The Combining rTMS With Visual Feedback Training for Patients With Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigating the Effects of Combining rTMS With Visual Feedback Training to Improve Movements in the Paretic Lower Limb and Gait Performance

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: rTMS
* Behavioral: visual feedback training
* Behavioral: traditional rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rTMS+visual feedback<br>10-minute rTMS and then a 30-minute visual feedback training ,3 times a week, for 4 weeks | Behavioral: rTMS<br>* 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.<br>Behavioral: visual feedback training<br>* Game-based visual feedback training system and software.The system was designed to enable the subjects to perform ankle movements in multiple axes.<br>|
| Active Comparator: sham rTMS+visual feedback<br>10-minute sham rTMS and then a 30-minute visual feedback training ,3 times a week, for 4 weeks | Behavioral: rTMS<br>* 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.<br>Behavioral: visual feedback training<br>* Game-based visual feedback training system and software.The system was designed to enable the subjects to perform ankle movements in multiple axes.<br>|
| Active Comparator: sham rTMS+traditional training<br>10-minute sham rTMS and then a 30-minute traditional rehabilitation training,3 times a week, for 4 weeks | Behavioral: rTMS<br>* 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.<br>Behavioral: traditional rehabilitation<br>* 30 min traditional rehabilitation. The traditional rehabilitation programs included balance training, postural training, muscle strengthening, ambulation training and etc..<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Motor evoked potential | Measurement of motor evoked potential of anterior tibialis | Change from baseline to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chang of Motor Assessment Score | Lower Limb motor function | Change from baseline to 4 weeks | 
| Chang of Berg Balance Test | standing balance | Change from baseline to 4 weeks | 
| Chang of Fugl-Meyer Assessment-Lower Limb section | Lower Limb section | Change from baseline to 4 weeks | 
| Chang of Modified barthel index | Activity of daily live ability | Change from baseline to 4 weeks | 
| Chang of Time Up and Go | functional ambulation | Change from baseline to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rTMS, visual feedback, gait