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

Primary Purpose

Stroke, Acute, Hemiplegia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HF-rTMS
ML
Sham-rTMS
Sponsored by
Chungnam National University Sejong Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke, Acute

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    HF-rTMS and ML

    Sham-rTMS and ML

    Arm Description

    High frequency Repetitive Transcranial Magnetic Stimulation and Motor Learning(Experimental group)

    Sham Repetitive Transcranial Magnetic Stimulation and Motor Learning

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Box and Block Test(BBT)
    The Box and Block Test(BBT) is device to assess upper limb dexterity in stroke patients
    Digital hand dynamometer
    The digital hand dynamometer is device to assess hand grip force in stroke patients
    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.

    Full Information

    First Posted
    December 2, 2021
    Last Updated
    January 6, 2022
    Sponsor
    Chungnam National University Sejong Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05176613
    Brief Title
    Effects of High Frequency rTMS Combined Motor Learning on Upper Limb Motor Function in Subacute Stroke
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    May 13, 2016 (Actual)
    Primary Completion Date
    July 29, 2016 (Actual)
    Study Completion Date
    August 5, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chungnam National University Sejong Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Acute, Hemiplegia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HF-rTMS and ML
    Arm Type
    Experimental
    Arm Description
    High frequency Repetitive Transcranial Magnetic Stimulation and Motor Learning(Experimental group)
    Arm Title
    Sham-rTMS and ML
    Arm Type
    Sham Comparator
    Arm Description
    Sham Repetitive Transcranial Magnetic Stimulation and Motor Learning
    Intervention Type
    Device
    Intervention Name(s)
    HF-rTMS
    Other Intervention Name(s)
    High Frequency repetitive Transcranial Magnetic Stimulation(HF-rTMS)
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    ML
    Other Intervention Name(s)
    Motor Learning(ML)
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Sham-rTMS
    Other Intervention Name(s)
    Sham repetitive Transcranial Magnetic Stimulation(Sham-rTMS)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Fugl Meyer Assessment - Upper Limb(FMA-U/L)
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Box and Block Test(BBT)
    Description
    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
    Title
    Digital hand dynamometer
    Description
    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
    Title
    Korean version of the Modified Barthel Index(K-MBI)
    Description
    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

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    JungWoo Shim, master
    Organizational Affiliation
    Chungnam National University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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