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The Combining rTMS With Visual Feedback Training for Patients With Stroke (rTMS)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
rTMS
visual feedback training
traditional rehabilitation
Sponsored by
Taipei Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring rTMS, visual feedback, gait

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Monohemispheric ischemic or hemorrhage stroke
  2. Subjects with first-ever stroke 3.6 months after stroke onset

4.The Brunnstrom stage of lower limb >Ⅲ 5.>23 in the mini-mental state exam 6.The Modified Ashworth Scale of lower limb <3 7.Clear consciousness can meet the relevant assessments

Exclusion Criteria:

  1. Recurrent stoke
  2. Severe spasticity of lower limb and difficult to perform isolative movement.
  3. History of seizures or epileptic
  4. Have implanted ferromagnetic devices or other magnetic-sensitive metal implants
  5. Concomitant vestibular and cerebellum diseases
  6. Joint contracture of lower limb/foot and other orthopedic problems
  7. Subjects with severe cognitive impairment
  8. Subjects with depression and/or mood disorder
  9. Presence of any comorbid neurological diseases or psychological diseases

Sites / Locations

  • Taipei Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

rTMS+visual feedback

sham rTMS+visual feedback

sham rTMS+traditional training

Arm Description

10-minute rTMS and then a 30-minute visual feedback training ,3 times a week, for 4 weeks

10-minute sham rTMS and then a 30-minute visual feedback training ,3 times a week, for 4 weeks

10-minute sham rTMS and then a 30-minute traditional rehabilitation training,3 times a week, for 4 weeks

Outcomes

Primary Outcome Measures

Change of Motor evoked potential
Measurement of motor evoked potential of anterior tibialis

Secondary Outcome Measures

Chang of Motor Assessment Score
Lower Limb motor function
Chang of Berg Balance Test
standing balance
Chang of Fugl-Meyer Assessment-Lower Limb section
Lower Limb section
Chang of Modified barthel index
Activity of daily live ability
Chang of Time Up and Go
functional ambulation

Full Information

First Posted
September 27, 2018
Last Updated
January 15, 2023
Sponsor
Taipei Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03689491
Brief Title
The Combining rTMS With Visual Feedback Training for Patients With Stroke
Acronym
rTMS
Official Title
Investigating the Effects of Combining rTMS With Visual Feedback Training to Improve Movements in the Paretic Lower Limb and Gait Performance
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 5, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University Hospital

