A prospective trial to verify the recovery of upper extremity motor function by applying repetitive transcranial magnetic stimulation to those who need Upper-limb Rehabilitation treatment for subcortical and brain stem stroke(ischemic)
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0007808
- Lead Sponsor
- Remed
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 88
1. Adults between the ages of 19 and 80
2. Patients with an imaging diagnosis with an initial onset of subcortical and brainstem stroke (ischemic) within 90 days of the screening visit
3. Those with a score of more than 15 on the Fugl-Meyer Assessment Scale (Upper Extremity)
4. K-Mini Mental Status Exam (K-MMSE) A person who has enough cognitive ability to understand and follow the instructions of the examiner with a score of 15 or higher
5. Women of childbearing age who have agreed to use one or more of the clinically appropriate methods of contraception during the trial period.
6. Those who voluntarily decided to participate in this clinical trial and agreed in writing to the subject's explanation and consent form
7. A person who is willing to comply with the clinical trial protocol
1. Among the Fugl-Meyer Assessment Scale (Upper Extremity) scores, those with a wrist score less than 1 and a hand score less than 1.
2. Those diagnosed with hemorrhagic stroke
3. Those diagnosed with cerebellar-involving stroke
4. Persons diagnosed with recurrent stroke
5. Persons diagnosed with stroke due to traumatic brain injury
6. Those with a history of cerebrovascular surgery
7. Those who require intensive treatment due to serious complications due to stroke
8. Persons with a history of psychiatric or neurological diseases before the onset of stroke
9. Those who had a disease causing pain or muscle atrophy that prevented the rehabilitation of the upper extremity before the onset of stroke
10. Those with a history of epilepsy or seizure disorders
11. Those who cannot communicate due to aphasia
12. Those with skin lesions in the area to be stimulated
13. A person who has inserted a metal material into the cranial cavity (pacific pacemaker, cerebral aneurysm clip, etc.). However, it is possible for those who have inserted metal materials that are not affected by magnetic fields such as artificial joints and spinal implants.
14. Those who cannot regularly receive physical and occupational therapy for paralyzed upper limbs
15. Those who are currently participating in other clinical trials or have experience participating in other clinical trials within 90 days from the screening date
16. In other cases, when the investigator judges that participation in the clinical trial is inappropriate because it may affect the clinical trial results or ethically
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Box and Block Test (BBT) Number of Changes (pcs)
- Secondary Outcome Measures
Name Time Method Fugl-Meyer Assessment Scale (Upper Extremity) score change (points);Korean version modified Barthel Index (K-mBI) score change (points);NIH Stroke Scale (NIHSS) score change (points);Finger tapping score change (points);Brunnstrom Stage step change;modified Ashworth Scale (MAS) score change (points);Grip Strength (Hand grip, Pinch grip, Lateral prehension, Three jaw chuck) change (lbs)