Comparison of the effect of gate plate insole and medial-wedge insole on balance and angle of gait of in-toeing child
Design
The clinical trial with a sample size of 30 children, two intervention groups, With parallel groups, triple blinded, randomized by block randomization method.
Settings and conduct
Children are randomly divided into two groups. For the first group, the gate plate insole and the second group, the medial-wedge insole are designed and made. The velocity and displacement of the center of pressure and the angle of gait are measured by force plate and motion analysis system before intervention and one month after intervention in Shiraz Rehabilitation School, respectively. Subjects, researcher and statistical analyst are not aware of the type of intervention assigned.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Angle of gait less than -3 degrees, in-toeing gait due to excessive femoral anteversion and internal tibia torsion
Exclusion criteria: In-toeing gait due to metatarsus adductus, severe deformities in lower limbs, history of surgery or fracture in lower limbs
Intervention groups
The clinical trial has two groups. The children of the first group will receive a gate plate insole and the second group will receive a medial-wedge insole.
Main outcome variables
Center of pressure displacement; velocity of center of pressure displacement; angle of gait
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210419051014N1
Registration date:2021-06-18, 1400/03/28
Registration timing:registered_while_recruiting
Last update:2021-06-18, 1400/03/28
Update count:0
Registration date
2021-06-18, 1400/03/28
Registrant information
Name
Farzaneh Manouchehri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7173 2000
Email address
fa.manouchehri@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-14, 1399/11/26
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of gait plate insole and medial-wedge insole on balance and angle of gait of the in-toeing child
Public title
The effect of gait plate insole and medial-wedge insole for children with in-toeing gait
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pediatric population with an intoed gait
In-toeing gait due to excessive femoral anteversion (internal rotation of the hip greater than 70 degrees)
In-toeing gait due to internal tibia torsion (negative values of thigh-foot angle)
Angle of gait less than -3 degrees
Being 3 to 10 years old
Exclusion criteria:
In-toeing gait due to Cerebral Palsy
In-toeing gait due to metatarsus adductus
Severe deformities in lower limbs, for example, clubfoot, congenital hip joint dislocation, equinus of the foot and congenital flat foot
History of surgery or fracture in lower limbs
Neurological (Cerebral Palsy and Charcot Marie Thoth) and neuromuscular diseases
Using medical shoes and orthoses
Lack of children’s and/or parents’ consent to cooperate
Age
From 3 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method is used. This method is used to balance the number of samples assigned to each of the study groups. In this study, considering that we have two groups, blocks with size of 4 are used. The randomization tool is used is random allocation software that is able to generate random sequences by block randomization method. Group assignment is hidden in dark, sealed envelopes that are numbered consecutively. At the beginning of the registration of participants, according to the order of entry of eligible participants into the study, one of the envelopes is opened in order and the assigned group of that participant is revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Subjects and researchers are not aware of the type of insole allocated. The person analyzing the data is unaware of the study and examines the data in general.
Placebo
Not used
Assignment
Parallel
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
University of Social Welfare and Rehabilitation Science, Kodakyar Dead End., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2020-09-12, 1399/06/22
Ethics committee reference number
IR.USWR.REC.1399.160
Health conditions studied
1
Description of health condition studied
Intoeing gait pattern
ICD-10 code
R26.8
ICD-10 code description
Other abnormalities of gait and mobility
Primary outcomes
1
Description
Center of pressure displacement
Timepoint
Measurement of the displacement of center of pressure at the beginning of the study (before the intervention) and one month after using the gate plate insole or medial-wedge insole
Method of measurement
Force plate instrument
2
Description
Velocity of center of pressure displacement
Timepoint
Measure the velocity of center of pressure displacement at the beginning of the study (before the intervention) and one month after using the gate plate insole or medial-wedge insole
Method of measurement
Force plate instrument
3
Description
Angle of gait
Timepoint
Measure the angle of gait at the beginning of the study (before the intervention) and one month after using the gate plate insole or medial-wedge insole
Method of measurement
Motion analysis system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: The first group will receive a gate plate insole. It is a rigid plastic shell that covers the plantar area, with an extension beyond fourth and fifth metatarsal heads. Gate plate insoles were made-to-order and customized to the foot of each child. Children should use the insole for at least 4 hours a day for a month.
Category
Treatment - Devices
2
Description
Intervention group2: The second group receive a medial-wedge insole. The medial-wedge insole with a height of 5 mm and an arch support extending from heel to toe made of ethylene-vinyl acetate were made-to-order and customized to the foot of each child. Children should use the insole for at least 4 hours a day for a month.