Effect of Computerized Visual Games on Handwriting, Visual Perception and Visual Motor Integration in the Children with Spastic Cerebral Palsy in the second and third grades of elementary schools.
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Protocol summary
A clinical trial with a control group, parallel groups, one-strain blind, randomized, on 30 children. A www.sealedenvelope.com site will be used for randomization.
A clinical trial with a control group, parallel groups, one-strain blind, randomized, on 30 children. A stratified permuted block randomization method will be used.
A clinical trial with a control group, parallel groups, one-strain blind, randomized, on 30 children. A www.sealedenvelope.com sitestratified permuted block randomization method will be used for randomization.
کارآزمایی بالینی دارای گروه کنترل، باگروه های موازی، یک سویه کور، تصادفی شده، بر روی 30 کودک . برای تصادفی سازی از سایت www.sealedenvelope.com استفاده خواهد شد.
کارآزمایی بالینی دارای گروه کنترل، باگروه های موازی، یک سویه کور، تصادفی شده، بر روی 30 کودک . از روش تصادفیسازی بلوکهای متناوب طبقهبندیشده استفاده خواهد شد.
کارآزمایی بالینی دارای گروه کنترل، باگروه های موازی، یک سویه کور، تصادفی شده، بر روی 30 کودک . برایاز روش تصادفیسازی از سایت www.sealedenvelope.comبلوکهای متناوب طبقهبندیشده استفاده خواهد شد.
one of the intervention groups will receive visual perception game. The other intervention group will receive visual-motor integration play, and the third group, as the control group, will not receive any of these games.
One of the intervention groups will receive the visual perception game alongside traditional handwriting exercises. The other intervention group will receive the visual-motor integration game in addition to traditional handwriting exercises, while the third group, serving as the control group, will not receive any of these games and will only perform traditional handwriting exercises.
oneOne of the intervention groups will receive the visual perception game alongside traditional handwriting exercises. The other intervention group will receive the visual-motor integration playgame in addition to traditional handwriting exercises, andwhile the third group, serving as the control group, will not receive any of these games and will only perform traditional handwriting exercises.
یکی از گروه های مداخله ای، بازی ادراک بینایی را دریافت خواهد کرد. گروه مداخله ی دیگر، بازی یکپارچگی بینایی_حرکتی را دریافت خواهد کرد و گروه سوم به عنوان گروه کنترل، هیچ کدام از این بازی ها را دریافت نخواهد کرد.
یکی از گروه های مداخله ای، بازی ادراک بینایی را در کنار تمارین مرسوم دست نویسی دریافت خواهد کرد. گروه مداخله ی دیگر، بازی یکپارچگی بینایی_حرکتی را در کنار تمارین مرسوم دست نویسی دریافت خواهد کرد و گروه سوم به عنوان گروه کنترل، هیچ کدام از این بازی ها را دریافت نخواهد کرد (فقط تمارین مرسوم دست نویسی را خواهند داشت).
یکی از گروه های مداخله ای، بازی ادراک بینایی را در کنار تمارین مرسوم دست نویسی دریافت خواهد کرد. گروه مداخله ی دیگر، بازی یکپارچگی بینایی_حرکتی را در کنار تمارین مرسوم دست نویسی دریافت خواهد کرد و گروه سوم به عنوان گروه کنترل، هیچ کدام از این بازی ها را دریافت نخواهد کرد (فقط تمارین مرسوم دست نویسی را خواهند داشت).
General information
2023-05-07, 1402/02/17
2025-09-23, 1404/07/01
20232025-0509-0723 00:00:00
2023-08-21, 1402/05/30
2026-09-23, 1405/07/01
20232026-0809-2123 00:00:00
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Update of randomization method, recruitment status, and further clarification of interventions to ensure consistency with the final study protocol and in response to journal requirements.
Update of randomization method, recruitment status, and further clarification of interventions to ensure consistency with the final study protocol and in response to journal requirements.
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اصلاح روش تصادفیسازی، بهروزرسانی وضعیت مطالعه و شفافسازی بیشتر مداخلات، برای هماهنگی با نسخه نهایی پروتکل و رفع نظرات ژورنال.
اصلاح روش تصادفیسازی، بهروزرسانی وضعیت مطالعه و شفافسازی بیشتر مداخلات، برای هماهنگی با نسخه نهایی پروتکل و رفع نظرات ژورنال.
