Effect of occupation-based modified constraint-induced movement therapy on participation children with cerebral palsy: A double-blind randomized controlled trial
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Protocol summary
Clinical trial with intervention and control group, single blind, and randomized by a table of random numbers.
Clinical trial with intervention and control group, single blind, and randomized by stratified randomization .
Clinical trial with intervention and control group, single blind, and randomized by a table of random numbersstratified randomization .
کارآزمایی بالینی دارای گروه مداخله و کنترل، یک سویه کور، و تصادفی سازی شده توسط جدول اعداد تصادفی.
کارآزمایی بالینی دارای گروه مداخله و کنترل، دو سویه کور، و تصادفی سازی شده به روش تصادفی سازی طبقه ای.
کارآزمایی بالینی دارای گروه مداخله و کنترل، یکدو سویه کور، و تصادفی سازی شده توسط جدول اعدادبه روش تصادفی سازی طبقه ای.
interventions are performed by parents at home based on the treatment plan and training that provided by the therapist. This study is a single blind, and the assessor will be blind at all stages of the study.
interventions are performed by parents at home based on the treatment plan and training that provided by the therapist. This study is a double blind, and the assessor and participants will be blind at all stages of the study.
interventions are performed by parents at home based on the treatment plan and training that provided by the therapist. This study is a singledouble blind, and the assessor and participants will be blind at all stages of the study.
مداخلات در منزل توسط والدین بر اساس برنامه درمانی و آموزش هایی که درمانگر به آن ها می دهد، انجام می شود. این مطالعه یک سویه کور است و ارزیاب در تمامی مراحل این مطالعه کور خواهد بود.
مداخلات در منزل توسط والدین بر اساس برنامه درمانی و آموزش هایی که درمانگر به آن ها می دهد، انجام می شود. این مطالعه دو سویه کور است و ارزیاب و مشارکت کنندگان در تمامی مراحل این مطالعه کور خواهد بود.
مداخلات در منزل توسط والدین بر اساس برنامه درمانی و آموزش هایی که درمانگر به آن ها می دهد، انجام می شود. این مطالعه یکدو سویه کور است و ارزیاب و مشارکت کنندگان در تمامی مراحل این مطالعه کور خواهد بود.
General information
Single blinded
Double blinded
singldoubl
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Based on the reviews done during the study, it was decided to shorten the title. Also, during the sampling, the parents agreed not to be aware of the allocation in the groups in order to make the study result more valuable. For this reason, the double-blind was added in title and its type was changed in the blinding field. Also, the start and end dates of sampling were updated. goal attainment scaling was added to primary measures.
Based on the reviews done during the study, it was decided to shorten the title. Also, during the sampling, the parents agreed not to be aware of the allocation in the groups in order to make the study result more valuable. For this reason, the double-blind was added in title and its type was changed in the blinding field. Also, the start and end dates of sampling were updated. goal attainment scaling was added to primary measures.
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به دلیل بررسی های صورت گرفته در حین مطالعه تصمیم بر آن شد که عنوان کوتاه تر شود. همچنین در حین نمونه گیری والدین موافقت کردند جهت ارزشمندتر شدن نتیجه مطالعه، که از اختصاص در گروه ها آگاهی نداشته باشند. از این جهت عنوان دوسویه کور به عنوان اضافه شد و در فیلد کورسازی، نوع آن تغییر داده شد. مقیاس رسیدن به هدف نیز به ابزارهای اولیه اضافه شد.
به دلیل بررسی های صورت گرفته در حین مطالعه تصمیم بر آن شد که عنوان کوتاه تر شود. همچنین در حین نمونه گیری والدین موافقت کردند جهت ارزشمندتر شدن نتیجه مطالعه، که از اختصاص در گروه ها آگاهی نداشته باشند. از این جهت عنوان دوسویه کور به عنوان اضافه شد و در فیلد کورسازی، نوع آن تغییر داده شد. مقیاس رسیدن به هدف نیز به ابزارهای اولیه اضافه شد.
