Repetitive Arm Training + FES on Upper Extremity Motor Recovery in Sub-acute Stroke Survivors

The Effects of Repetitive Arm Training Combined With Functional Electrical Stimulation on Upper Extremity Motor Recovery in Sub-acute Stroke Survivors

Rehabilitation restores functions and reduces disabilities due to diseases sequelae. The relationship between intensity of rehabilitation and clinical outcomes, recently emphasized, has generated a great interest for technological high-intensity interventions. However, their effects compared to traditional interventions as well the involved biological mechanisms remain uncertain. The present Strategic Program aims to predict the treatment efficacy in specific rehabilitation profiles, to improve the use of "targeted" therapies and the individual management of patients affected by stroke and to transfer these findings into rehabilitative strategies.

Primary endpoint: Fugl-Meyer Upper Extremity (FM-UE) Secondary endpoints: Box and Block Test (BBT), Modified Ashworth Scale (MAS); motor cortex excitability (TMS); Electromyography analysis of muscle activation patterns during upper extremity movements; measurements of cerebral perfusion (NIRS); circulating biomarkers (see Figure 3 and Table 1). Overall assessments will be performed pre-, mid-, post-treatment and at 6-months follow-up.

Inclusion criteria:

• males and females, age 18 to 79 years
• diagnosis of first, single unilateral ischemic stroke verified by brain imaging < 8 weeks
• upper limb motor function defined by an FM-UE score > 11 and <55

Exclusion criteria:

• medical conditions likely to interfere with the ability to safely complete the study protocol
• impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
• severe upper-limb pain, referred as > 7 at Visual Analog Scale (VAS)
• history of seizures or epilepsy