Children with modified visual acuity with glasses less than 0.7 in close vision
Children with obvious eye deviation (strabismus)
Children with any kind of orthopedic anomalies, upper extremity surgeries in the last six months or botulinum injections in the last three months
Children with modified visual acuity with glasses less than 0.8 in close vision
Children with obvious eye deviation (strabismus)
Children with any kind of orthopedic anomalies, upper extremity surgeries in the last six months or botulinum injections in the last three months
Children with modified visual acuity with glasses less than 0.70.8 in close vision Children with obvious eye deviation (strabismus) Children with any kind of orthopedic anomalies, upper extremity surgeries in the last six months or botulinum injections in the last three months
- کودکانی که حدت بینایی اصلاح شده با عینک کمتر از 0/7 دید نزدیک دارند
کودکانی که انحراف چشم آشکار (استرابیسم) دارند
کودکانی که دارای هرنوع آنومالی های ارتوپدی، انجام جراحی ها در اندام فوقانی در شش ماه اخیر و یا تزریق بوتولونیوم در سه ماه اخیر باشند
- کودکانی که حدت بینایی اصلاح شده با عینک کمتر از 0/8 دید نزدیک دارند
کودکانی که انحراف چشم آشکار (استرابیسم) دارند
کودکانی که دارای هرنوع آنومالی های ارتوپدی، انجام جراحی ها در اندام فوقانی در شش ماه اخیر و یا تزریق بوتولونیوم در سه ماه اخیر باشند
- کودکانی که حدت بینایی اصلاح شده با عینک کمتر از 0/78 دید نزدیک دارند کودکانی که انحراف چشم آشکار (استرابیسم) دارند کودکانی که دارای هرنوع آنومالی های ارتوپدی، انجام جراحی ها در اندام فوقانی در شش ماه اخیر و یا تزریق بوتولونیوم در سه ماه اخیر باشند
In this study, restricted randomization method and random allocation method will be used. Children will be divided into three groups after meeting the inclusion criteria by random allocation law.
For randomization, the method of sealed envelopes will be used. After determining the sample size (30 people), 10 envelopes will be allocated to group a, and 10 envelopes will be allocated to group b ,and 10 envelopes will be allocated to group c.
Then these envelopes are moved completely to ensure that they are not in order. Then it will be placed in a container and based on the list of study participants, an envelope will be assigned to each of them, and finally it will be determined which group each participant belongs to.
A stratified permuted block randomization method will be used in this trial. Participants will first be stratified based on the type of spastic cerebral palsy into three strata: hemiplegia, diplegia, and quadriplegia. Within each stratum, participants will be randomly assigned to one of the three study groups: Group A (visual-motor integration intervention), Group B (visual perception intervention), and Group C (control group). Thus, randomization will be performed separately within each CP subtype to ensure balance across groups. To achieve allocation concealment, we will use sealed, opaque envelopes made with foil and carbon paper to prevent any visibility of group assignment. Since we are not certain about the exact number of participants in each CP subtype in advance, and to follow recommendations from similar studies (e.g., Doig et al., 2005), we will prepare more than the planned 30 envelopes specifically, 81 envelopes in total, consisting of 27 for each group (A, B, and C). These envelopes will be distributed across three Tupperware-style containers, each labeled according to the CP subtype (hemiplegia, diplegia, quadriplegia). In each container, 9 envelopes from each group (A, B, and C) will be placed (totaling 27 envelopes per stratum). These envelopes will not be mixed between strata. Within each stratum, random blocks of size 3 and 6 will be created, and envelopes will be shuffled within each block. To determine the sequence of blocks, a coin-flipping method will be used: if the coin lands on heads, a block of size 3 will be selected; if tails, a block of size 6. This process will be repeated until a complete block sequence is generated for each stratum. Once the block order is finalized, it will remain fixed. Subsequently, envelopes within each stratum will be numbered sequentially: H1–H27 for hemiplegia, D1–D27 for diplegia, and Q1–Q27 for quadriplegia. As each participant enters the trial, after being classified by CP subtype, the next available envelope in that stratum will be assigned to them in sequence. Importantly, this entire randomization and allocation process will be performed by an independent researcher who is not involved in recruitment, intervention delivery, or outcome assessments, in order to minimize potential bias 54.