The effect of m-CIMT based on activity analysised on participation in ADL of spastic hemiplegic children with 5 to 12 years old
Effect of occupation-based modified constraint-induced movement therapy on participation children with cerebral palsy: A double-blind randomized controlled trial
The effectEffect of moccupation-CIMT based on activity analysisedmodified constraint-induced movement therapy on participation in ADL of spastic hemiplegic children with 5 to 12 years oldcerebral palsy: A double-blind randomized controlled trial
تأثیر مداخله حرکت درمانی همراه با محدودیتِ مبتنی بر آنالیز فعالیت بر مشارکت در فعالیتهای روزمره زندگی کودکان همیپلژی اسپاستیک 5 الی 12 ساله
تأثیر مداخله حرکت درمانی همراه با محدودیتِ مبتنی بر آکیوپیشن بر مشارکت در کودکان مبتلا به فلج مغزی: یک مطالعه دو سویه کور
تأثیر مداخله حرکت درمانی همراه با محدودیتِ مبتنی بر آنالیز فعالیتآکیوپیشن بر مشارکت در فعالیتهای روزمره زندگی کودکان همیپلژی اسپاستیک 5 الی 12 سالهمبتلا به فلج مغزی: یک مطالعه دو سویه کور
Randomization in the form of simple randomization based on participants' gender, age, and level of MACS will be performed by SPSS software after pre-assessments and informed consent of parents prior to the start of the intervention. Only the first author will be informed of the allocation of participants in the groups, and the assessor will not be informed of the allocation of participants in the groups.
A stratified randomization is performed to assign children to groups. Two categories, MACS level I and II and MACS level III, are included in the table of random numbers. Plaques are enclosed in matte numbered sealed envelopes that are stored by the therapist.
RandomizationA stratified randomization is performed to assign children to groups. Two categories, MACS level I and II and MACS level III, are included in the formtable of simple randomization based on participants' gender, age, and level of MACS will be performedrandom numbers. Plaques are enclosed in matte numbered sealed envelopes that are stored by SPSS software after pre-assessments and informed consent of parents prior to the start of the interventiontherapist. Only the first author will be informed of the allocation of participants in the groups, and the assessor will not be informed of the allocation of participants in the groups.
تصادفی سازی ساده بر اساس جنسیت، سن و سطح MACS شرکت کنندگان پس از ارزیابی های اولیه و کسب رضایت آگاهانه از والدین توسط نرم افزار SPSS، قبل از شروع مداخله تهیه انجام خواهد شد. فقط محقق اصلی از اختصاص شرکت کنندگان در گروه ها اصلاع خواهد داشت و ارزیاب از اختصاص شرکت کنندگان در گروه ها اطلاع نخواهد داشت.
تصادفی طبقه ای برای اختصاص کودکان به گروه ها انجام می شود. دو دسته ، یعنی سطح MACS I و II و سطح MACS III در جدول اعداد تصادفی گنجانده می شوند. پلاک ها در پاکت های مهر و موم شده شماره دار مات محصور می شوند که توسط درمانگر نگهداری می شوند.
تصادفی سازی ساده بر اساس جنسیتطبقه ای برای اختصاص کودکان به گروه ها انجام می شود. دو دسته ، سنیعنی سطح MACS I و II و سطح MACS شرکت کنندگان پس از ارزیابیIII در جدول اعداد تصادفی گنجانده می شوند. پلاک ها در پاکت های اولیهمهر و کسب رضایت آگاهانه از والدینموم شده شماره دار مات محصور می شوند که توسط نرم افزار SPSS، قبل از شروع مداخله تهیه انجام خواهد شددرمانگر نگهداری می شوند. فقط محقق اصلی از اختصاص شرکت کنندگان در گروه ها اصلاع خواهد داشت و ارزیاب از اختصاص شرکت کنندگان در گروه ها اطلاع نخواهد داشت.
