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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sham-tDCS + UE robot-assisted therapy | Sham Comparator | 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. |
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| real-tDCS + UE robot-assisted therapy | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| real-tDCS + UE robot-assisted therapy | Device |
| ||
| sham-tDCS + UE robot-assisted therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Upper Extremity | Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66. | A week prior to treatment beginning |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | A week prior to treatment beginning |
| Ashworth Modified Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ferrara University Hospital | Ferrara | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33175411 | Derived | Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Device |
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a 6 point measure of spasticity. We will assess the spasticity at the shoulder, elbow and, wrist
| 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. | 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:
| A week prior to treatment beginning |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |