Stroke
Conditions
Brief summary
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
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.
Interventions
DEVICEtDCS plus wrist robot therapy
Patients receive robotic rehabilitation session while tDCS stimulator is switched on
DEVICESham tDCS plus wrist robot therapy
Patients receive robotic rehabilitation session while tDCS stimulator is switched off.
Sponsors
Auxilium Vitae Volterra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. persons affected by first supratentorial stroke, whose onset time is 25±7 days; 2. upper limb hemiparesis; 3. cognitive and speech abilities sufficient to understand instructions and to provide informed consent; 4. absence of intense pain due to passive wrist mobilization assessed by VAS \< 3 (range 0-10); 5. ability to provide written informed consent.
Exclusion criteria
1. previous epilepsy seizures; 2. severe electroencephalographic anomalies; 3. previous neurosurgery interventions involving metallic elements placement; 4. ongoing anticonvulsant drugs treatment 5. inability to keep sitting posture; 6. severe sensory deficits; 7. general clinical complication preventing delivery of rehabilitation treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection) | 6 weeks | Impairment level measure according to ICF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection) | 6 months | Impairment level measure according to ICF |
| Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index | 6 weeks | Impairment level measure according to ICF |
| Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale | 6 weeks | Impairment level measure according to ICF |
| Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test | 6 weeks | Activities level measure according to ICF |
Countries
Italy
Outcome results
None listed