Status:
COMPLETED
NIBS With mCIMT for Motor and Functional Upper Limb Recovery in Stroke Patients.
Lead Sponsor:
University of Chile
Collaborating Sponsors:
Comisión Nacional de Investigación Científica y Tecnológica
Hospital San José
Conditions:
Stroke
Upper Extremity Paresis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Stroke is one of the leading causes of serious long-term impairment. According to the estimates, 12,500 people suffer a new or recurrent ischemic stroke in Chile annually, which shows the magnitude of...
Detailed Description
To test this hypothesis, the investigators propose to carry out a sham randomized multicenter double blind clinical trial. This trial considers seven continuous days of treatment when the participants...
Eligibility Criteria
Inclusion
- First unihemispheric stroke event, ischemic or hemorrhagic, cortical or subcortical.
- Hemiparesis with unilateral brachial compromise.
- Evolution time ≥ 2 days. (equal or more than 2 days after onset)
- Patient must be 18 years old or older.
- Showing ability to perform some movement with the upper limb: at least 20º active extension of the wrist and 10º extension in fingers and/or 20° abduction angle in the shoulder.
- Informed consent signed by the patient.
Exclusion
- Previous central injury with motor sequelae.
- Severe aphasia with a score ≥ 2 in the language item of the National Institutes of Health Stroke Scale assessment.
- Severe cognitive impairment with a score \< 15 points in the Mini-mental state examination.
- Shoulder subluxation and/or pain \> 4 points in the Visual Numeric Scale for pain.
- Non-controlled epilepsy or epileptic seizures in the last three months.
- Metal implants or pacemaker.
- Pregnancy.
- Any other condition that, in the responsible physician's opinion, could prevent the correct development of the treatment.
Key Trial Info
Start Date :
June 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03452254
Start Date
June 4 2018
End Date
June 30 2021
Last Update
September 9 2021
Active Locations (2)
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1
Hospital San José
Santiago, Santiago Metropolitan, Chile, 8380419
2
Hospital Clinico Universidad de Chile
Santiago, Santiago Metropolitan, Chile, 8380456