The effect of bihemispheric transcranial direct current stimulation combined with routine physiotherapy on the motor function of upper limb in the ischemic stroke patients with hemiplegia
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Protocol summary
the potentiated effects of concurrent routine physiotherapy and transcranial direct current stimulation in the ischemic stroke patients with hemiplegia.
The therapeutic effect of tDCS combined with routine physiotherapy on the neurological and upper limb motor function in ischemic stroke patients with hemiplegia.
the potentiated effectsThe therapeutic effect of concurrenttDCS combined with routine physiotherapy on the neurological and transcranial direct current stimulationupper limb motor function in the ischemic stroke patients with hemiplegia.
بررسی اثر تقویت کننده فیزیوتراپی روتین همراه با تحریک جریان مستقیم فراجمجمه ای در بیماران استروک ایسکمیک با همی پلژی
تاثیر درمانی تحریک جریان مستقیم فراجمجمه ای مغز بهمراه فیزیوتراپی روتین بر عملکردهای حرکتی اندام فوقانی و عصبی در بیماران استروک ایسکمیک با همی پلژی
بررسی اثر تقویت کننده فیزیوتراپی روتین همراه باتاثیر درمانی تحریک جریان مستقیم فراجمجمه ای مغز بهمراه فیزیوتراپی روتین بر عملکردهای حرکتی اندام فوقانی و عصبی در بیماران استروک ایسکمیک با همی پلژی
A randomized double blind clinical trial,randomized with sealed envelope software,on 50 patients of ischemic stroke with hemiplegia,every group includes 25 individual.
In a randomized double-blind clinical trial, randomized with sealed envelope software, on 52 patients of ischemic stroke with hemiplegia, every group includes 26 individuals.
AIn a randomized double-blind clinical trial,randomizedtrial, randomized with sealed envelope software,on 50software, on 52 patients of ischemic stroke with hemiplegia,everyhemiplegia, every group includes 25 individual26 individuals.
مطالعه کارآزمایی بالینی دو سو کور تصادفی شده با نرم افزار sealed envelope, روی 50 بیمار با استروک ایسکمیک با همی پلژی ، هر گروه شامل 25 نفر.
مطالعه کارآزمایی بالینی دو سو کور تصادفی شده با نرم افزار sealed envelope, روی 52 بیمار با استروک ایسکمیک با همی پلژی ، هر گروه شامل 26 نفر.
مطالعه کارآزمایی بالینی دو سو کور تصادفی شده با نرم افزار sealed envelope, روی 5052 بیمار با استروک ایسکمیک با همی پلژی ، هر گروه شامل 2526 نفر.
Inclusion criteria:
age:18-65 years,unilateral ischemic stroke in middle cerebral artery,upper limb plegia,stroke onset and intervention starting interval from 2 weeks to 1 month,National institute of health stroke scale less than 20
Exclusion criteria:
Conditions which are not compatible to safety guidelines of brain stimulation.Contraindications with transcranial stimulation.
taking psychoactive drugs and CNS effective drugs except tissue plasminogen activator and medications used for stroke routine treatment.
substance abusers,Concurrent psychiatric and other non-stroke neurological disease,The use of calcium and sodium channel blockers,scalp eczema, clinical instability.