In this study, restrictedA stratified permuted block randomization method and random allocation method will be used in this trial. ChildrenParticipants will first be stratified based on the type of spastic cerebral palsy into three strata: hemiplegia, diplegia, and quadriplegia. Within each stratum, participants will be divided intorandomly assigned to one of the three study groups after meeting: Group A (visual-motor integration intervention), Group B (visual perception intervention), and Group C (control group). Thus, randomization will be performed separately within each CP subtype to ensure balance across groups. To achieve allocation concealment, we will use sealed, opaque envelopes made with foil and carbon paper to prevent any visibility of group assignment. Since we are not certain about the inclusion criteria by random allocation lawexact number of participants in each CP subtype in advance, and to follow recommendations from similar studies (e.g. For randomization, Doig et al., 2005), we will prepare more than the methodplanned 30 envelopes specifically, 81 envelopes in total, consisting of sealed27 for each group (A, B, and C). These envelopes will be used. After determiningdistributed across three Tupperware-style containers, each labeled according to the sampleCP subtype (hemiplegia, diplegia, quadriplegia). In each container, 9 envelopes from each group (A, B, and C) will be placed (totaling 27 envelopes per stratum). These envelopes will not be mixed between strata. Within each stratum, random blocks of size (30 people)3 and 6 will be created, 10and envelopes will be allocated to groupshuffled within each block. To determine the sequence of blocks, a, and 10 envelopes coin-flipping method will be allocated to group b used: if the coin lands on heads,and 10 envelopes a block of size 3 will be allocated to group cselected; if tails, a block of size 6. Then these envelopes are moved completely to ensure that they are not inThis process will be repeated until a complete block sequence is generated for each stratum. Once the block order. Then is finalized, it will remain fixed. Subsequently, envelopes within each stratum will be placednumbered sequentially: H1–H27 for hemiplegia, D1–D27 for diplegia, and Q1–Q27 for quadriplegia. As each participant enters the trial, after being classified by CP subtype, the next available envelope in a container and based on the list of study participants, an envelopethat stratum will be assigned to each of them in sequence. Importantly, this entire randomization and finally itallocation process will be determined which group each participant belongsperformed by an independent researcher who is not involved in recruitment, intervention delivery, or outcome assessments, in order to minimize potential bias 54.
در این مطالعه از روش تصادفی سازی محدود و از روش تخصیص تصادفی استفاده خواهد شد. کودکان پس از احراز شرایط ورود به مطالعه به روش قانون تخصیص تصادفی ، در سه گروه تقسیم خواهند شد.
برای تصادفی سازی، از روش پاکت نامه های مهر و موم شده استفاده خواهد شد.به این صورت که پس از مشخص شدن حجم نمونه (30 نفر) 10 پاکت اختصاص یابد به گروه a و 10 پاکت اختصاص یابد به گروه b و 10پاکت اختصاص یابد به گروه c . سپس این پاکت ها کاملا جابجا شوند تا از به ترتیب نبودن آنها اطمینان حاصل شود . سپس درون ظرفی قرار خواهد گرفت و بر اساس لیست ورود شرکت کنندگان به مطالعه، برای هرکدام یک پاکت اختصاص خواهد یافت و در نهایت مشخص خواهد شد که شرکت کنندگان هر کدام به کدام گروه تعلق دارند.
در این کارآزمایی از روش تصادفیسازی بلوکهای متناوب طبقهبندیشده استفاده خواهد شد. ابتدا شرکتکنندگان بر اساس نوع فلج مغزی اسپاستیک به سه طبقه تقسیم میشوند: همیپلژی، دیپلژی و کوادریپلژی. در هر طبقه، شرکتکنندگان بهطور تصادفی به یکی از سه گروه مطالعه تخصیص داده میشوند: گروه A (مداخله یکپارچگی دیداری-حرکتی)، گروه B (مداخله ادراک دیداری) و گروه C (گروه کنترل). بدین ترتیب، تصادفیسازی بهطور جداگانه در هر زیرگروه فلج مغزی انجام میشود تا تعادل میان گروهها برقرار گردد.
برای تحقق اختفای تخصیص، از پاکتهای دربسته، مات و غیرقابلرویت (ساختهشده با فویل و کاغذ کاربن) استفاده میکنیم تا محتوای تخصیص گروهها قابل مشاهده نباشد. با توجه به اینکه تعداد دقیق شرکتکنندگان در هر زیرگروه CP از پیش مشخص نیست و با استناد به توصیههای مطالعات مشابه (برای مثال Doig و همکاران، 2005)، بیش از 30 پاکت برنامهریزیشده آماده خواهد شد؛ در مجموع 81 پاکت، شامل 27 پاکت برای هر گروه (A، B و C). این پاکتها در سه ظرف پلاستیکی مجزا (مانند تاپرور) قرار داده میشوند که هرکدام بر اساس نوع CP (همیپلژی، دیپلژی، کوادریپلژی) برچسبگذاری میشود. در هر ظرف 9 پاکت از هر گروه (A، B و C) قرار داده میشود (در مجموع 27 پاکت برای هر طبقه). پاکتها بین طبقات با هم مخلوط نخواهند شد.
در هر طبقه، بلوکهای تصادفی با اندازههای 3 و 6 ایجاد میشود و پاکتها در داخل هر بلوک بهطور کامل بر زده خواهند شد. برای تعیین ترتیب بلوکها از روش پرتاب سکه استفاده میشود: اگر روی سکه شیر بیاید، بلوک با اندازه 3 انتخاب میشود و اگر خط بیاید، بلوک با اندازه 6 انتخاب خواهد شد. این فرایند تا زمانی که یک توالی کامل از بلوکها برای هر طبقه ساخته شود، ادامه مییابد. پس از نهایی شدن ترتیب بلوکها، این توالی ثابت باقی خواهد ماند.
