Comparision the effect of gait plate insole and lateral sole wedged shoes on foot progression angle in children with in-toeing gait
Design
Randomized controlled trial, two parallel groups with no blinding, 30 patient
Settings and conduct
This study is being conducted at the rehabilitation faculty of Iran University of medical science.
Rotational profile tests are performed to determine the cause of in-toeing gait.
The type of intervention (gait plate insole/shoe with lateral sole wedge) will be selected randomly.
Children are asked to walk on the scanner plate by self selected speed with and without intervention.
All tests will be repeated 5 times to determine an average of the angle of gait.
Children will be asked to use and walk with their intervention (gait plate insole/shoe with lateral sole wedge) for 4 weeks.
Walking test with and without intervention will be repeated after 4 week similar to previous tests.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- angle of gait less than -3
2- positive rotational profile tests
3- anteversion more than 70 degree
exclusion criteria:
1- severe deformity that need surgery
2- history of surgery on lower limb
3-history of fracture in lower limb
4- history of using orthopedic shoes or braces
5- neuromuscular and neurological diseases
6- history of deformities that effects angle of gait such as club foot and DDH
7- intoeing because of metatarsus adductus or internal tibial torsion
Intervention groups
first intervention- gait plate insole
second intervention- shoe with lateral sole wedge
Main outcome variables
Angle of gait
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140219016643N8
Registration date:2020-07-22, 1399/05/01
Registration timing:retrospective
Last update:2020-07-22, 1399/05/01
Update count:0
Registration date
2020-07-22, 1399/05/01
Registrant information
Name
Behshid Farahmand
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0947
Email address
farahmand.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-27, 1398/09/06
Expected recruitment end date
2020-04-25, 1399/02/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision the effect of gait plate insole and lateral sole wedged shoes on foot progression angle in children with in-toeing gait
Public title
Comparision the effect of gait plate insole and lateral sole wedged shoes on foot progression angle in children with in-toeing gait
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
less than -3 degree angle of gait
positive rotational profile tests
more than 70 degree anteversion
Exclusion criteria:
sever deformities candidate if surgery
surgical history on lower limbs
fractures history on lower limbs
using orthotic devices or orthopedic shoes history
neurologic or neuromuscular disease
deformities on lower limb history such as club foot or ddh
intoeing because of metatarsus adductus or internal tibial torsion
Age
From 5 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be asked to pick up a card (treatment on it) from a box (chance of choosing any treatment is equal).
before intervention, immediately after intervention, after 4 weeks of using the intervention
Method of measurement
using RS scan to evaluate angle of gait
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: gait plates insole. This insole is made from a cast of the child’s feet in a subtalar neutral position and 3-mm diameter thermoplastic sheet. Distally the insole is extended behind the first metatarsal head medially, and at an angle of 45 degrees beyond the fourth and fifth metatarsal heads laterally.
Category
Treatment - Devices
2
Description
second Intervention group: Shoe with lateral sole wedge. This shoe is made of leather with rubber outsole. 3 mm rubber wedge is placed in the forefoot area at the lateral side of the outsole.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Rehabilitation Sciences of Iran University
Hemat Highway, next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
Research@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
Behshid Farahmamd
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Mather squre, Abkar Shahnazari Street, Madadkaran street, Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Email
Farahmand.b@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behshid Farahmamd
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Mather Squre, Abkar Shahnazari Street, Madadkaran street, Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Email
Farahmand.b@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behshid Farahmamd
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Mather Squre, Abkar Shahnazari Street, Madadkaran Street, Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Email
Farahmand.b@iums.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Comparision the effect of gait plate insole and lateral sole wedged shoes on foot progression angle in children with in-toeing gait
When the data will become available and for how long
The start access is determined according to the law of the journal which the article is submitted
To whom data/document is available
Accessibility for all people
Under which criteria data/document could be used
Do not consider a particular item
From where data/document is obtainable
Contact by e-mail of corresponding author
What processes are involved for a request to access data/document
If there is no precautionary statement from the journal which the article is printed, with contact by e-mail of corresponding author, information will be sent to the requesting person within less than one month