The effect of medial longitudinal arch support and UCBL on the torque of the knee joint in children with flexible plantar fasciitis
Design
Clinical trial with parallel groups, one-way blind, randomized,
Settings and conduct
This study is a parallel clinical trial. Available sampling method is performed from people referring to the centers belonged to Isfahan University of Medical Sciences in 2020 for 3 months. After filtering from inclusion and exclusion criteria in the biomechanics laboratory of the Rehabilitation Faculty of Isfahan University of Medical Sciences, individuals are randomly divided into two intervention groups A and B and are scanned with a 3D scanner to make the sole of the foot. After applying the changes, the insole file is transferred to the 3D printer machine in order to make the insole.
Participants/Inclusion and exclusion criteria
1) Flexible flat foot with foot posture index above 9 on both feet
2) Range of age between 8-11 years
3) Genovalgum more than 6 degrees
4) Genovalgum less than 12 degrees (mild)
5) Do not use insoles and other orthoses in the past
Intervention groups
Subjects will participate in the study in two different modes of intervention (medial longitudinal arch support insole, with UCBL ) and one mode without intervention in walking position.
Main outcome variables
knee adduction moment arm, medical insole with medial longitudinal arch support
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200516047459N1
Registration date:2020-10-03, 1399/07/12
Registration timing:retrospective
Last update:2020-10-03, 1399/07/12
Update count:0
Registration date
2020-10-03, 1399/07/12
Registrant information
Name
Masoud Rafiaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5043
Email address
ma.rafiaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
2020-05-21, 1399/03/01
Actual recruitment end date
2020-08-21, 1399/05/31
Trial completion date
2020-11-20, 1399/08/30
Scientific title
The effect of medial longitudinal arch support and UCBL in knee adduction moment arm in children with flexible flat foot.
Public title
The effect of two types of medical insoles on knee torque in children with flat feet
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Flexible flat foot with foot posture index above 9 on both feet
Range of age between 8-11 years
Genovalgum more than 6 degrees
Genovalgum less than 12 degrees (mild)
Do not use insoles and other orthoses in the past
Exclusion criteria:
Age
From 8 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
15
Actual sample size reached:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants are in two groups and the type of insole is not known to them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Isfahan University of Medical Sciences
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-02-09, 1398/11/20
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.097
Health conditions studied
1
Description of health condition studied
flexible flat foot
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
knee adduction moment arm
Timepoint
Before and immediate after
Method of measurement
Force plate
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: subjects that use medical insole with medial longitudinal arch support
Category
Rehabilitation
2
Description
Intervention group: subjects that use UCBL insole
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Centers affiliated to Isfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Information is confidential.
Study Protocol
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Print article
When the data will become available and for how long
9 months
To whom data/document is available
writers
Under which criteria data/document could be used
Documentation will be available if used in future studies.
From where data/document is obtainable
corresponding author
What processes are involved for a request to access data/document