In this study, the assessor will be blind at all stages, the assessment before the intervention, the assessment after the intervention, and the assessment at the time of follow-up, and the assessor will not know which group each child is in.
In this study, the assessor will be blind at all stages, the assessment before the intervention, the assessment after the intervention, and the assessment at the time of follow-up, and the assessor will not know which group each child is in. Also, parents and clients will not be informed about the assignment in the groups.
In this study, the assessor will be blind at all stages, the assessment before the intervention, the assessment after the intervention, and the assessment at the time of follow-up, and the assessor will not know which group each child is in. Also, parents and clients will not be informed about the assignment in the groups.
در این مطالعه ارزیاب در تمام مراحل، ارزیابی قبل از شروع مداخله، ارزیابی بعد از اتمام مداخله و ارزیابی در زمان پیگیری، کور خواهد بود. بدین صورت که ارزیابی در هیچ کدام از مراحل ارزیابی از اینکه هر نمونه در کدام گروه قرار دارد، اطلاع نخواهد داشت.
در این مطالعه ارزیاب در تمام مراحل، ارزیابی قبل از شروع مداخله، ارزیابی بعد از اتمام مداخله و ارزیابی در زمان پیگیری، کور خواهد بود. بدین صورت که ارزیابی در هیچ کدام از مراحل ارزیابی از اینکه هر نمونه در کدام گروه قرار دارد، اطلاع نخواهد داشت. همچنین والدین و مراجعین از اختصاص در گروه ها اطلاع نخواهند داشت.
در این مطالعه ارزیاب در تمام مراحل، ارزیابی قبل از شروع مداخله، ارزیابی بعد از اتمام مداخله و ارزیابی در زمان پیگیری، کور خواهد بود. بدین صورت که ارزیابی در هیچ کدام از مراحل ارزیابی از اینکه هر نمونه در کدام گروه قرار دارد، اطلاع نخواهد داشت. همچنین والدین و مراجعین از اختصاص در گروه ها اطلاع نخواهند داشت.
Primary outcomes
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Score obtained from the amount of goal achievement by the goal attainment scaling tool
Score obtained from the amount of goal achievement by the goal attainment scaling tool
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نمره کسب شده از میزان دست یابی به هدف توسط ابزار مقیاس رسیدن به هدف
نمره کسب شده از میزان دست یابی به هدف توسط ابزار مقیاس رسیدن به هدف
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Measure participation at the beginning of the study (before the intervention), 1 and 3 months after the start of the intervention.
Measure participation at the beginning of the study (before the intervention), 1 and 3 months after the start of the intervention.
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اندازه گیری مشارکت در ابتدای مطالعه (قبل از شروع مداخله) و 1، 3 ماه پس از شروع مداخلات.
اندازه گیری مشارکت در ابتدای مطالعه (قبل از شروع مداخله) و 1، 3 ماه پس از شروع مداخلات.