4. Oversight

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

5. Study Description

Brief Summary
After stroke, patients often experience motor deficits that interrupt normal lower extremity movement and gait function. Recent developments in neuroimaging have focus on the reasons why some patients recover well while some do poorly. However, there is still no consensus on the exact mechanisms involved in regaining the functions after rehabilitation. Application of repetitive transcranial magnetic stimulation (rTMS) to facilitate neural plasticity during stroke treatment has recently gained considerable attention. The possible mechanism through which rTMS acts is based on the interhemispheric competition (IHC) model, which explains that patients with stroke experience alterations in cortical excitability and exhibit abnormally high interhemispheric inhibition from the unaffected hemisphere to the affected hemisphere. The visual feedback training can improve postural control and enhance motor performance. Several rTMS studies have evaluated the lower extremity dysfunction following stroke, but few studies have explored the efficacy of applying rTMS on the lower extremities. We expect the study can help us to further exploration of the change of clinical function and cortical excitability following rTMS and visual feedback training in subjects with stroke. In addition, the results of this project will be provided for further rehabilitation programs in people with stroke.
Detailed Description
Objective: To investigate the effects of combining rTMS with visual feedback training to improve movements in the paretic lower limb and gait performance. Methods: Thirty patients with monohemispheric after ischemic stroke will recruited and randomized into 3 groups. The group 1 received a 10-minute rTMS intervention then a 30-minute visual feedback training. The group 2 received a 10-minute sham rTMS intervention then a 30-minute visual feedback training. The group 3 received a 10-minute sham rTMS intervention then a 30-minute traditional rehabilitation training. All subjects received treatments 3 times a week for 4 weeks. The performance was assessed by a blinded assessor for two times (baseline and after 4 weeks). The outcome measures included Motor evoked potential (MEP), Fugl-Meyer Assessment-Lower Limb section(FMA-LE),Motor Assessment Score(MAS), Berg Balance Test (BBS),Time Up and Go (TUG), and Modified Barthel Index for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at 0.05. The hypothesis is combining rTMS with visual feedback training has positive effects on lower limb and gait performance among patients with stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
rTMS, visual feedback, gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
Outcomes Assessor
Masking Description
Single Blind (Outcomes Assessor)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rTMS+visual feedback
Arm Type
Experimental
Arm Description
10-minute rTMS and then a 30-minute visual feedback training ,3 times a week, for 4 weeks
Arm Title
sham rTMS+visual feedback
Arm Type
Active Comparator
Arm Description
10-minute sham rTMS and then a 30-minute visual feedback training ,3 times a week, for 4 weeks
Arm Title
sham rTMS+traditional training
Arm Type
Active Comparator
Arm Description
10-minute sham rTMS and then a 30-minute traditional rehabilitation training,3 times a week, for 4 weeks
Intervention Type
Behavioral
Intervention Name(s)
rTMS
Intervention Description
The EMG measured the MEPs of the anterior tibialis in response to the TMS delivered using a Magstim Rapid2 stimulator (Magstim Co, Ltd, Carmarthenshire, Wales, UK) with a 70-mm figure-8 coil (maximum power, 2.2 T) over the contralateral M1. The intensity was initially set at 100% of the machine output (MO) to determine the optimal stimulation site (hotspot). The hotspot was marked on the scalp with oil ink and recorded as x, y, in centimeters from the vertex (cz). The participants received real rTMS or sham rTMS, respectively (1 Hz, 10 min), which was before a 30-minute visual feedback training and/or traditional rehabilitation training.
Intervention Type
Behavioral
Intervention Name(s)
visual feedback training
Intervention Description
Game-based visual feedback training system and software.The system was designed to enable the subjects to perform ankle movements in multiple axes.
Intervention Type
Behavioral
Intervention Name(s)
traditional rehabilitation
Intervention Description
30 min traditional rehabilitation. The traditional rehabilitation programs included balance training, postural training, muscle strengthening, ambulation training and etc..
Primary Outcome Measure Information:
Title
Change of Motor evoked potential
Description
Measurement of motor evoked potential of anterior tibialis
Time Frame
Change from baseline to 4 weeks
Secondary Outcome Measure Information:
Title
Chang of Motor Assessment Score
Description
Lower Limb motor function
Time Frame
Change from baseline to 4 weeks
Title
Chang of Berg Balance Test
Description
standing balance
Time Frame
Change from baseline to 4 weeks
Title
Chang of Fugl-Meyer Assessment-Lower Limb section
Description
Lower Limb section
Time Frame
Change from baseline to 4 weeks
Title
Chang of Modified barthel index
Description
Activity of daily live ability
Time Frame
Change from baseline to 4 weeks
Title
Chang of Time Up and Go
Description
functional ambulation
Time Frame
Change from baseline to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Monohemispheric ischemic or hemorrhage stroke Subjects with first-ever stroke 3.6 months after stroke onset 4.The Brunnstrom stage of lower limb >Ⅲ 5.>23 in the mini-mental state exam 6.The Modified Ashworth Scale of lower limb <3 7.Clear consciousness can meet the relevant assessments Exclusion Criteria: Recurrent stoke Severe spasticity of lower limb and difficult to perform isolative movement. History of seizures or epileptic Have implanted ferromagnetic devices or other magnetic-sensitive metal implants Concomitant vestibular and cerebellum diseases Joint contracture of lower limb/foot and other orthopedic problems Subjects with severe cognitive impairment Subjects with depression and/or mood disorder Presence of any comorbid neurological diseases or psychological diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng Hsien-Lin, Master
Organizational Affiliation
Taipei Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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The Combining rTMS With Visual Feedback Training for Patients With Stroke

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