhagic unilateral stroke for at least two weeks
* Medical Research Council score for at least one upper limb muscle greater than 0 and less than 5 (excluding extremes).
* Signed informed consent

Exclusion Criteria:

* Score at the Mini Mental State Examination (adjusted for age and schooling) \< 24
* Clinical evidence in the case of visual disturbance, ideomotor apraxia, behavioral disorders, neglect, sensory, visual and auditory disturbances of severe degree or otherwise that prevent use of the device
* Major head trauma
* Cardio-respiratory or internal clinical instability
* State of pregnancy or lactation
* Severe spasticity (Ashworth \> 3)
* Skin integrity problems at the interface surface with the device
* Implanted electronic devices
* Epilepsy not medically controlled
* Severe peripheral neuropathy
* Recent interventions
* Thrombosis, thrombophlebitis
* Active stent carrier less than six months
* Severe forms of arteriosclerosis, arterial circulatory disorders
* Hypertension not treated
* Cardiac arrhythmias
* Hemorrhagic disorders (hemophilia)
* Severe forms of diabetes mellitus
* Known allergy to materials making up the device or its applied parts
* Cancer or tumour disease
* Acute arthritis
* Other neurological diseases other than stroke
* Progressive muscular dystrophy
* Abdominal or inguinal hernias
* Undiagnosed back pain
* Diseases of internal organs

Where this trial is running

Genova and 2 other locations

• Ospedale Policlinico San Martino — Genova, Italy (RECRUITING)
• Fondazione Don Carlo Gnocchi Onlus — La Spezia, Italy (RECRUITING)
• IRCCS Fondazione Don Carlo Gnocchi Onlus — Milan, Italy (RECRUITING)

Study contacts

• Principal investigator: Maurizio Ferrarin, PhD, Eng — IRCCS Fondazione Don Carlo Gnocchi ONLUS
• Study coordinator: Alessandro Viganò, MD, PhD

Conditions: Stroke, EMG-controlled Functional Electrical Stimulation, Stroke rehabilitation, Medical device