در ادامه، پاکتها در هر طبقه بهصورت متوالی شمارهگذاری خواهند شد: H1 تا H27 برای همیپلژی، D1 تا D27 برای دیپلژی و Q1 تا Q27 برای کوادریپلژی. به محض ورود هر شرکتکننده به مطالعه، پس از تعیین زیرگروه CP او، اولین پاکت موجود در آن طبقه به ترتیب تخصیص داده خواهد شد. نکته مهم این است که کل فرآیند تصادفیسازی و تخصیص، توسط یک پژوهشگر مستقل که در فرآیند جذب، اجرای مداخله یا ارزیابی پیامدها دخالتی ندارد، انجام خواهد شد تا هرگونه سوگیری احتمالی به حداقل برسد.
در این مطالعهکارآزمایی از روش تصادفیسازی محدود و از روش تخصیص تصادفیبلوکهای متناوب طبقهبندیشده استفاده خواهد شد. کودکان پسابتدا شرکتکنندگان بر اساس نوع فلج مغزی اسپاستیک به سه طبقه تقسیم میشوند: همیپلژی، دیپلژی و کوادریپلژی. در هر طبقه، شرکتکنندگان بهطور تصادفی به یکی از احراز شرایط ورودسه گروه مطالعه تخصیص داده میشوند: گروه A (مداخله یکپارچگی دیداری-حرکتی)، گروه B (مداخله ادراک دیداری) و گروه C (گروه کنترل). بدین ترتیب، تصادفیسازی بهطور جداگانه در هر زیرگروه فلج مغزی انجام میشود تا تعادل میان گروهها برقرار گردد. برای تحقق اختفای تخصیص، از پاکتهای دربسته، مات و غیرقابلرویت (ساختهشده با فویل و کاغذ کاربن) استفاده میکنیم تا محتوای تخصیص گروهها قابل مشاهده نباشد. با توجه به مطالعهاینکه تعداد دقیق شرکتکنندگان در هر زیرگروه CP از پیش مشخص نیست و با استناد به روش قانون تخصیص تصادفی توصیههای مطالعات مشابه (برای مثال Doig و همکاران، 2005)، بیش از 30 پاکت برنامهریزیشده آماده خواهد شد؛ در مجموع 81 پاکت، شامل 27 پاکت برای هر گروه (A، B و C). این پاکتها در سه ظرف پلاستیکی مجزا (مانند تاپرور) قرار داده میشوند که هرکدام بر اساس نوع CP (همیپلژی، دیپلژی، کوادریپلژی) برچسبگذاری میشود. در هر ظرف 9 پاکت از هر گروه تقسیم(A، B و C) قرار داده میشود (در مجموع 27 پاکت برای هر طبقه). پاکتها بین طبقات با هم مخلوط نخواهند شد. در هر طبقه، بلوکهای تصادفی با اندازههای 3 و 6 ایجاد میشود و پاکتها در داخل هر بلوک بهطور کامل بر زده خواهند شد. برای تصادفی سازی،تعیین ترتیب بلوکها از روش پاکت نامه های مهرپرتاب سکه استفاده میشود: اگر روی سکه شیر بیاید، بلوک با اندازه 3 انتخاب میشود و موم شده استفادهاگر خط بیاید، بلوک با اندازه 6 انتخاب خواهد شد.بهشد. این صورتفرایند تا زمانی که یک توالی کامل از بلوکها برای هر طبقه ساخته شود، ادامه مییابد. پس از مشخصنهایی شدن حجم نمونه (30 نفر) 10ترتیب بلوکها، این توالی ثابت باقی خواهد ماند. در ادامه، پاکت اختصاص یابدها در هر طبقه بهصورت متوالی شمارهگذاری خواهند شد: H1 تا H27 برای همیپلژی، D1 تا D27 برای دیپلژی و Q1 تا Q27 برای کوادریپلژی. به گروه a و 10 پاکت اختصاص یابد به گروه b و 10پاکت اختصاص یابد به گروه c . سپس این پاکت ها کاملا جابجا شوند تا از به ترتیب نبودن آنها اطمینان حاصل شود . سپس درون ظرفی قرار خواهد گرفت و بر اساس لیستمحض ورود هر شرکت کنندگانکننده به مطالعه، برای هرکدامپس از تعیین زیرگروه CP او، اولین پاکت موجود در آن طبقه به ترتیب تخصیص داده خواهد شد. نکته مهم این است که کل فرآیند تصادفیسازی و تخصیص، توسط یک پاکت اختصاص خواهد یافت وپژوهشگر مستقل که در نهایت مشخصفرآیند جذب، اجرای مداخله یا ارزیابی پیامدها دخالتی ندارد، انجام خواهد شد که شرکت کنندگان هر کدامتا هرگونه سوگیری احتمالی به کدام گروه تعلق دارندحداقل برسد.
