Foot orthoses are often used to correct altered gait patterns. Most of the previous studies investigated the immediate effects of foot orthoses on biomechanical variables during walking. The aim of the present study was to evaluate the long term use of arch support foot orthoses on lower limb kinematics and kinetics during walking in children with flexible flat feet. 15 children with flexible flat feet (age range between 9-11 years) as a experimental group will be used arch support foot orthoses for 4 months. In the control group foot orthoses will be used for 4 months. Walking kinematic and kinetics will be recorded by vicon camera systems and Kistler forceplatform before and after of 4 months. ANOVA repeated measure will be used for statistical analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082235517N1
Registration date:2017-09-04, 1396/06/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-04, 1396/06/13
Registrant information
Name
AmirAli Jafarnezhadgero
Name of organization / entity
University of Mohaghegh Ardabili
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 0903
Email address
a.jafarnezhad@uma.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Mohaghegh Ardabili
Expected recruitment start date
2017-09-04, 1396/06/13
Expected recruitment end date
2018-01-10, 1396/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of long term use of arch support foot orthoses on lower limb kinematics and kinetics during walking in children with flexible flat foot
Public title
Effects of long term use of arch support foot orthoses on lower limb kinematics and kinetics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age range between 9-12 years; Flexible flat feet; Male.
Exclusion criteria: History of lower limb injury; History of surgery.
Age
From 9 years old to 12 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil university of Medical Sciences
Street address
Ardabil province- Ardabil city-Ardabil university of medical sciences
City
Ardabil
Postal code
Approval date
2017-08-20, 1396/05/29
Ethics committee reference number
IR-ARUMS-REC-1396-90
Health conditions studied
1
Description of health condition studied
Flexible flat foot
ICD-10 code
M21.4
ICD-10 code description
Flat foot [pes planus] (acquired)
Primary outcomes
1
Description
Walking kinematics
Timepoint
before and after 4 months
Method of measurement
Vicon cameras
2
Description
Walking kinetics
Timepoint
before and after 4 months
Method of measurement
Force platform
Secondary outcomes
1
Description
Ground reaction forces
Timepoint
before and after 4 months
Method of measurement
Forceplatform
Intervention groups
1
Description
Intervention group: 4 months use of arch support foot orthoses
Category
Rehabilitation
2
Description
Control group: long term use of placebo orthoses
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Schools
Full name of responsible person
Street address
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
AmirAli Jafarnezhadgero
Street address
Physical education and sport sciences department, Mohaghegh Ardabili University, Ardabil, Iran,
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mohaghegh Ardabili University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
AmirAli Jafarnezhadgero
Position
Assistant professor/ Phd
Other areas of specialty/work
Street address
Ardabil province-Ardabil-Mohaghegh Ardabili University
City
Ardabil
Postal code
Phone
+98 45 3351 0903
Fax
Email
amiralijafarnezhad@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
AmirAli Jafarnezhadgero
Position
Assistant professor/Phd
Other areas of specialty/work
Street address
Physical education and sport sciences department, Mohaghegh Ardabili University, Ardabil, Iran,
City
Ardabil
Postal code
Phone
+98 45 3351 0903
Fax
Email
amiralijafarnezhad@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
AmirAli Jafarnezhadgero
Position
PhD
Other areas of specialty/work
Street address
Ardabil province- Ardabil city- Mohaghegh Ardabili University
City
Ardabil
Postal code
Phone
+98 45 3351 0903
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)