Study on the Effects of an EMG-controlled Functional Electrical Stimulator for Upper Limb for Post-stroke Patients

Don Carlo Gnocchi Onlus Foundation

Status: Enrolling

Conditions: Stroke

Treatments: Device: EMG-based FES rehabilitation; Other: Traditional rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06928857

RAISE-FITFES-RCT

Details and patient eligibility

About

Upper limb disabilities are among the most debilitating issues after a cerebral stroke. One promising approach in motor rehabilitation is the use of functional electrical stimulation (FES). This technique can be integrated into daily therapy to follow an adaptive approach, exploiting the residual capacities of patients. FES can help to stimulate the affected muscles, improve coordination and strengthen the weakened muscles, thus supporting the rehabilitation process.

Full description

FitFES is a wearable and non-invasive device that provides continuous stimulation set according to the residual myoelectric activity of hemiparetic muscles. Its bioinspired functioning has been implemented to restore the neurophysiological feedback from the muscles to the central nervous system while performing voluntary movements. This study aims to assess the effects of FitFES device on upper limb motor rehabilitation of post-stroke subjects, compared to traditional rehabilitation treatment. 50 post-stroke subjects will be recruited and randomized into an experimental group and a control group.

All participants will follow a 15-session rehabilitation program, and in each session they will execute task-oriented exercises. The experimental group will be assisted by the FitFES device, while the control group will perform the tasks without the device support.

Each subject will be assessed before and at the end of the rehabilitation protocol. Collected data from both groups will then be compared.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

FES group

Experimental group

Description:

Subjects will use the device as need-based support to perform task-oriented exercises

Treatment:

Device: EMG-based FES rehabilitation

CON group

Active Comparator group

Description:

Subjects will perform task-oriented exercises without the support of the device

Treatment:

Other: Traditional rehabilitation