ISRCTN10150672
Suspended
未知
A neurorehabilitation therapy based on a brain machine interface (BMI) for the motor function restoration of the upper limb in chronic stroke patients: Intracranial Stroke MOtor REhabilitation
Instituto de Investigación Sanitaria Biodonostia (Spain)0 sites6 target enrollmentMay 7, 2015
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Chronic stroke patients with severely paralyzed upper-limb
- Sponsor
- Instituto de Investigación Sanitaria Biodonostia (Spain)
- Enrollment
- 6
- Status
- Suspended
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Assessment of physical and psychological function and impairment:
- •1\. Wolf\-Motor test
- •2\. Goal Attainment Scale (GAS)
- •3\. Motor Activity Log
- •4\. KVIQ\-20
- •5\. Modified Ashworth scales (spasticity)
- •6\. Beck Depression Inventory (BDI)
- •7\. Hamilton Depression Rating Scale (HDRS)
- •8\. Berlin Social Support Scale (BSSS)
- •9\. The Schedule for the Evaluation of the Individual Quality of Life\-Direct Weighting (SEIQoL\-DW) (quality of life)
Exclusion Criteria
- •1\. Drug and/or alcohol abuse
- •2\. Psychiatric disorder (including post\-stroke depression)
- •3\. Cerebellar damage
- •4\. Bilateral motor deficit
- •5\. Uncontrolled health problems (coronary heart disease, severe heart failure in stage III\-IV according to NYHA, severe cardiac arrhythmia, severe edema, severe arthritis, malignant tumor, chronic renal failure)
- •6\. Cognitive impairment (Mini Mental State below 23/30 points). Patients with cognitive or language difficulties that will prevent them giving informed consent and/or follow instructions
- •7\. Pregnancy
- •8\. Drug\-resistant epilepsy
- •9\. Pacemakers, metallic implants (ferromagnetic) or claustrophobia, contraindications to undergo magnetic resonance imaging (MRI)
Outcomes
Primary Outcomes
Not specified
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