Inclusion criteria:
age:18-65 years, unilateral ischemic stroke in middle cerebral artery, paralyzed upper limb, time post-stroke from 2 weeks to 1 month, NIHSS than 20
Exclusion criteria:
taking CNS-effective drugs except for TPA and medications used for stroke routine treatment. A history of prior stroke and other non-stroke neurological diseases, clinical instability, no compatibility with safety guidelines of tDCS
Inclusion criteria: age:18-65 years,unilateralyears, unilateral ischemic stroke in middle cerebral artery,upperartery, paralyzed upper limb plegia,stroke onset and intervention starting interval, time post-stroke from 2 weeks to 1 month,National institute of health stroke scale lessmonth, NIHSS than 20 Exclusion criteria: Conditions which are not compatible to safety guidelines of brain stimulation.Contraindications with transcranial stimulation. taking psychoactive drugs and CNS-effective drugs except tissue plasminogen activatorfor TPA and medications used for stroke routine treatment. substance abusers,Concurrent psychiatricA history of prior stroke and other non-stroke neurological disease,The use of calcium and sodium channel blockers,scalp eczemadiseases, clinical instability., no compatibility with safety guidelines of tDCS
معیارهای ورود: سن بین 18 تا 65 سال ، استروک ایسکمیک یکطرفه شریان مغزی میانی، پلژی اندام فوقانی ، فاصله بین شروع استروک و مداخله بین دو هفته تا یک ماه، نمره مقیاس استروک موسسه ی ملی سلامت کمتر از 20
معیارهای خروج:
شرایطی که مطابق با گاید لاین های ایمنی تحریک مغزی نباشد ، مواردی که با تحریک فراجمجمه ای کنترااندیکاسیون دارد . مصرف داروهای سایکواکتیو و داروهای موثر بر سیستم عصبی مرکزی به غیر از فعال کننده ی پلاسمینوژن بافتی و داروهایی که برای درمان روتین استروک مصرف شده است . سوء مصرف مواد مخدر ، وجود همزمان بیماری های سایکیاتریک و نورولوژیک غیر از استروک ، مصرف دارو های بلوک کننده کانال های سدیم و کلسیم ، اگزمای پوست سر ، بی ثباتی بالینی.
معیارهای ورود: سن بین 18 تا 65 سال ، استروک ایسکمیک یکطرفه در جریان مغز میانی، فلج اندام فوقانی ،زمان پس از استروک بین دو هفته تا یک ماه، نمره مقیاس استروک موسسه ی ملی سلامت کمتر از 20
معیارهای خروج:
مصرف داروهای موثر بر سیستم عصبی مرکزی به غیر از فعال کننده ی پلاسمینوژن بافتی و داروهایی که برای درمان روتین استروک مصرف شده است . سابقه استروک قبلی و سایر اختلالات نورولوژیک غیر از استروک ، بی ثباتی بالینی. مغایرت با خطی مشی ایمنی تحریک فراجمجمه ای
معیارهای ورود: سن بین 18 تا 65 سال ، استروک ایسکمیک یکطرفه شریان مغزیدر جریان مغز میانی، پلژیفلج اندام فوقانی ، فاصله بین شروعزمان پس از استروک و مداخله بین دو هفته تا یک ماه، نمره مقیاس استروک موسسه ی ملی سلامت کمتر از 20 معیارهای خروج: شرایطی که مطابق با گاید لاین های ایمنی تحریک مغزی نباشد ، مواردی که با تحریک فراجمجمه ای کنترااندیکاسیون دارد . مصرف داروهای سایکواکتیو و داروهای موثر بر سیستم عصبی مرکزی به غیر از فعال کننده ی پلاسمینوژن بافتی و داروهایی که برای درمان روتین استروک مصرف شده است . سوء مصرف مواد مخدر ، وجود همزمان بیماری های سایکیاتریکسابقه استروک قبلی و سایر اختلالات نورولوژیک غیر از استروک ، مصرف دارو های بلوک کننده کانال های سدیم و کلسیم ، اگزمای پوست سر ، بی ثباتی بالینی. مغایرت با خطی مشی ایمنی تحریک فراجمجمه ای
'' intervention group'' : real transcranial current stimulation with intensity of 1.5 mA plus routine physiotherapy, 10 sessions,5 successive sessions each week ,30 minutes every session
''control group'' : Sham transcranial stimulation without real stimulation plus routine physiotherapy,10 sessions ,30 minutes every session
'' intervention group'': real transcranial current stimulation plus routine physiotherapy,
''control group'' : Sham transcranial stimulation plus routine physiotherapy
'' intervention group'': real transcranial current stimulation with intensity of 1.5 mA plus routine physiotherapy, 10 sessions,5 successive sessions each week ,30 minutes every session ''control group'' : Sham transcranial stimulation without real stimulation plus routine physiotherapy,10 sessions ,30 minutes every sessionphysiotherapy
"گروه مداخله": تحریک الکتریکی فراجمجمه ای واقعی با شدت 1.5 میلی آمپر همراه فیزیوتراپی روتین، 10 جلسه،هفته ای 5 جلسه ی متوالی، هر جلسه 30 دقیقه
"گروه کنترل": تحریک فراجمجمه ای شم بدون تحریک واقعی همراه فیزیوتراپی روتین،10 جلسه هر جلسه 30 دقیقه