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goal attainment scaling
goal attainment scaling
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مقیاس رسیدن به هدف
مقیاس رسیدن به هدف
Recruitment centers
#1
Name of recruitment center - English: occupational therapy clinic of school rehabilitation of Iran University of Medical Sciences and othe
Name of recruitment center - Persian: کلینیک کاردرمانی دانشکده توانبخشی دانشگاه علوم پزشکی ایران و سایر کلینیک های توانبخشی
Full name of responsible person - English: Malek amini
Full name of responsible person - Persian: مالک امینی
Street address - English: Tehran, Mirdamad, Madar Square, Shah Nazari St., Madadkaran St., school of Rehabilitation Sciences, Iran University of Medical Sciences
Street address - Persian: تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1545913487
Phone: +98 21 2222 7124
Fax:
Email: rehab@iums.ac.ir
Web page address:
Name of recruitment center - English: occupational therapy clinic of school rehabilitation of Iran University of Medical Sciences and othe
Name of recruitment center - Persian: کلینیک کاردرمانی دانشکده توانبخشی دانشگاه علوم پزشکی ایران و سایر کلینیک های توانبخشی
Full name of responsible person - English: Malek amini
Full name of responsible person - Persian: مالک امینی
Street address - English: Madadkaran St., Shah Nazari St., Madar Square, Mirdamad Blvd, Tehran
Street address - Persian: تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1545913487
Phone: +98 21 2222 7124
Fax:
Email: rehab@iums.ac.ir
Web page address:
Name of recruitment center - English: occupational therapy clinic of school rehabilitation of Iran University of Medical Sciences and othe Name of recruitment center - Persian: کلینیک کاردرمانی دانشکده توانبخشی دانشگاه علوم پزشکی ایران و سایر کلینیک های توانبخشی Full name of responsible person - English: Malek amini Full name of responsible person - Persian: مالک امینی Street address - English: Tehran, Mirdamad, Madar SquareMadadkaran St., Shah Nazari St., Madadkaran St.Madar Square, school of Rehabilitation SciencesMirdamad Blvd, Iran University of Medical SciencesTehran Street address - Persian: تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1545913487 Phone: +98 21 2222 7124 Fax: Email: rehab@iums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Abbas motevalian
Full name of responsible person - Persian: عباس متولیان
Street address - English: Tehran, Hemmat Highway, next to Milad Tower, Iran University of Medical Sciences, fifth floor of the Central Headquarters
Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران، طبقه پنجم ستاد مرکزی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8670 2503
Fax:
Email: research-m@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Abbas Motevalian
Full name of responsible person - Persian: عباس متولیان
Street address - English: Next to Milad Tower, Hemmat Highway, Tehran
Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران، طبقه پنجم ستاد مرکزی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8670 2503
Fax:
Email: research-m@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Abbas motevalianMotevalian Full name of responsible person - Persian: عباس متولیان Street address - English: Tehran, Hemmat Highway, nextNext to Milad Tower, Iran University of Medical SciencesHemmat Highway, fifth floor of the Central HeadquartersTehran Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران، طبقه پنجم ستاد مرکزی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1449614535 Phone: +98 21 8670 2503 Fax: Email: research-m@iums.ac.ir Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Malek Amini
Full name of responsible person - Persian: مالک امینی
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 72
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Madadkaran St., Shah Nazari St., Madar Square, Mirdamad Blvd, Tehran
Street address - Persian: تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1545913487
Phone: 0098 21 222228051
Mobile: +98 912 952 4533
Fax:
Email: malekamini8@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Malek Amini
Full name of responsible person - Persian: مالک امینی
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 72
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Madadkaran St., Shah Nazari St., Madar Square, Mirdamad Blvd, Tehran
Street address - Persian: تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1545913487
Phone: 0098 21 222228051
Mobile: +98 912 952 4533
Fax:
Email: malekamini8@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Malek Amini Full name of responsible person - Persian: مالک امینی Position - English: AssistantAssociate professor Position - Persian: استادیاردانشیار Latest degree: phd Area of specialty/work: 72 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Madadkaran St., Shah Nazari St., Madar Square, Mirdamad Blvd, Tehran Street address - Persian: تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1545913487 Phone: 0098 21 222228051 Mobile: +98 912 952 4533 Fax: Email: malekamini8@gmail.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Malek Amini
Full name of responsible person - Persian: مالک امینی
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 72
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Madadkaran St., Shah Nazari St., Madar Square, Mirdamad Blvd, Tehran
Street address - Persian: تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1545913487
Phone: 0098 21 222228051
Mobile: +98 912 542 4533
Fax:
Email: malekamini8@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Malek Amini
Full name of responsible person - Persian: مالک امینی
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 72
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Madadkaran St., Shah Nazari St., Madar Square, Mirdamad Blvd, Tehran
Street address - Persian: تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1545913487
Phone: 0098 21 222228051
Mobile: +98 912 542 4533
Fax:
Email: malekamini8@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Malek Amini Full name of responsible person - Persian: مالک امینی Position - English: AssistantAssociate professor Position - Persian: استادیاردانشیار Latest degree: phd Area of specialty/work: 72 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Madadkaran St., Shah Nazari St., Madar Square, Mirdamad Blvd, Tehran Street address - Persian: تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1545913487 Phone: 0098 21 222228051 Mobile: +98 912 542 4533 Fax: Email: malekamini8@gmail.com Web page address:
Protocol summary
Study aim
The aim of this study was to investigate the effect of constraint induced movement therapy using with activity analysis strategy on participation of children with hemiplegia and emphasis on generalizing skills that learned in activities of daily living; the treatment of each child is based on the client centered paradigm in occupational therapy and is special for each child and the goals of the treatment will be based on what child and their parent wants.
Design
Clinical trial with intervention and control group, single blind, and randomized by stratified randomization .
Settings and conduct
interventions are performed by parents at home based on the treatment plan and training that provided by the therapist. This study is a double blind, and the assessor and participants will be blind at all stages of the study.
Participants/Inclusion and exclusion criteria
Children between the ages of 5 and 12 who have been diagnosed with hemiplegia and have good balance and no history of seizure or have controlled seizures, and do not intend to inject Botox or surgery during the intervention. They also have the ability to tolerate the restriction of less affected upper extremity.
Intervention groups
In the intervention group, the m-CIMT technique will be performed by using the activity analysis strategy and will be done based on the goals that child and their parent wants, and in the control group, the m-CIMT technique will be performed routinely and will be done based on the goals that child and their parent wants.
Main outcome variables
participation; manual ability
General information
Reason for update
Based on the reviews done during the study, it was decided to shorten the title. Also, during the sampling, the parents agreed not to be aware of the allocation in the groups in order to make the study result more valuable. For this reason, the double-blind was added in title and its type was changed in the blinding field. Also, the start and end dates of sampling were updated. goal attainment scaling was added to primary measures.
Acronym
IRCT registration information
IRCT registration number:IRCT20191109045376N1
Registration date:2020-07-16, 1399/04/26
Registration timing:prospective
Last update:2021-05-09, 1400/02/19
Update count:1
Registration date
2020-07-16, 1399/04/26
Registrant information
Name
Ali Ostadzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4407 2090
Email address
ostadzadeh.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of occupation-based modified constraint-induced movement therapy on participation children with cerebral palsy: A double-blind randomized controlled trial
Public title
Investigating the effect of using activity analysis strategy when using m-CIMT
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
The child has been diagnosed by a neurologist with cerebral palsy
The child has levels I, II and III of the MACS scale
The child can actively extend the wrist of the affected limb by 20 degrees
The child can actively extend the fingers of the affected limb by 10 degrees
The child achieve score above 44 in PBS test
The child does not have vision problems
The child does not have a behavioral problem that can withstand the restriction
The child's IQ is above 70
The child has not received upper limb surgery and Botox injections in the past 6 months and does not intend to do so during the interventions
Exclusion criteria:
Lack of desire of family or child to continue interventions
Age
From 5 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
A stratified randomization is performed to assign children to groups. Two categories, MACS level I and II and MACS level III, are included in the table of random numbers. Plaques are enclosed in matte numbered sealed envelopes that are stored by the therapist.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the assessor will be blind at all stages, the assessment before the intervention, the assessment after the intervention, and the assessment at the time of follow-up, and the assessor will not know which group each child is in. Also, parents and clients will not be informed about the assignment in the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of IranUniversity of Medical Sciences
Street address
No. 39, Unit 5, Asadi Alley, between Jeyhun and Zanjan, Toos St.