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Aida Kazemnazhand Asl
Full name of responsible person - Persian: آیدا کاظم نژند اصل
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 77
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Girls' Dormitory of Tehran University of Medical Sciences, Noth Kargar Ave, Amir Abad, Teharn city
Street address - Persian: تهران. امیر آباد. خیابان کارگر شمالی. خوابگاه دخترانه ی علوم پزشکی تهران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1439955975
Phone: +98 21 8670 5503
Mobile: +98 914 422 5596
Fax:
Email: a-kazemnazhand@razi.tums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Hamid Dalvand
Full name of responsible person - Persian: دکتر حمید دالوند
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: Tehran, Pich-e Shomiran, School of Rehabilitation, Tehran University of Medical Sciences
Street address - Persian: تهران. پیچ شمیران. دانشکده توانبخشی دانشگاه علوم پزشکی تهران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1439955975
Phone: +98 21 8670 5503
Mobile: +98 912 206 3968
Fax:
Email: hamiddalvand@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Aida Kazemnazhand AslDr. Hamid Dalvand Full name of responsible person - Persian: آیدا کاظم نژند اصلدکتر حمید دالوند Position - English: StudentAssociate professor Position - Persian: دانشجودانشیار Latest degree: bachelorphd Area of specialty/work: 7772 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Girls' DormitoryTehran, Pich-e Shomiran, School of Rehabilitation, Tehran University of Medical Sciences, Noth Kargar Ave, Amir Abad, Teharn city Street address - Persian: تهران. امیر آبادپیچ شمیران. خیابان کارگر شمالی. خوابگاه دخترانه یدانشکده توانبخشی دانشگاه علوم پزشکی تهران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1439955975 Phone: +98 21 8670 5503 Mobile: +98 914 422 5596912 206 3968 Fax: Email: a-kazemnazhandhamiddalvand@razi.tums.ac.irgmail.com Web page address:
Sharing plan
yes
undecided
yesundecided
yes
undecided
yesundecided
After the study is completed, this data can be published in the form of a spss, if the judges or researchers ask our study group.
Data related to the variables will be made available to the Occupational Therapy Education Research Department and, upon request by the corresponding author, will be provided to them for use in meta-analysis studies.
AfterData related to the study is completed, this data canvariables will be publishedmade available to the Occupational Therapy Education Research Department and, upon request by the corresponding author, will be provided to them for use in the form of a spss, if the judges or researchers ask our study groupmeta-analysis studies.
بعد از اتمام مطالعه این داده ها به صورت فایل spss ، در صورتی که داوران یا محققین از گروه مطالعاتی ما بخواهند، قابل انتشار است.
داده های مربوط به متغیر ها در اختیار بخش پژوهش آموزش کاردرمانی گذاشته می شود و در مطالعات متاآنالیز در ضورت درخواست نویسنده مسئول به ایشان داده میشود.
بعد از اتمام مطالعه اینداده های مربوط به متغیر ها در اختیار بخش پژوهش آموزش کاردرمانی گذاشته می شود و در مطالعات متاآنالیز در ضورت درخواست نویسنده مسئول به ایشان داده ها به صورت فایل spss ، در صورتی که داوران یا محققین از گروه مطالعاتی ما بخواهند، قابل انتشار استمیشود.
We will probably be able to access this data up to a year after the results are published.
The first part, concerning the provision of data to the Occupational Therapy Education group, will be carried out after the article is published. For the second part, data will be sent whenever an official request is received from the authors of meta-analysis studies.
WeThe first part, concerning the provision of data to the Occupational Therapy Education group, will probably be able to access this data up to a yearcarried out after the results arearticle is published. For the second part, data will be sent whenever an official request is received from the authors of meta-analysis studies.
احتمالا حداکثر تا یک سال پس از چاپ نتایج، دسترسی به این داده ها را فراهم خواهیم کرد.
بخش اول که مربوط به در اختیار قرار دادن داده ها به گروه آموزشی کاردرمانی پس از چاپ مقاله انجام می شود و در مورد دوم هر زمان که درخواست رسمی از سوی نویسندگان مقالات متاآنالیز دریافت شود داده ها ارسال می گردد.
احتمالا حداکثر تا یک سالبخش اول که مربوط به در اختیار قرار دادن داده ها به گروه آموزشی کاردرمانی پس از چاپ نتایج، دسترسی به اینمقاله انجام می شود و در مورد دوم هر زمان که درخواست رسمی از سوی نویسندگان مقالات متاآنالیز دریافت شود داده ها را فراهم خواهیم کردارسال می گردد.