"گروه مداخله": تحریک الکتریکی فراجمجمه ای واقعی همراه فیزیوتراپی روتین
"گروه کنترل": تحریک فراجمجمه ای شم همراه فیزیوتراپی روتین
"گروه مداخله": تحریک الکتریکی فراجمجمه ای واقعی با شدت 1.5 میلی آمپر همراه فیزیوتراپی روتین، 10 جلسه،هفته ای 5 جلسه ی متوالی، هر جلسه 30 دقیقه "گروه کنترل": تحریک فراجمجمه ای شم بدون تحریک واقعی همراه فیزیوتراپی روتین،10 جلسه هر جلسه 30 دقیقه
motor function of upper limb based on WMFT test,stroke deficit severity based on NIHSS score
motor function of upper limb based on MRC, stroke deficit severity based on NIHSS score
motor function of upper limb based on WMFT test,strokeMRC, stroke deficit severity based on NIHSS score
مقدار فانکشن حرکتی اندام فوقانی مطابق با نمره آزمون WMFT ,
شدت نقایص نورولوژیک مطابق با نمره NIHSS
مقدار عملکرد حرکتی اندام فوقانی مطابق با نمره آزمون MRC,
شدت نقایص نورولوژیک مطابق با نمره NIHSS
مقدار فانکشنعملکرد حرکتی اندام فوقانی مطابق با نمره آزمون WMFT MRC, شدت نقایص نورولوژیک مطابق با نمره NIHSS
General information
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2021-01-01, 1399/10/12
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2021-03-19, 1399/12/29
2021-06-01, 1400/03/11
2021-0306-1901 00:00:00
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2021-12-21, 1400/09/30
2021-12-21 00:00:00
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2022-06-25, 1401/04/04
2022-06-25 00:00:00
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2022-09-25, 1401/07/03
2022-09-25 00:00:00
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Reporting the study progression and dates update
Reporting the study progression and dates update
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گزارش پیشرفت مطالعه و به روز رسانی تاریخ ها
گزارش پیشرفت مطالعه و به روز رسانی تاریخ ها
Health conditions studied
#1
patients with unilateral ischemic stroke having paralysis of upper limb
patients with unilateral ischemic stroke having a paralyzed upper limb
patients with unilateral ischemic stroke having paralysis ofa paralyzed upper limb
بیماران با استروک ایسکمیک یکطرفه با پلژی اندام فوقانی
بیماران با استروک ایسکمیک یکطرفه با فلج اندام فوقانی
بیماران با استروک ایسکمیک یکطرفه با پلژیفلج اندام فوقانی
Primary outcomes
#1
فانکشن حرکتی اندام فوقانی
عملکرد حرکتی اندام فوقانی
فانکشنعملکرد حرکتی اندام فوقانی
base line, before intervention, final session of intervention
baseline/before intervention, the final session of intervention, three months after final therapy
base line, baseline/before intervention, the final session of intervention, three months after final therapy
خط پایه، قبل از درمان , آخرین جلسه درمان
خط پایه/ قبل از درمان , آخرین جلسه درمان و سه ماه بعد از پایان درمان
خط پایه،/ قبل از درمان , آخرین جلسه درمان و سه ماه بعد از پایان درمان
Wolf motor function test
Medical Research Council Scale for Muscle Strength (MRC)
Wolf motor function testMedical Research Council Scale for Muscle Strength (MRC)
تست فانکشن حرکتی ولف
مقیاس شورای تحقیقات پزشکی برای قدرت عضله
تست فانکشن حرکتی ولفمقیاس شورای تحقیقات پزشکی برای قدرت عضله
Secondary outcomes
#1
base line and final session of intervention
baseline and final session of intervention, three months after final therapy
base linebaseline and final session of intervention, three months after final therapy
خط پایه و بعد از آخرین جلسه مداخله
خط پایه و بعد از آخرین جلسه مداخله، سه ماه بعد از پایان درمان
خط پایه و بعد از آخرین جلسه مداخله، سه ماه بعد از پایان درمان
National institude of health stroke scale
National institute of health stroke scale (NIHSS)
National institudeinstitute of health stroke scale (NIHSS)
Recruitment centers
#1
Name of recruitment center - English: Poursina hospital, physiotherapy unit
Name of recruitment center - Persian: واحد فیزیوتراپی- بیمارستان پورسینا
Full name of responsible person - English: Arezoo Karimzadeh
Full name of responsible person - Persian: آرزو کریم زاده
Street address - English: Namjou avenue, Poursina junction, Poursina hospital, Neuroscience research center
Street address - Persian: خیابان نامجو، بیمارستان پورسینا. مرکز تحقیقات پورسینا
City - English: Rasht
City - Persian: رشت
Province: Guilan
