Repetitive Arm Training + FES on Upper Extremity Motor Recovery in Sub-acute Stroke Survivors
Stroke, Arm Motor Recovery
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Arm motor recovery, biological biomarkers
Eligibility Criteria
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
Sites / Locations
- Physical Medicine and Rehabilitation Department Ferrara
- Ferrara University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
arm training combined with FES
conventional therapy
Arm training protocol Training sessions will last for 60 minutes and will focus on repetitive tasks that incorporate multidirectional reaching actions. In this robot-assisted therapy a robot manipulator applies forces to the paretic arm during goal-directed movements. Functional electrical stimulation protocol Experimental group will receive up to 40 minutes of FES after arm training. The device consists of a battery powered programmable stimulator and a forearm-wrist-hand orthosis containing 5 electrodes positioned to provide reliable activation of muscles. The intensity of stimulation will be set to a level that provided comfortable and consistent activation of the extensor and flexor muscles to achieve whole hand opening and functional grasping.
The conventional rehabilitation program will consist of physiotherapy sessions (100 min/day) following an individualized approach. The program aims at the restoration of mobility and daily living competence, Specific exercises for the affected upper limb will include, bilateral tasks and facilitation techniques based on neuro-developmental treatment.