self-modulated functional electrical stimulation in chronic stroke patients with severe and moderate upper limb paresis

Conditions: Stroke Rehabilitation

Summary: the study aims at demonstrating the efficacy of self-modulated functional electrical stimulation (sm-fes) in promoting upper-limb (ul) motor recovery in chronic stroke patients with severe and severe-moderate paralysis. the effect of such experimental therapy will be compared to dose-matched, goal-oriented standard care (sc). sm-fes consists of intensive, goal-oriented, repetitive functional exercises assisted by electrical stimulation. the patient actively self-administers the electrical stimulation on the impaired limb by controlling the electrical stimulation device with the non-impaired hand. the duration of the intervention is 90 min per day, 5 days per week, for 2 weeks.

after the informed consent process, each centre will screen potential participants according to the inclusion and exclusion criteria. each recruited participant will be randomly assigned to one group: * experimental group - patients will receive self-modulated functional electrical stimulation sm-fes; * control group - patients will receive standard care sc. this first main phase of the study includes 10 days intervention delivered to the two groups and assessments pre-intervention, post-intervention and after 3 months (follow-up). after the follow-up, participants initially recruited in the control group will be able to enter a secondary exploratory phase and receive further 10 days of treatment with sm-fes.

Eligibility criteria:
inclusion criteria: * diagnosis of one, first-ever ischemic stroke verified by brain imaging (i.e. computed tomography or magnetic resonance imaging); * chronic impairment after stroke, i.e. time since event ≥ 6months; * severe and severe-moderate upper limb impairment, i.e. fma-ue score ≤ 34; * 18 ≤ age \< 80; * ability to give consent, understand the device use and follow instructions. exclusion criteria: * an unstable recovery stage, measured as a difference between screening and baseline examinations of more than 3 points in the motor part of the fma-ue scale; * contraindications and risk factors to neuromuscular electrical stimulation; * severe hemi-spatial neglect or anosognosia involving the affected arm, as determined by the bells tests (\> 6 errors); * severe impairment of proprioception, as evaluated from the blinded detection and discrimination of imposed passive movements (≥ 20° extension or flexion) of the finger proximal joint (\>3 errors out of 6 mobilisations); * severe impairment of tactile sensing in the hand, as assessed by semmes-weinstein monofilament test (no detection of the 5.88 size evaluator); * excessive spasticity, as indicated by a score \> 2 in any of the items of the resistance to passive movement (repas) arm subtest; * recurrent, moderate to high upper limb pain limiting delivery of rehabilitation dose, i.e. pain at rest and in correspondence of a passive range of motion lower than 50%; * botulinum toxin injection into affected upper extremity during 3 months before the study or during the study; * history of physical / medical conditions interfering with study procedure, for example shoulder subluxation, upper extremity injury that limits the function of the hand or arm, skin lesion/rash/open wound on the affected upper extremity, or similar; * history of neurological condition interfering with study procedure, e.g. parkinson's disease, progressive brain diseases like dementia and tumours; * use of antipsychotic medications; * enrolled in the past six months in another study involving drugs, biologics, upper limb experimental therapy, or similar.

Keywords: electrical stimulation upper limb rehabilitation hemiplegia