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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi Onlus

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • EMG-based FES rehabilitation
  • Traditional rehabilitation

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Fondazione Don Carlo Gnocchi Onlus

Lead sponsor

Istituto Italiano di Tecnologia

Collaborator

Ospedale Policlinico San Martino

Collaborator