City
Tehran
Province
Tehran
Postal code
1343977753
Approval date
2020-04-15, 1399/01/27
Ethics committee reference number
IR.IUMS.REC.1399.299
Health conditions studied
1
Description of health condition studied
cerebral palsy
ICD-10 code
G80.2
ICD-10 code description
Spastic hemiplegic cerebral palsy
Primary outcomes
1
Description
The score obtained is related to the two categories of satisfaction and performance in the canadian occupational performance measure questionnaire
Timepoint
Measure participation at the beginning of the study (before the intervention), 1 and 3 months after the start of the intervention.
Method of measurement
Canadian occupational performance measure questionnaire
2
Description
Score obtained from the amount of goal achievement by the goal attainment scaling tool
Timepoint
Measure participation at the beginning of the study (before the intervention), 1 and 3 months after the start of the intervention.
Method of measurement
goal attainment scaling
Secondary outcomes
1
Description
Score obtained in the ABILHAND-Kids questionnaire
Timepoint
Measure manual ability at the beginning of the study (before the intervention), 1 and 3 months after the intervention.
Method of measurement
ABILHAND-Kids questionnaire
2
Description
Score obtained in the pediatric motor activity log questionnaire
Timepoint
Measure manual ability at the beginning of the study (before the intervention), 1 and 3 months after the intervention.
Method of measurement
pediatric motor activity log questionnaire
Intervention groups
1
Description
Intervention group: Based on the set goals, the child will be analyzed on the basis of OTPF motor skills items. Then, based on the child's defects based on OTPF activity analysis items, according to the interests of each child, a treatment plan in the form of play and activities of daily living is designed and graded based on the principles of motor learning by the therapist and given to parents to practice with the child. Parents will also be given the necessary training (the nature and manner of doing exercises such as shaping, hardening, and repetition) to perform interventions at home. Participants in this group will be treated at home for 4 weeks, 3 days a week and 1 hour a day by the parents according to the program prepared by the therapist, during this time the less affected upper extrimity will be restricted by the strap. Also, a less affected upper extrimity will be restricted to 5 to 6 hours apart from interventions during activities of daily living. At the end of each session, the therapist will call with each parents and asked about the time limit and activities during intervention restriction time and other restriction time and activities are done by child in non-restricted time, and based on the purpose of the study (performing M-CIMT interventions based on activity analysis), parents will be given the necessary feedback.
Category
Rehabilitation
2
Description
Control group: According to the child's interests, the treatment plan in the form of play and activities of daily living is designed and graded (being more difficult) based on principles of motor learning by the therapist and given to the parents to practice with the child at home. Parents will also be given the necessary training (the nature and manner of doing exercises such as shaping, hardening, and repetition) to perform interventions at home. Participants in this group will receive routine m-CIMT interventions (without activity analysis and no emphasis on defects in OTPF activity analysis items when performing this technique); The duration of the interventions will be the same as the intervention group for 4 weeks, 3 days a week and 1 hour per day. Also, less affected upper extremity will be restricted 5 to 6 hours apart from interventions during daily life activities. At the end of each session, the therapist will call with each parents and asked about the time limit and activities during intervention restriction time and other restriction time and activities are done by child in non-restricted time, and based on the purpose of the study (performing routine m-CIMT interventions without activity analysis), parents will be given the necessary feedback.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
occupational therapy clinic of school rehabilitation of Iran University of Medical Sciences and othe
Full name of responsible person
Malek amini
Street address
Madadkaran St., Shah Nazari St., Madar Square, Mirdamad Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
rehab@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motevalian
Street address
Next to Milad Tower, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Malek Amini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Madadkaran St., Shah Nazari St., Madar Square, Mirdamad Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
0098 21 222228051
Email
malekamini8@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Malek Amini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Madadkaran St., Shah Nazari St., Madar Square, Mirdamad Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
0098 21 222228051
Email
malekamini8@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Ostadzadeh
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 39, Unit 5, Asadi Alley, Between Jeyhun and Zanjan, Toos St.
City
Tehran
Province
Tehran
Postal code
1343977753
Phone
+98 21 6604 8100
Email
aliostadzadeh4@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