To investigate the relationship between variables
For further studies in this field, based on the recommendations provided in the article.
To investigateFor further studies in this field, based on the relationship between variablesrecommendations provided in the article.
برای بررسی ارتباط سنجی بین متغیر ها
برای مطالعات تکمیلی در این حوزه بر اساس پیشنهادات اراِئه شده در مقاله .
برای بررسی ارتباط سنجی بین متغیر هامطالعات تکمیلی در این حوزه بر اساس پیشنهادات اراِئه شده در مقاله .
Researcher of this study: Aida Kazemnazhand Asl. by email: a-kazemnazhand@razi.tums.ac.ir
corresponding author
(Dr. Hamid Dalvand)
Researcher of this study: Aida Kazemnazhand Aslcorresponding author (Dr. by email: a-kazemnazhand@razi.tums.ac.irHamid Dalvand)
با پژوهشگر این مطالعه: آیدا کاظم نژند اصل با ایمیل: a-kazemnazhand@razi.tums.ac.ir
نویسنده مسئول (دکتر حمید دالوند)
با پژوهشگر این مطالعه: آیدا کاظم نژند اصل با ایمیل: a-kazemnazhand@razi.tums.ac.irنویسنده مسئول (دکتر حمید دالوند)
First, email a message to the researcher about the purpose of using the data, along with enough information from the name and address of the researcher. In case of checking the cases and making sure of the maral, it will be sent in a short period of time.
First, a message regarding the purpose of data usage, along with sufficient information about the researcher’s name and contact details, will be emailed to the researcher. If the details are reviewed and the procedures are verified, it will be sent within a short period of time.
First, email a message to the researcher aboutregarding the purpose of using the data usage, along with enoughsufficient information fromabout the researcher’s name and address ofcontact details, will be emailed to the researcher. In case of checkingIf the casesdetails are reviewed and making sure of the maralprocedures are verified, it will be sent inwithin a short period of time.
ابتدا پیامی در رابطه با هدف استفاده از داده ها در کنار اطلاعات کافی از نام و نشانی محقق، به پژوهشگر ایمیل شود. در صورت بررسی موارد و اطمینان از حت مرال، در بازه ی زمانی کوتاهی ارسال خواهد شد.
ابتدا پیامی در رابطه با هدف استفاده از داده ها در کنار اطلاعات کافی از نام و نشانی محقق، به پژوهشگر ایمیل شود. در صورت بررسی موارد و اطمینان از صحت مراحل، در بازه ی زمانی کوتاهی ارسال خواهد شد.
ابتدا پیامی در رابطه با هدف استفاده از داده ها در کنار اطلاعات کافی از نام و نشانی محقق، به پژوهشگر ایمیل شود. در صورت بررسی موارد و اطمینان از حت مرالصحت مراحل، در بازه ی زمانی کوتاهی ارسال خواهد شد.
Protocol summary
Study aim
The effect of computerized visual games on handwriting, visual perception skills and visual-motor integration in children with spastic cerebral palsy in second and third grades of elementary school.
Design
A clinical trial with a control group, parallel groups, one-strain blind, randomized, on 30 children. A stratified permuted block randomization method will be used.
Settings and conduct
The study population is spastic cerebral palsy.
Interventions are in the field of handwriting, visual perception and motor visual integrity.
Interventions in occupational therapy clinics or exceptional schools in Tehran.
Interventions will be computeized visual games ( 20 sessions . Interventions are for individual children. Games will be played on the computer and the child will play these games with the mouse in a quiet environment).
After the end of interventions, final evaluation and then data analysis will be carried out.
The study is a blind type that will be a blind statistical analyzer. The data will be entered by the researcher and the statistical analyzer who does not know the participants will perform these analyses.)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children with spastic cerebral palsy diagnosed by pediatric neuroscience
Exit Criteria: People who do not want to participate in the study at any stage of the study
Intervention groups
One of the intervention groups will receive the visual perception game alongside traditional handwriting exercises. The other intervention group will receive the visual-motor integration game in addition to traditional handwriting exercises, while the third group, serving as the control group, will not receive any of these games and will only perform traditional handwriting exercises.
Update of randomization method, recruitment status, and further clarification of interventions to ensure consistency with the final study protocol and in response to journal requirements.
Acronym
IRCT registration information
IRCT registration number:IRCT20230219057447N1
Registration date:2023-05-25, 1402/03/04
Registration timing:prospective
Last update:2025-09-19, 1404/06/28
Update count:2
Registration date
2023-05-25, 1402/03/04
Registrant information
Name
Aida Kazemnazhand asl
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 2651
Email address
a-kazemnazhand@razi.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2026-09-23, 1405/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Computerized Visual Games on Handwriting, Visual Perception and Visual Motor Integration in the Children with Spastic Cerebral Palsy in the second and third grades of elementary schools.
