A Phase 2 interventional study of real-tDCS + UE robot-assisted therapy and sham-tDCS + UE robot-assisted therapy in Stroke and Upper Extremity Impairments, sponsored by University Hospital of Ferrara. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-01-16.
Sponsored by University Hospital of Ferrara · Phase 2, Interventional, and Treatment
After stroke a limited motor recovery in the paretic upper limb accounts for a large proportion of the disabling sequelae. Only about 15% of those with initial complete upper limb paralysis after stroke recover functional use of their impaired arm in daily life.
The aim of this study is to test the effects of tDCS combined with upper extremity robot-assisted therapy on stroke survivors.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →University Hospital of Ferrara is the lead sponsor of 113 studies on the registry; 28 are open to participants now.
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This group will receive the same robot-assisted therapy of the intervention group, in association of sham-tDCS. This consists in a 30 seconds stimulation, with the same instrumentation and electrodes placement. This method of sham stimulation was previously validated.
Device: sham-tDCS + UE robot-assisted therapy
This group will receive continuous stimulation lasting 30 minutes during the session of robot-assisted therapy. The training session, which includes multiplanar, repetitive and target reaching movements, will be given 5 times a week for 2 weeks(REO Therapy System; Motorika, Medical LTD, Israel). Each session will last about 30 minutes. Transcranial direct current stimulation (tDCS) will be administered as follows. The anode will be placed on the primary motor cortex (M1) of the affected hemisphere and the cathode on the contralateral M1 area. The direct current is transmitted through a pair of sponge electrodes, with a surface of 35 cm2 (7x5), soaked in saline solution and, it is generated by a constant current stimulator, with rechargeable batteries (Brainstim, EMS, Italy). This continuous stimulation lasted 30 minutes, with an intensity of 1mA.
Device: real-tDCS + UE robot-assisted therapy
Fugl-Meyer Upper Extremity
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.
Time frame: A week prior to treatment beginning
Box and Block Test
Test for gross motor function. It counts the number of blocks that can be transported from one compartment of a box to another compartment within 1 minute.
Time frame: A week prior to treatment beginning
Ashworth Modified Scale
a 6 point measure of spasticity. We will assess the spasticity at the shoulder, elbow and, wrist
Time frame: A week prior to treatment beginning
Motor Activity Log (MAL)
Assessment of the change in real-world arm use in activities of daily living. Subjects are asked to score the quality of movement as well as amount of use of the affected arm in a number of common daily activities.
Time frame: A week prior to treatment beginning
Assessment of cortical excitability (TMS)
MEP of upper limb muscles (first dorsal interosseous) will be recorded with surface EMG electrodes. neurophysiological parameters analyzed: * motor threshold at rest * MEP recruitment curve at rest * MEP amplitude
Time frame: A week prior to treatment beginning
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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