Stroke, Upper Extremity Impairments
Conditions
Brief summary
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.
Interventions
DEVICEreal-tDCS + UE robot-assisted therapy
DEVICEsham-tDCS + UE robot-assisted therapy
Sponsors
University Hospital of Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males and females subjects. Age \> 18 years. * Diagnosis of first ischemic stroke * Impairment of the upper limb * Trunk control defined in the Trunk-Control Test (TCT), with a score \> 50.
Exclusion criteria
* anyone who does not have adequate understanding of verbal or written information in Italian sufficient to complete any test * Impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE) * contraindications to single-pulse transcranial magnetic stimulation (TMS)(TMS will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants) * Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current * Neurological or psychiatric pathology * severe cardio-pulmonary, renal, hepatic diseases * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Upper Extremity | A week prior to treatment beginning | Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Box and Block Test | A week prior to treatment beginning | 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. |
| Ashworth Modified Scale | A week prior to treatment beginning | a 6 point measure of spasticity. We will assess the spasticity at the shoulder, elbow and, wrist |
| Motor Activity Log (MAL) | A week prior to treatment beginning | 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. |
| Assessment of cortical excitability (TMS) | A week prior to treatment beginning | 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 |
Countries
Italy
Outcome results
None listed