Public title
The Effect of Computer Vision Games on Handwriting, Visual Perception and Visual Motor Integrity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children with cerebral palsy participating, second and third grade of primary school
Children diagnosed with spastic cerebral palsy by pediatric neuroscience specialty
Children in the gross movement classification system (GMFCS E&R) at levels I, II, III
Children in manual abilities classification system (MACS) at levels I, II, III
Children have the ability to write with pencil
Children with cognitive scores above 70
Children who do not achieve complete scores according to legibility criteria according to Persian Handwriting Test (PHAT)
Children who have difficulty in the Visual Perception Skills Test (TVPS-R), i.e. obtain scores below the defined average
Children who do not achieve complete scores by age in the Visual-Motor Integrity Test (DTVMI)
Exclusion criteria:
Children with modified visual acuity with glasses less than 0.8 in close vision
Children with obvious eye deviation (strabismus)
Children with any kind of orthopedic anomalies, upper extremity surgeries in the last six months or botulinum injections in the last three months
Age
From 8 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
A stratified permuted block randomization method will be used in this trial. Participants will first be stratified based on the type of spastic cerebral palsy into three strata: hemiplegia, diplegia, and quadriplegia. Within each stratum, participants will be randomly assigned to one of the three study groups: Group A (visual-motor integration intervention), Group B (visual perception intervention), and Group C (control group). Thus, randomization will be performed separately within each CP subtype to ensure balance across groups. To achieve allocation concealment, we will use sealed, opaque envelopes made with foil and carbon paper to prevent any visibility of group assignment. Since we are not certain about the exact number of participants in each CP subtype in advance, and to follow recommendations from similar studies (e.g., Doig et al., 2005), we will prepare more than the planned 30 envelopes specifically, 81 envelopes in total, consisting of 27 for each group (A, B, and C). These envelopes will be distributed across three Tupperware-style containers, each labeled according to the CP subtype (hemiplegia, diplegia, quadriplegia). In each container, 9 envelopes from each group (A, B, and C) will be placed (totaling 27 envelopes per stratum). These envelopes will not be mixed between strata. Within each stratum, random blocks of size 3 and 6 will be created, and envelopes will be shuffled within each block. To determine the sequence of blocks, a coin-flipping method will be used: if the coin lands on heads, a block of size 3 will be selected; if tails, a block of size 6. This process will be repeated until a complete block sequence is generated for each stratum. Once the block order is finalized, it will remain fixed. Subsequently, envelopes within each stratum will be numbered sequentially: H1–H27 for hemiplegia, D1–D27 for diplegia, and Q1–Q27 for quadriplegia. As each participant enters the trial, after being classified by CP subtype, the next available envelope in that stratum will be assigned to them in sequence. Importantly, this entire randomization and allocation process will be performed by an independent researcher who is not involved in recruitment, intervention delivery, or outcome assessments, in order to minimize potential bias 54.
Blinding (investigator's opinion)
Single blinded
Blinding description
Considering that all conditions are specified in the consent form, in this study, after grouping, participants will fully understand which group they are in (for the intervention groups, computer games will be provided and no intervention will be provided for the control group) so it is not possible for the participants to blind and in this study only the data analyzers will be blind. To have the possibility of a blind side. In this study, the principal investigator will conduct preliminary assessments as well as post-intervention interventions and evaluations and is aware of the whole study process.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran Medical Sciences Girls' Dormitory, north kargar. amir abad. tehran
City
Tehran
Province
Tehran
Postal code
1439955975
Approval date
2023-04-30, 1402/02/10
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.057
Health conditions studied
1
Description of health condition studied
Cerebral palsy
ICD-10 code
G80
ICD-10 code description
Cerebral palsy
Primary outcomes
1
Description
handwriting
Timepoint
Before the study and after the end of the study (the interval between pre-test and post-test will be 10 weeks)
Method of measurement
Persian Handwriting Assessment Tool (PHAT)
Secondary outcomes
1
Description
Visual-motor integrity
Timepoint
Before the start of the intervention and after the end of the intervention (10 weeks gap between pre-test and post-test)
Method of measurement
the Beery Bactenica visual Motor Integrity Development Test
2
Description
visual percetion
Timepoint
Before the start of the intervention and after the end of the intervention (10 weeks gap between pre-test and post-test)
Method of measurement
Visual Perception Skills Test TVPS-R
3
Description
Cognitive Ability
Timepoint
At the time of determining the entry criteria (before the beginning of the intervention)
Method of measurement
With Sparkle Form
4
Description
Gross Motor Function
Timepoint
At the time of determining the entry criteria (before the beginning of the intervention)
Method of measurement
Gross Movement Classification System GMFCS
5
Description
Ability of the hand
Timepoint
At the time of determining the entry criteria (before the beginning of the intervention)
Method of measurement
Manual Ability Classification System MACS
6
Description
Visual acuity
Timepoint
At the time of determining the entry criteria (before the beginning of the intervention)
Method of measurement
With the Snellen Vision Chart
Intervention groups
1
Description
The first intervention group: In this group consisting of 10 children, visual perception computer games will be presented for 20 sessions. This visual perception game is related to the skills associated with visual perception and involves steps from easy to hard. Visual Perception Games: A series of cards drawn from training books designed as games. These cards have been suggested by occupational therapists, optometrists, educators, learning specialists and other health professionals and their goal is to practice the skills of shape recognition from context, visual recognition, visual stability, visual perfection, visual sequence memory, visual-spatial relationships and visual memory in people who need to improve these skills. In this game, visual perception will be determined for the child at each session and the child will play this game on a computer belonging to the researcher and, in case of error, will receive the necessary guidance from the therapist. These games will be played for 45 minutes each. There will be 2 sessions per week, and after 10 weeks, these 20 sessions will be completed.
Category
Rehabilitation
2
Description
The second intervention group: In this group, which consists of 10 children with cerebral palsy, visual and motor computer games will be presented for 20 sessions.It is designed with German software model (Cog Pack) and consists of 9 different parts with the aim of training visual-motor integration skills. The names of these games are: Sight-Motion, UFO, Ball, Star Fall, Labyrinth, Split Boards and Cakes, Routing and Mirror, each of which has different difficulty levels. In each session, a certain number of these steps are considered. Each session will last 45 minutes. Games on the computer will be played by the child. 2 sessions per week and a total of 10 weeks of interventions will be performed.
Category
Rehabilitation
3
Description
Control group: In this group of 10 children with cerebral palsy, no intervention will be provided.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hasti occupational clinic
Full name of responsible person
Mehdi Bigham
Street address
Sattar Khan. Baqer Khan Street. No. 92.
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 914 422 5596
Email
a-kazemnazhand@razi.tums.ac.ir
2
Recruitment center
Name of recruitment center
Haami occupational clinic
Full name of responsible person
Ghodrat khavari
Street address
Pasdaran. Daoud Eslami Street.Corner of West Gulzar
East 14th Alley, West Ferdows Blvd., Sattari Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 914 422 5596
Email
a-kazemnazhand@razi.tums.ac.ir
6
Recruitment center
Name of recruitment center
Haji Babaei Exceptional School
Full name of responsible person
mr mahmoodi
Street address
kazane St Yari Street
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 914 422 5596
Email
a-kazemnazhand@razi.tums.ac.ir
7
Recruitment center
Name of recruitment center
Imam Reza Exceptional School
Full name of responsible person
mrs. abbasi
Street address
Yakhji Abad Neighborhood - Rezvan, Tehran
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 914 422 5596
Email
a-kazemnazhand@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Tehran. Amir Abad St. North Kargar Street. Tehran Medical Sciences Girls' Dormitory
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 914 422 5596
Email
a-kazemnazhand@razi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
1
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
Tehran University of Medical Sciences
Full name of responsible person
Aida Kazemnazhand Asl
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Girls' Dormitory of Tehran University of Medical Sciences, North Kargar Ave, Amir Abad, Tehran
City
Tehran
Province
Tehran
Postal code
5539955975
Phone
+98 21 8670 5503
Email
a-kazemnazhand@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hamid Dalvand
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Tehran, Pich-e Shomiran, School of Rehabilitation, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 21 8670 5503
Email
hamiddalvand@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aida Kazemnazhand Asl
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Girls' Dormitory of Tehran University of Medical Sciences, North Kargar Ave, Amir Abad, Tehran
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 21 8670 5503
Email
a-kazemnazhand@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Data related to the variables will be made available to the Occupational Therapy Education Research Department and, upon request by the corresponding author, will be provided to them for use in meta-analysis studies.
When the data will become available and for how long
The first part, concerning the provision of data to the Occupational Therapy Education group, will be carried out after the article is published. For the second part, data will be sent whenever an official request is received from the authors of meta-analysis studies.
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
For further studies in this field, based on the recommendations provided in the article.
From where data/document is obtainable
corresponding author
(Dr. Hamid Dalvand)
What processes are involved for a request to access data/document
First, a message regarding the purpose of data usage, along with sufficient information about the researcher’s name and contact details, will be emailed to the researcher. If the details are reviewed and the procedures are verified, it will be sent within a short period of time.