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
About this trial
This is an interventional supportive care trial for Stroke, Acute
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
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
NCT ID
NCT05176613
First Posted
December 2, 2021
Last Updated
January 6, 2022
Sponsor
Chungnam National University Sejong Hospital
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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