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Effects of High Frequency rTMS Combined Motor Learning on Upper Limb Motor Function in Subacute Stroke

Effects of High Frequency Repetitive Transcranial Magnetic Stimulation Combined Motor Learning on Motor Function and Grip Force for Upper Limbs and Activities of Daily Living in Sub-acute Stroke Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05176613
Enrollment
30
Registered
2022-01-04
Start date
2016-05-13
Completion date
2016-08-05
Last updated
2022-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiplegia, Stroke, Acute

Brief summary

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

Interventions

DEVICEHF-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.

BEHAVIORALML

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.

DEVICESham-rTMS

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.

Sponsors

Chungnam National University Sejong Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Hemiplegia from stroke * Factors within six months of onset * Found to have subcortex damage through diagnoses of magnetic resonance imaging(MRI) * Had motor defects on the damaged upper extremities * Korean version Mini mental state examination(MMSE-K) score greater than 24 points

Exclusion criteria

* Permanent damage such as heart vein * Upper limb fractures * Neurological damage such as Parkinson's, multiple sclerosis * Other reasons limiting upper limb movement * Epilepsy or family history of epilepsy * wearing a metal tube in skull or pacemaker * The lesion at occipital lobe

Design outcomes

Primary

MeasureTime frameDescription
Fugl Meyer Assessment - Upper Limb(FMA-U/L)Change from baseline at the end of four weeks interventionThe 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.

Secondary

MeasureTime frameDescription
Box and Block Test(BBT)Change from baseline at the end of four weeks interventionThe Box and Block Test(BBT) is device to assess upper limb dexterity in stroke patients
Digital hand dynamometerChange from baseline at the end of four weeks interventionThe digital hand dynamometer is device to assess hand grip force in stroke patients
Korean version of the Modified Barthel Index(K-MBI)Change from baseline at the end of four weeks interventionThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026