Efficacy Study of FES Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients

N/ACompletedNCT03019744

Fondazione Don Carlo Gnocchi Onlus82 enrolled

Overview

Goal of the present study is to evaluate the efficacy of Myoelectrically-controlled Functional Electrical Stimulation (MeCFES) for the rehabilitation of upper limb in post-stroke patients. MeCFES-assisted rehabilitation will be compared with usual care rehabilitation of upper limb. It is hypothesized that that applying MeCFES in rehabilitation to assist normal arm movements during rehabilitation of the upper limb in persons with stroke will improve the movement quality and success and thus induce recovery at the body functions level (impairment) and the activity level (disability) of the International Classification of Function (ICF) superior to that induced by usual care rehabilitation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hemiplegia/hemiparesis due to a first ischemic or haemorrhagic stroke * at least 1 month post-stroke * willingness to participate the project * minimum voluntary muscle activation of shoulder flexors (\>1 Manual Muscle Test) * passive Range of Motion (ROM) of the shoulder and elbow of more than 90° Exclusion Criteria: * epilepsy * severe spasticity at upper limb (\>= 3 Ashworth scale) * implanted electronic device * respiratory insufficiency * pregnancy * peripheral neuropathies * cutaneous ulcers at the stimulation zone * other use of FES on the upper limb

Outcomes

Primary Outcomes

Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment

ARAT: Action Research Arm Test scale (15 item) (see in References section: Van der Lee JH et al 2002). ARAT minimum value is 0 and maximum value is 45. Higher scores mean a better outcome.