Country: Iran (Islamic Republic of)
Postal code: 4193713194
Phone: +98 13 3336 8773
Fax: +98 13 3336 8773
Email: arezoo.krz.ak@gmail.com
Web page address: http://www.gums.ac.ir/gnsrc/9008/%D8%B5%D9%81%D8%AD%D9%87-%D8%A7%D8%B5%D9%84%DB%8C.aspx
Name of recruitment center - English: Poursina hospital
Name of recruitment center - Persian: بیمارستان پورسینا
Full name of responsible person - English: Sara Ramezani
Full name of responsible person - Persian: سارا رمضانی
Street address - English: Neuroscience research center,Poursina hospital,Namjoo avenue
Street address - Persian: خیابان نامجو، بیمارستان پورسینا ، مرکز تحقیقات علوم اعصاب
City - English: Rasht
City - Persian: رشت
Province: Guilan
Country: Iran (Islamic Republic of)
Postal code: 4193713194
Phone: +98 911 833 2694
Fax:
Email: s.ramezanislp@gmail.com
Web page address: http://www.gums.ac.ir/gnsrc
Name of recruitment center - English: Poursina hospital, physiotherapy unit Name of recruitment center - Persian: واحد فیزیوتراپی- بیمارستان پورسینا Full name of responsible person - English: Arezoo KarimzadehSara Ramezani Full name of responsible person - Persian: آرزو کریم زادهسارا رمضانی Street address - English: Namjou avenue, Poursina junction, Poursina hospital, Neuroscience research centercenter,Poursina hospital,Namjoo avenue Street address - Persian: خیابان نامجو، بیمارستان پورسینا. ، مرکز تحقیقات پورسیناعلوم اعصاب City - English: Rasht City - Persian: رشت Province: Guilan Country: Iran (Islamic Republic of) Postal code: 4193713194 Phone: +98 13 3336 8773911 833 2694 Fax: +98 13 3336 8773 Email: arezoo.krz.aks.ramezanislp@gmail.com Web page address: http://www.gums.ac.ir/gnsrc/9008/%D8%B5%D9%81%D8%AD%D9%87-%D8%A7%D8%B5%D9%84%DB%8C.aspx
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Guilan university of medical sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی گیلان
Full name of responsible person - English: Arezoo Karimzadeh
Full name of responsible person - Persian: آرزو کریم زاده
Street address - English: Namjou avenue, Poursina junction, Poursina hospital, neuroscience research center
Street address - Persian: خیابان نامجو، چهاراه پورسینا. بیمارستان پورسینا. مرکز تحقیقات نوروساینس
City - English: Rasht
City - Persian: رشت
Province: Guilan
Country: Iran (Islamic Republic of)
Postal code: 331441937
Phone: +98 13 3333 8373
Fax: +98 13 3333 8373
Email: arezoo.krz.ak@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Guilan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی گیلان
Full name of responsible person - English: Mohammad Taghi Ashoobi
Full name of responsible person - Persian: محمدرضا نقی پور
Street address - English: Vice President of Management and Resources Development- Parastar Ave – Rasht- Iran
Street address - Persian: ایران-رشت - خیابان پرستار - معاونت توسعه مدیریت و منابع
City - English: Rasht
City - Persian: رشت
Province: Guilan
Country: Iran (Islamic Republic of)
Postal code: 6694941446
Phone: +98 13 3333 8373
Fax: +98 13 3333 5821
Email: ashoobi@gums.ac.ir
Web page address: http://www.gums.ac.ir/research
contact.organization_id: Name of organization / entity - English: Guilan universityUniversity of medical sciencesMedical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی گیلان Full name of responsible person - English: Arezoo KarimzadehMohammad Taghi Ashoobi Full name of responsible person - Persian: آرزو کریم زادهمحمدرضا نقی پور Street address - English: Namjou avenue, Poursina junction, Poursina hospital, neuroscience research centerVice President of Management and Resources Development- Parastar Ave – Rasht- Iran Street address - Persian: ایران-رشت - خیابان نامجو، چهاراه پورسینا. بیمارستان پورسینا. مرکز تحقیقات نوروساینسپرستار - معاونت توسعه مدیریت و منابع City - English: Rasht City - Persian: رشت Province: Guilan Country: Iran (Islamic Republic of) Postal code: 3314419376694941446 Phone: +98 13 3333 8373 Fax: +98 13 3333 83735821 Email: arezoo.krz.akashoobi@gmail.comgums.ac.ir Web page address: http://www.gums.ac.ir/research
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98042925
98042925
Deputy of research and technology at Guilan University of Medical Sciences
