Protocol summary
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Study aim
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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.
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Design
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Clinical trial with control group, without blinding, randomized. Coin toss was used for randomization.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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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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Acronym
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IRCT registration information
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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
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Registration date
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2021-09-06, 1400/06/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-09-23, 1400/07/01
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Expected recruitment end date
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2021-12-21, 1400/09/30
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Actual recruitment start date
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2021-09-23, 1400/07/01
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Actual recruitment end date
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2022-02-09, 1400/11/20
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Trial completion date
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2022-03-16, 1400/12/25
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Scientific title
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The effect of gait plates on spatio-temporal parameters of gait and foot progression angle of in-toeing gait children
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Public title
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The effect of gait plates on in-toeing gait children
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 3 years old to 10 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
20
Actual sample size reached:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Factorial
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-08-25, 1400/06/03
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Ethics committee reference number
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IR.USWR.REC.1400.123
Health conditions studied
1
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Description of health condition studied
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intoeing gait
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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foot progression angle
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Timepoint
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Measure the foot progression angle immediately and one month after using the gait plate insole
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Method of measurement
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Measure the midline of the shoeprints on the paper aisle
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Master degree Proposal
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Proportion provided by this source
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1
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available