Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of stroke is more dramatic in low- and middle- income countries, and the scarcity of evidence-based rehabilitation interventions represents a major challenge to global health care. Upper limb weakness is frequent after stroke, but there is no universally accepted treatment to effectively improve hand function in patients with moderate and severe motor impairment. These are the patients in deepest need of rehabilitative interventions. This project addresses this important issue, by testing effects of a novel approach. The investigators will non-invasively stimulate peripheral nerves in order to enhance effects of motor training aided by an electrical stimulation device in patients with moderate to severe hand weakness. Our hypothesis is that peripheral nerve stimulation will enhance effects of motor training in patients in the chronic stage after stroke.
The objective of this protocol is to determine whether a neuromodulation intervention associated with functional electrical stimulation, when combined with task-specific training over several sessions, decreases upper limb motor disability, motor impairment, overall disability and improves quality of life compared to the sham intervention and functional electrical stimulation.
The interventions will consist of three sessions per week, over six weeks, of outpatient functional electrical stimulation of the paretic wrist and task-specific training. In each session, either active peripheral nerve stimulation (PNS) or sham PNS will be applied. Before the first session, patients will be familiarized with the procedures.
- PNS Procedure
Other Names: Peripheral Nerve Stimulation Intervention Desc: Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator. In sham PNS, the median, ulnar and radial nerves will not be actively stimulated. ARM 1: Kind: Experimental Label: Active PNS Description: Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator. ARM 2: Kind: Experimental Label: Sham PNS Description: In sham PNS, the median, ulnar and radial nerves will not be actively stimulated.
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Wolf Motor Function Test||6 weeks||No|
|Secondary||Motor Activity Log||18 weeks||No|
|Secondary||Active range of motion of wrist extension in the paretic side||18 weeks||No|
|Secondary||Active range of motion of wrist flexion in the paretic side||18 weeks||No|
|Secondary||Grasp force in the paretic side||18 weeks||No|
|Secondary||Grip force in the paretic side||18 weeks||No|
|Secondary||Fugl-Meyer Assessment of Sensorimotor Recovery||18 weeks||No|
|Secondary||Barthel Index||18 weeks||No|
|Secondary||Stroke Impact Scale||18 weeks||No|
|Secondary||Beck Depression Inventory-short Form||18 weeks||No|
|Secondary||Modified Rankin Scale||18 weeks||No|
|Secondary||NIH Stroke Scale||18 weeks||No|