Deputy of research and technology at Guilan University of Medical Sciences
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی گیلان
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی گیلان
Rasht University of Medical Sciences
Guilan University of Medical Sciences
RashtGuilan University of Medical Sciences
دانشگاه علوم پزشکی رشت
دانشگاه علوم پزشکی گیلان
دانشگاه علوم پزشکی رشت گیلان
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Zoheir Reihanian
Full name of responsible person - Persian: ظهیر ریحانیان
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: specialist
Area of specialty/work: 37
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: neuroscience research center,Poursina Hospital,Namjou Ave
Street address - Persian: خیابان نامجو, بیمارستان پورسینا ,مرکز تحقیقات علوم اعصاب
City - English: Rasht
City - Persian: رشت
Province: Guilan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4193713194
Phone: +98 13 3333 8773
Mobile: +98 911 183 6473
Fax:
Email: zoheir.reihanian@gmail.com
Web page address: http://www.gums.ac.ir/gnsrc
contact.organization_id:
Name of organization / entity - English: Guilan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی گیلان
Full name of responsible person - English: Babak Bakhshayesh
Full name of responsible person - Persian: بابک بخشایش
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: specialist
Area of specialty/work: 86
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: neuroscience research center,Poursina Hospital,Namjou Ave
Street address - Persian: خیابان نامجو, بیمارستان پورسینا ,مرکز تحقیقات علوم اعصاب
City - English: Rasht
City - Persian: رشت
Province: Guilan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4193713194
Phone: +98 13 3333 8773
Mobile: +98 911 338 2747
Fax:
Email: babak.bakh@gmail.com
Web page address: http://www.gums.ac.ir/gnsrc
contact.organization_id: Name of organization / entity - English: Guilan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی گیلان Full name of responsible person - English: Zoheir ReihanianBabak Bakhshayesh Full name of responsible person - Persian: ظهیر ریحانیانبابک بخشایش Position - English: AssistantAssociate professor Position - Persian: استادیاردانشیار Latest degree: specialist Area of specialty/work: 3786 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: neuroscience research center,Poursina Hospital,Namjou Ave Street address - Persian: خیابان نامجو, بیمارستان پورسینا ,مرکز تحقیقات علوم اعصاب City - English: Rasht City - Persian: رشت Province: Guilan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 4193713194 Phone: +98 13 3333 8773 Mobile: +98 911 183 6473338 2747 Fax: Email: zoheir.reihanianbabak.bakh@gmail.com Web page address: http://www.gums.ac.ir/gnsrc
Sharing plan
yes
undecided
yesundecided
yes
undecided
yesundecided
yes
undecided
yesundecided
yes
undecided
yesundecided
yes
undecided
yesundecided
yes
undecided
yesundecided
yes
undecided
yesundecided
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there is no additional data
there is no additional data
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اطلاعات بیشتری وجود ندارد
اطلاعات بیشتری وجود ندارد
Some information related to main outcome are provided
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Some information related to main outcome are provided
بعضی اطلاعات مربوط به پیامد اصلی مطالعه به اشتراک گذاشته میشود
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بعضی اطلاعات مربوط به پیامد اصلی مطالعه به اشتراک گذاشته میشود
6 months after summary data are published
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6 months after summary data are published
شروع دوره دسترسی 6 ماه پس از چاپ نتایج
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شروع دوره دسترسی 6 ماه پس از چاپ نتایج
only academic researchers
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only academic researchers
فقط محققین دانشگاهی
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فقط محققین دانشگاهی
for the therapeutic decision making in clinic
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for the therapeutic decision making in clinic
