An interventional study of HF-rTMS and ML in Stroke, Acute and Hemiplegia, sponsored by Chungnam National University Sejong Hospital. Completed. Per ClinicalTrials.gov, last updated 2022-01-21.
Sponsored by Chungnam National University Sejong Hospital · Not applicable, Interventional, and Supportive care
This study is to present the effect of a program combining high frequency repetitive transcranial magnetic stimulation with motor learning on upper limb motor function and grip strength and activities of daily motion in patients with subacute stroke.
Purpose : This study was to investigate the effects of high frequency repetitive transcranial magnetic stimulation combined with motor learning effects motor function and grip force for upper limbs and activities of daily living of subacute stroke patients.
Subjects : Thirty individuals with subacute stroke, satisfying the selection criteria, were selected for this study. Subject were randomly allocated into 14 high frequency repetitive transcarnial magnetic stimulation+motor learning group(experimental group), 16 sham repetitive transcranial magnetic stimulation+motor learning group(control group).
Intervention : 12 sessions, 3d/wk, 4week Studies : upper limb functional assessment(FMA-U/L, BBT), hand grip force assessment(disital hand dynamometer), activities daily of living assessment(K-MBI) Evaluation : 1)pre test 2)post test
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Chungnam National University Sejong Hospital is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
High frequency Repetitive Transcranial Magnetic Stimulation and Motor Learning(Experimental group)
Device: HF-rTMS · Behavioral: ML
Sham Repetitive Transcranial Magnetic Stimulation and Motor Learning
Behavioral: ML · Device: Sham-rTMS
HF-rTMS stimulated a 70-mm, 8-shaped coil stimulator (The Magstim Company, UK, 2012) on the damaged cerebral cortex. Prior to the application of HF-rTMS, the motor point was identified that stimulates maximum thresholds on the primary motor cortex, causing flexion of the opposite index finger. If the cerebral hemisphere does not show a kinetic response even at the maximum stimulus, the motor point of the opposite hemisphere was found to be symmetrically changed. The intensity of the stimulus was 80% of the resting motor threshold, which means the motor eveked potential above which the first dorsal interosseous muscle can produce 50 μV more than five times out of 10 stimuli. The subject sat on a chair made to hold the head. The stimulation was stimulated at high frequency (10 Hz) for 2 seconds, and the rest was performed for 58 seconds for a total of 200 times for 10 minutes.
Also known as: High Frequency repetitive Transcranial Magnetic Stimulation(HF-rTMS)
Motor learning was conducted for two minutes each in five sessions, and the first is the external rotation training to maximum range of the shoulder joint in sitting position. The second method is to stack cups by transferring them from the non-affected side to the affected side by transferring 25 plastic cups of five colors in sitting position with both hands inserted. Third, by pushing and pulling the ball forward and backward with the hands folded, the subject puts a 55 cm healing ball on the table in a sitting position, and pushes and pulls it forward with the upper limb. The fourth method is to insert and remove pegs from the peg board, and the target uses the affected side hand in sitting position. The fifth method is to tear a newspaper, in which the subject overlaps a newspaper on the table in a sitting position, holds it with the non-affected hand, and tears it with the hands of the damage. A total of 10 minutes of motor learning.
Also known as: Motor Learning(ML)
Sham rTMS gives a small intensity of 2% of the resting motor threshold that cannot cause excitement in the motor cortex, and is set to listen to the same frequency of noise as HF-rTMS, and motor learning is applied equally. A total of 20 minutes were applied three times a week for four weeks by applying 10 minutes of Sham rTMS and 10 minutes of motor learning.
Also known as: Sham repetitive Transcranial Magnetic Stimulation(Sham-rTMS)
Fugl Meyer Assessment - Upper Limb(FMA-U/L)
The FMA-U/L score is a tool for evaluating the body's structure, function, and activity level as an evaluation tool for evaluating motor function according to Brunnstrom's recovery phase of Step 6. The minimum value is 0 point and the maximum value is 66 points, and the higher the score, the better the outcome.
Time frame: Change from baseline at the end of four weeks intervention
Box and Block Test(BBT)
The Box and Block Test(BBT) is device to assess upper limb dexterity in stroke patients
Time frame: Change from baseline at the end of four weeks intervention
Digital hand dynamometer
The digital hand dynamometer is device to assess hand grip force in stroke patients
Time frame: Change from baseline at the end of four weeks intervention
Korean version of the Modified Barthel Index(K-MBI)
The Korean version of the Modified Barthel Index (K-MBI) is a functional change sensitive evaluation tool. The minimum value is 0 point and the maximum value is 100 points, and the higher the score, the better the outcome.
Time frame: Change from baseline at the end of four weeks intervention
No study locations are listed for this record.
Plan to share: No
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Chungnam National University Sejong Hospital