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

Last updated: April 14, 2025
Sponsor: Fondazione Don Carlo Gnocchi Onlus
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

EMG-based FES rehabilitation

Traditional rehabilitation

Clinical Study ID

NCT06928857
RAISE-FITFES-RCT
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 andless than 5 (excluding extremes).

  • Signed informed consent

Exclusion

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, behavioraldisorders, neglect, sensory, visual and auditory disturbances of severe degree orotherwise 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

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: EMG-based FES rehabilitation
Phase:
Study Start date:
March 03, 2025
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Ospedale Policlinico San Martino

    Genova, 16132
    Italy

    Active - Recruiting

  • Fondazione Don Carlo Gnocchi Onlus

    La Spezia, 19125
    Italy

    Active - Recruiting

  • IRCCS Fondazione Don Carlo Gnocchi Onlus

    Milano, 20148
    Italy

    Active - Recruiting

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