برای استفاده در تصمیم گیری درمانی در کلینیک
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برای استفاده در تصمیم گیری درمانی در کلینیک
s.ramezanislp@gmail.com
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s.ramezanislp@gmail.com
s.ramezanislp@gmail.com
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s.ramezanislp@gmail.com
between 1 to 2 month after request
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between 1 to 2 month after request
بین یک تا دو ماه بعد از درخواست
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بین یک تا دو ماه بعد از درخواست
I have no comment
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I have no comment
پیشنهادی ندارم
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پیشنهادی ندارم
Protocol summary
Study aim
The therapeutic effect of tDCS combined with routine physiotherapy on the neurological and upper limb motor function in ischemic stroke patients with hemiplegia.
Design
In a randomized double-blind clinical trial, randomized with sealed envelope software, on 52 patients of ischemic stroke with hemiplegia, every group includes 26 individuals.
Settings and conduct
patients with hemiplegia who refer to physiotherapy department,are randomized in two groups of intervention(real transcranial stimulation plus physiotherapy) and control (Sham transcranial stimulation plus physiotherapy). Someone other than the patient and examiner adjusts the device to apply or not electrical stimulation, so the examiner and patient are unaware of the assignment of individuals in the sham and real tDCS groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
age:18-65 years, unilateral ischemic stroke in middle cerebral artery, paralyzed upper limb, time post-stroke from 2 weeks to 1 month, NIHSS than 20
Exclusion criteria:
taking CNS-effective drugs except for TPA and medications used for stroke routine treatment. A history of prior stroke and other non-stroke neurological diseases, clinical instability, no compatibility with safety guidelines of tDCS
Intervention groups
'' intervention group'': real transcranial current stimulation plus routine physiotherapy,
''control group'' : Sham transcranial stimulation plus routine physiotherapy
Main outcome variables
motor function of upper limb based on MRC, stroke deficit severity based on NIHSS score
General information
Reason for update
Reporting the study progression and dates update
Acronym
IRCT registration information
IRCT registration number:IRCT20130416013027N3
Registration date:2020-07-11, 1399/04/21
Registration timing:prospective
Last update:2024-03-07, 1402/12/17
Update count:1
Registration date
2020-07-11, 1399/04/21
Registrant information
Name
Sara Ramezani Kapourchali
Name of organization / entity
Guilan Road Trauma Research Centre
Country
Iran (Islamic Republic of)
Phone
+98 13 1323 8373
Email address
s.ramezanislp@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-01, 1399/10/12
Expected recruitment end date
2021-06-01, 1400/03/11
Actual recruitment start date
2021-12-21, 1400/09/30
Actual recruitment end date
2022-06-25, 1401/04/04
Trial completion date
2022-09-25, 1401/07/03
Scientific title
The effect of bihemispheric transcranial direct current stimulation combined with routine physiotherapy on the motor function of upper limb in the ischemic stroke patients with hemiplegia
Public title
The effect of transcranial direct current stimulation on stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18 and 65 years
unilateral ischemic stroke in middle cerebral artery
upper limb plegia
stroke onset and intervention starting interval from 2 weeks to 1 month
National institude of health stroke scale (NIHSS) score less than 20 at the time of intervention
Exclusion criteria:
cognitive state score in mini mental score examination less than 24
Conditions which are not compatible to safety guidelines of brain stimulation
those with tDCS contraindication , such as pregnant patients, patients with metal implants , those having a heart pacemaker
drug history of psychoactive drugs or CNS effective drugs except tPA and medications used for stroke routine treatment .
