Transcranial Direct Current Stimulation and Robotic Therapy in Upper Limb Motor Recovery After Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transcranial Direct Current Stimulation and Robotic Therapy in Upper Limb Motor Recovery After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: tDCS plus wrist robot therapy
* Device: Sham tDCS plus wrist robot therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: persons affected by first supratentorial stroke, whose onset time is 25±7 days; upper limb hemiparesis; cognitive and speech abilities sufficient to understand instructions and to provide informed consent; absence of intense pain due to passive wrist mobilization assessed by VAS < 3 (range 0-10); ability to provide written informed consent. Exclusion Criteria: previous epilepsy seizures; severe electroencephalographic anomalies; previous neurosurgery interventions involving metallic elements placement; ongoing anticonvulsant drugs treatment inability to keep sitting posture; severe sensory deficits; general clinical complication preventing delivery of rehabilitation treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS plus wrist robot therapy<br>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. | Device: tDCS plus wrist robot therapy<br>* Patients receive robotic rehabilitation session while tDCS stimulator is switched on<br>|
| Sham Comparator: Sham tDCS plus wrist robot therapy<br>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. | Device: Sham tDCS plus wrist robot therapy<br>* Patients receive robotic rehabilitation session while tDCS stimulator is switched off.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |