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General information
Supportive
Treatment
supcrtreat
empty
45
45
empty
2021-09-23, 1400/07/01
2021-09-23 00:00:00
empty
2022-02-09, 1400/11/20
2022-02-09 00:00:00
empty
2022-03-16, 1400/12/25
2022-03-16 00:00:00
empty
The method of randomization was changed from block to simple because according to the researcher, this method reduces the possibility of biasing the results.
The main condition of not entering the study before randomization - English was added because it was previously forgotten.
Explanation about concealment: None. Because this study was not blinded.
The main purpose of the study was changed to treatment because it is more consistent with the research topic.
The tick of the patient recruitment is terminated option is activated because the patient recruitment has been terminated.
The start and end dates of the realized sick leave were added.
The trial termination date was added.
The method of randomization was changed from block to simple because according to the researcher, this method reduces the possibility of biasing the results. The main condition of not entering the study before randomization - English was added because it was previously forgotten. Explanation about concealment: None. Because this study was not blinded. The main purpose of the study was changed to treatment because it is more consistent with the research topic. The tick of the patient recruitment is terminated option is activated because the patient recruitment has been terminated. The start and end dates of the realized sick leave were added. The trial termination date was added.
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نحوه تصادفی سازی از بلوکی به ساده تغییر یافت چرا که از نظر محقق این روش احتمال سوگیری نتایج را کاهش میدهد.
شرایط عمده عدم ورود به مطالعه قبل از تصادفی سازی - انگلیسی افزوده شد چرا که قبلا فراموش شده بود.
توضیح درباره پنهان سازی: ندارد. چرا که این مطالعه کورسازی نداشت.
هدف اصلی مطالعه به درمانی تغییر یافت چرا که با موضوع تحقیق تطابق بیشتری دارد.
تیک گزینه بیمار گیری خاتمه یافته است فعال شد چرا که بیمارگیری خاتمه یافته است.
تاریخهای شروع و پایان بیمارگیری تحقق یافته افزوده شد.
تاریخ خاتمه کارآزمایی افزوده شد.
نحوه تصادفی سازی از بلوکی به ساده تغییر یافت چرا که از نظر محقق این روش احتمال سوگیری نتایج را کاهش میدهد. شرایط عمده عدم ورود به مطالعه قبل از تصادفی سازی - انگلیسی افزوده شد چرا که قبلا فراموش شده بود. توضیح درباره پنهان سازی: ندارد. چرا که این مطالعه کورسازی نداشت. هدف اصلی مطالعه به درمانی تغییر یافت چرا که با موضوع تحقیق تطابق بیشتری دارد. تیک گزینه بیمار گیری خاتمه یافته است فعال شد چرا که بیمارگیری خاتمه یافته است. تاریخهای شروع و پایان بیمارگیری تحقق یافته افزوده شد. تاریخ خاتمه کارآزمایی افزوده شد.
Participants were excluded from the study if 1) they suffered or had suffered from motor alterations or serious deformities in the lower limb that would affect gait, such as infantile cerebral paralysis, neuromotor alterations in the lower limb, osteochondrosis with serious sequelae, congenital luxation of the hip, equinus foot, rocker-bottom foot, congenital convex flatfoot, clubfoot, and serious varus forefoot
had been surgically treated in the lower limb (bone surgery, osteoarticular surgery, or surgery of the neuromuscular tissue)
presented with in-toeing requiring surgical treatment.
Lack of consent of the child and parents to continue cooperation
Participants were excluded from the study if 1) they suffered or had suffered from motor alterations or serious deformities in the lower limb that would affect gait, such as infantile cerebral paralysis, neuromotor alterations in the lower limb, osteochondrosis with serious sequelae, congenital luxation of the hip, equinus foot, rocker-bottom foot, congenital convex flatfoot, clubfoot, and serious varus forefoot had been surgically treated in the lower limb (bone surgery, osteoarticular surgery, or surgery of the neuromuscular tissue) presented with in-toeing requiring surgical treatment. Lack of consent of the child and parents to continue cooperation
Randomization method and descriptions of each method: block randomization, two blocks (intervention and control), each block includes10 people
Randomization unit: individual
Randomization tool: Coin toss, face for the intervention group and behind for the control group
How to build a random sequence: central randomization
Explanation about allocation concealment: The relevant centers will be contacted by phone and a question will be asked about the allocation of the participant to a specific group.
Randomization method and descriptions of each method: Simple randomization
Randomization unit: individual
Randomization tool: Coin toss, face for the intervention group and behind for the control group
How to build a random sequence: central randomization
Explanation about allocation concealment: N/A
Randomization method and descriptions of each method: blockSimple randomization, two blocks (intervention and control), each block includes10 people Randomization unit: individual Randomization tool: Coin toss, face for the intervention group and behind for the control group How to build a random sequence: central randomization Explanation about allocation concealment: The relevant centers will be contacted by phone and a question will be asked about the allocation of the participant to a specific group.N/A
روش تصادفی سازی و توضیحات هر روش: تصادفی سازی بلوکی، دو بلوک (مداخله و کنترل)، هر بلوک شامل 10 نفر
واحد تصادفی سازی: فرد
ابزار تصادفی سازی: پرتاب سکه، رو برای گروه مداخله و پشت برای گروه کنترل
نحوه ساخت توالی تصادفی: تصادفی سازی مرکزی (Central randomization)،
توضیح درباره پنهان سازی: با مراکز مربوطه بصورت تلفنی تماس گرفته و در مورد تخصیص شرکت کننده به گروه خاص سوال پرسیده خواهد شد.
روش تصادفی سازی و توضیحات هر روش: تصادفی سازی ساده
واحد تصادفی سازی: فرد
ابزار تصادفی سازی: پرتاب سکه، رو برای گروه مداخله و پشت برای گروه کنترل
نحوه ساخت توالی تصادفی: تصادفی سازی مرکزی (Central randomization)،
توضیح درباره پنهان سازی: ندارد.
روش تصادفی سازی و توضیحات هر روش: تصادفی سازی بلوکی، دو بلوک (مداخله و کنترل)، هر بلوک شامل 10 نفرساده واحد تصادفی سازی: فرد ابزار تصادفی سازی: پرتاب سکه، رو برای گروه مداخله و پشت برای گروه کنترل نحوه ساخت توالی تصادفی: تصادفی سازی مرکزی (Central randomization)، توضیح درباره پنهان سازی: با مراکز مربوطه بصورت تلفنی تماس گرفته و در مورد تخصیص شرکت کننده به گروه خاص سوال پرسیده خواهد شدندارد.
Protocol summary
Study aim
The aim of this study is investigating the effect of "gate plate" insole on "foot progression angle" and "temporal-spatial parameters" of children with intoeing gait over a period of one month. In this study the positive and negative effects of the gate plate insole on the gait parameters, in addition to the foot progression angle, will be measured.
Design
Clinical trial with control group, without blinding, randomized. Coin toss was used for randomization.
Settings and conduct
The research will be conducted in children's medical centers. The child will walk with shoes on a paper walk way to record footprints.The child will be filmed walking at the same time.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Children 3 to 10 years old؛ Intoeing gait pattern on both feet؛ Foot progression angle is less than -3 degrees؛ Intoeing gait pattern due to increased or permanent internal tibial torsion or increased or permanent femoral anteversion or both
Exclusion criteria:
Having or a history of severe motor changes or deformities in the lower extremities that affect gait؛ History of fracture and surgical treatment of the lower limb. Surgical treatment such as bone surgery, osteoarticular surgery or neuromuscular tissue surgery؛ Intoeing for reasons that require surgery
Intervention groups
The intervention group includes children 3 to 10 years old who have intoeing. The intervention group will be given a gait plate insole to investigate its effect on gait parameters.
Main outcome variables
The effect of the gate plate insole on the forward angle of the foot will be determined. The effect of the gate plate insole on the temporal-spatial parameters of walking will be determined.
General information
Reason for update
The method of randomization was changed from block to simple because according to the researcher, this method reduces the possibility of biasing the results.
The main condition of not entering the study before randomization - English was added because it was previously forgotten.
Explanation about concealment: None. Because this study was not blinded.
The main purpose of the study was changed to treatment because it is more consistent with the research topic.
The tick of the patient recruitment is terminated option is activated because the patient recruitment has been terminated.
The start and end dates of the realized sick leave were added.
The trial termination date was added.
Acronym
IRCT registration information
IRCT registration number:IRCT20210830052340N1
Registration date:2021-09-06, 1400/06/15
Registration timing:prospective
Last update:2022-07-10, 1401/04/19
Update count:1
Registration date
2021-09-06, 1400/06/15
Registrant information
Name
Vahid Pourmoghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3381 1280
Email address
vah.pourmoghadam@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
2021-09-23, 1400/07/01
Actual recruitment end date
2022-02-09, 1400/11/20
Trial completion date
2022-03-16, 1400/12/25
Scientific title
The effect of gait plates on spatio-temporal parameters of gait and foot progression angle of in-toeing gait children
Public title
The effect of gait plates on in-toeing gait children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 3 to 10 years old
intoeing gait Pattern in both feet
foot Progression angle less than 3 degrees
intoeing gait Pattern due to increased or permanent internal tibial torsion or increased or permanent femural anteversion or both
Exclusion criteria:
Participants were excluded from the study if 1) they suffered or had suffered from motor alterations or serious deformities in the lower limb that would affect gait, such as infantile cerebral paralysis, neuromotor alterations in the lower limb, osteochondrosis with serious sequelae, congenital luxation of the hip, equinus foot, rocker-bottom foot, congenital convex flatfoot, clubfoot, and serious varus forefoot
had been surgically treated in the lower limb (bone surgery, osteoarticular surgery, or surgery of the neuromuscular tissue)
presented with in-toeing requiring surgical treatment.
Lack of consent of the child and parents to continue cooperation
Age
From 3 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method and descriptions of each method: Simple randomization
Randomization unit: individual
Randomization tool: Coin toss, face for the intervention group and behind for the control group
How to build a random sequence: central randomization
Explanation about allocation concealment: N/A
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2021-08-25, 1400/06/03
Ethics committee reference number
IR.USWR.REC.1400.123
Health conditions studied
1
Description of health condition studied
intoeing gait
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
foot progression angle
Timepoint
Measure the foot progression angle immediately and one month after using the gait plate insole
Method of measurement
Measure the midline of the shoeprints on the paper aisle
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Children who will wear a gate plate for a month. The gate plate insole is a rigid thermoplastic insole made of polypropylene sheet with a thickness of 3 mm, which is placed in the shoe and covers the entire sole of the foot up to the metatarsal heads.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalifard rehabilitation
Full name of responsible person
Habib Afzalifard
Street address
Thirty meters street, Next to Negin Hotel
City
Ardabil
Province
Ardabil
Postal code
5685713871
Phone
+98 45 3381 1280
Email
greatlack@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Vice President for Research and Technology
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
international_affairs@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Master degree Proposal
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Vahid Pourmoghadam
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Orthopedics
Street address
kodakyar Ave., daneshjo Blvd.,Evin,
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 935 749 8777
Email
greatlack@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
ٰVahid pourmoghadam
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Orthopedics
Street address
kodakyar Ave., daneshjo Blvd.,Evin,
City
tehran
Province
Tehran
Postal code
1985713871
Phone
+98 935 749 8777
Email
greatlack@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Vahid Pourmoghadam
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Orthopedics
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
tehran
Province
Tehran
Postal code
1985713871
Phone
+98 935 749 8777
Email
greatlack@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