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

Not Applicable

Completed

• Conditions: Hemiplegia; Stroke, Acute
• Interventions: Device: HF-rTMS; Behavioral: ML; Device: Sham-rTMS

• Registration Number: NCT05176613
• Lead Sponsor: Chungnam National University Sejong Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-13
• Primary Completion: 2016-07-29
• Study Completion: 2016-08-05
• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-15
• Status Verified: 2022-01
• Study First Posted: 2022-01-04
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HF-rTMS and ML	ML	High frequency Repetitive Transcranial Magnetic Stimulation and Motor Learning(Experimental group)
HF-rTMS and ML	HF-rTMS	High frequency Repetitive Transcranial Magnetic Stimulation and Motor Learning(Experimental group)
Sham-rTMS and ML	ML	Sham Repetitive Transcranial Magnetic Stimulation and Motor Learning
Sham-rTMS and ML	Sham-rTMS	Sham Repetitive Transcranial Magnetic Stimulation and Motor Learning

Primary Outcome Measures

Name	Time	Method
Fugl Meyer Assessment - Upper Limb(FMA-U/L)	Change from baseline at the end of four weeks intervention	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.

Secondary Outcome Measures

Name	Time	Method
Box and Block Test(BBT)	Change from baseline at the end of four weeks intervention	The Box and Block Test(BBT) is device to assess upper limb dexterity in stroke patients
Digital hand dynamometer	Change from baseline at the end of four weeks intervention	The 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 intervention	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.