substance abusers
Concurrent psychiatric and other non-stroke neurological disease
The use of medications blocking voltage-dependent calcium and sodium channels
History or existence of scalp eczema
Clinical instability
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
52
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization is performed using sealed envelope software. The samples are assigned to 8 randomized blocks including two groups. Therapist randomly selects one block and based on it, the subject is assigned.
Blinding (investigator's opinion)
Double blinded
Blinding description
During blinding, someone other than the patient and examiner adjusts the device to apply or not electrical stimulation, so the examiner and patient are unaware of the assignment of individuals in the sham and real tDCS groups, and only the person adjusting the device, is aware of this.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Guilan University of Medical Sciences
Street address
in front of 17 Shahrivar Hospital – Shahid Siadati Ave. – Namjoo St. – Rasht- Iran
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2019-08-03, 1398/05/12
Ethics committee reference number
IR.GUMS.REC.1398.247
Health conditions studied
1
Description of health condition studied
patients with unilateral ischemic stroke having a paralyzed upper limb
ICD-10 code
I63.9
ICD-10 code description
Cerebrovascular accident-ischemic
Primary outcomes
1
Description
motor function of upper limb
Timepoint
baseline/before intervention, the final session of intervention, three months after final therapy
Method of measurement
Medical Research Council Scale for Muscle Strength (MRC)
Secondary outcomes
1
Description
neurological deficit severity
Timepoint
baseline and final session of intervention, three months after final therapy
Method of measurement
National institute of health stroke scale (NIHSS)
Intervention groups
1
Description
intervention group: 1.5 mA Anodal transcranial electrical stimulation on primary motor cortex of lesion hemisphere and Cathodal stimulation on anologous area of opposite hemisphere. time of stimulation is 30 minutes stimulation in 10 sessions,successive 5 sessions weekly for two weeks . stimulation device manufactured by Mindalive company from Canada.
Category
Rehabilitation
2
Description
control group : Sham transcranial direct current stimulation with1 mA intensity for 3 seconds, 30 minutes physiotherapy each session for 10 sessions, 5 successive sessions per week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina hospital
Full name of responsible person
Sara Ramezani
Street address
Neuroscience research center,Poursina hospital,Namjoo avenue
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 911 833 2694
Fax
Email
s.ramezanislp@gmail.com
Web page address
http://www.gums.ac.ir/gnsrc
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Mohammad Taghi Ashoobi
Street address
Vice President of Management and Resources Development- Parastar Ave – Rasht- Iran
City
Rasht
Province
Guilan
Postal code
6694941446
Phone
+98 13 3333 8373
Fax
+98 13 3333 5821
Email
ashoobi@gums.ac.ir
Web page address
http://www.gums.ac.ir/research
Grant name
Deputy of research and technology at Guilan University of Medical Sciences
Grant code / Reference number
98042925
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Babak Bakhshayesh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
neuroscience research center,Poursina Hospital,Namjou Ave
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3333 8773
Fax
Email
babak.bakh@gmail.com
Web page address
http://www.gums.ac.ir/gnsrc
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sara Ramezani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Neuroscience research center, Poursina hospital, Namjou avenue
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8773
Fax
+98 13 3331 1472
Email
s.ramezanislp@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sara Ramezani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
neuroscience research center, Poursina hospital, Namjou avenue
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8773
Fax
+98 13 3331 1472
Email
s.ramezanislp@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available