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The objective of the study is to evaluate the effectiveness of transcranial direct current stimulation (tDCS) integrated with wrist robot-assisted treatment. In detail, the anodal stimulation on the impaired hemisphere will be used associated with a robotic treatment.
As for transcranial direct current stimulation a HDC kit (ATES/EB NEURO, Firenze, Italy) will be used as device. It is a new device generation of stimulator able to provide an effective stimulation pattern.
As robotic device the InMotion wrist robot (Interactive Motion Technologies Inc., Watertown, MA, USA) will be used. It is an end-effector robotic device able to assist as needed the wrist movements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS plus wrist robot therapy | Experimental | In addition to standard rehabilitation treatment Group A will perform daily sessions of wrist robot-assisted treatment in combination with tDCS (30 minutes). During first 20 min of each session the patient receives a direct current stimulation through surface sponge electrodes (35 cm2), 2 milliampere intensity: the anodal electrode is placed on presumed lesional area, the cathodal electrode is placed on the controlateral orbital bone. |
|
| Sham tDCS plus wrist robot therapy | Sham Comparator | Group B is treated as Group A, but tDCS, even if the cap is applied on the patient head, is not activated and no current is delivered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS plus wrist robot therapy | Device | Patients receive robotic rehabilitation session while tDCS stimulator is switched on |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection) | Impairment level measure according to ICF | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection) | Impairment level measure according to ICF | 6 months |
| Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Federico Posteraro, MD | Auxilium Vitae Rehabilitation Centre | Principal Investigator |
| Stefano Mazzoleni, PhD | The BioRobotics Institute, Scuola Superiore Sant'Anna | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auxilium Vitae Rehabilitation Centre | Volterra | 56048 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18843735 | Background | Mehrholz J, Platz T, Kugler J, Pohl M. Electromechanical and robot-assisted arm training for improving arm function and activities of daily living after stroke. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006876. doi: 10.1002/14651858.CD006876.pub2. | |
| 18303984 | Background | Floel A, Rosser N, Michka O, Knecht S, Breitenstein C. Noninvasive brain stimulation improves language learning. J Cogn Neurosci. 2008 Aug;20(8):1415-22. doi: 10.1162/jocn.2008.20098. |
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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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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Sham tDCS plus wrist robot therapy | Device | Patients receive robotic rehabilitation session while tDCS stimulator is switched off. |
|
Impairment level measure according to ICF |
| 6 weeks |
| Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index | Impairment level measure according to ICF | 6 months |
| Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale | Impairment level measure according to ICF | 6 weeks |
| Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale | Impairment level measure according to ICF | 6 months |
| Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test | Activities level measure according to ICF | 6 weeks |
| Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test | Activities level measure according to ICF | 6 months |
| 20042788 | Background | Kang EK, Baek MJ, Kim S, Paik NJ. Non-invasive cortical stimulation improves post-stroke attention decline. Restor Neurol Neurosci. 2009;27(6):645-50. doi: 10.3233/RNN-2009-0514. |
| 21856336 | Background | Marangolo P, Marinelli CV, Bonifazi S, Fiori V, Ceravolo MG, Provinciali L, Tomaiuolo F. Electrical stimulation over the left inferior frontal gyrus (IFG) determines long-term effects in the recovery of speech apraxia in three chronic aphasics. Behav Brain Res. 2011 Dec 1;225(2):498-504. doi: 10.1016/j.bbr.2011.08.008. Epub 2011 Aug 12. |
| 20946060 | Background | Fiori V, Coccia M, Marinelli CV, Vecchi V, Bonifazi S, Ceravolo MG, Provinciali L, Tomaiuolo F, Marangolo P. Transcranial direct current stimulation improves word retrieval in healthy and nonfluent aphasic subjects. J Cogn Neurosci. 2011 Sep;23(9):2309-23. doi: 10.1162/jocn.2010.21579. Epub 2010 Oct 14. |
| 21825004 | Background | Hesse S, Waldner A, Mehrholz J, Tomelleri C, Pohl M, Werner C. Combined transcranial direct current stimulation and robot-assisted arm training in subacute stroke patients: an exploratory, randomized multicenter trial. Neurorehabil Neural Repair. 2011 Nov-Dec;25(9):838-46. doi: 10.1177/1545968311413906. Epub 2011 Aug 8. |
| 31170077 | Derived | Mazzoleni S, Tran VD, Dario P, Posteraro F. Effects of Transcranial Direct Current Stimulation (tDCS) Combined With Wrist Robot-Assisted Rehabilitation on Motor Recovery in Subacute Stroke Patients: A Randomized Controlled Trial. IEEE Trans Neural Syst Rehabil Eng. 2019 Jul;27(7):1458-1466. doi: 10.1109/TNSRE.2019.2920576. Epub 2019 Jun 3. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |