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Comparison of the effect of medial longitudinal arch support with and without night Knee-Ankle-Foot orthosis (KAFO) on changes and correction of genu valgum in children less than ten years old

Protocol summary

Study aim
Comparison of the effect of night knee-ankle-foot orthosis (KAFO) with medial longitudinal arch support with medial longitudinal arch support alone in correction and changes of geno valgum in children under 10 years
Design
The present study is a clinical trial with a control group, with parallel, non-blind, randomized groups by Hidden sealed envelope method, study phase 2-3 where the sample size is determined by the pilot study.
Settings and conduct
In this study, children with geno valgum who are referred to the physical medicine and rehabilitation center of Firoozgar and Rasoul Akram hospitals are evaluated.Patients are randomly divided into two groups by Hidden sealed envelope method. In initial Alignment view XRay, the angles of the medial proximal tibia, lateral distal femur, Intercondylar distance, and lower extremity length are measured.For six months, patients in the first group, in addition to night orthosis, are prescribed a medial longitudinal arch support, and the second group is prescribed a medial longitudinal arch support. After six months, the Alignment View XRay is taken again and the mentioned angles are measured.
Participants/Inclusion and exclusion criteria
Children under 10 years with non-physiological genu valgum with or without a flexible flat foot are imported. Geno valgum caused by neuromuscular diseases or fractures are removed.
Intervention groups
Intervention 1 includes: night knee-ankle-foot orthosis (KAFO) with medial longitudinal arch support Intervention 2 includes: medial longitudinal arch support alone.
Main outcome variables
Medial proximal tibial angles, lateral distal femur, Intercondylar distance, and lower extremity lengths are measured.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170910036107N7
Registration date: 2021-09-28, 1400/07/06
Registration timing: prospective

Last update: 2021-09-28, 1400/07/06
Update count: 0
Registration date
2021-09-28, 1400/07/06
Registrant information
Name
Naseh Yousefi
Name of organization / entity
Iran university of medical science and health services
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 6574
Email address
nasehusefi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of medial longitudinal arch support with and without night Knee-Ankle-Foot orthosis (KAFO) on changes and correction of genu valgum in children less than ten years old
Public title
Comparison of the effect of medial longitudinal arch support with and without night Knee-Ankle-Foot orthosis (KAFO) on changes and correction of genu valgum in children less than ten years old
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 10 years and younger Angular deformity of the valgus around the knee in the coronal plate for no other reason than deformity such as trauma, or any neuromuscular disease
Exclusion criteria:
inflexible flat foot Physiological geno valgum History of lower limb bone surgery
Age
To 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups by Hidden sealed envelope randomization method. In such a way, an equal number of interventions are written in the same size sheets and the sheet is folded in such a way that the type of intervention is not clear. If the patient is selected for the study, parents will randomly pick up a sheet of envelope indicating the type of intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-06-22, 1400/04/01
Ethics committee reference number
IR.IUMS.FMD.REC.1400.222

Health conditions studied

1

Description of health condition studied
Genu valgum
ICD-10 code
M21.06
ICD-10 code description
Valgus deformity, not elsewhere classified, knee

Primary outcomes

1

Description
Proximal medial tibia angle
Timepoint
Before the intervention and 6 months after treatment
Method of measurement
X-ray

2

Description
Lateral femoral distal angle
Timepoint
Before the intervention and 6 months after treatment
Method of measurement
X-ray

3

Description
Intercondylar distance
Timepoint
فاصله اینترکوندیلار
Method of measurement
X-ray

4

Description
Lower limb length
Timepoint
Before the intervention and 6 months after treatment
Method of measurement
X-ray

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: knight Knee-Ankle-Foot orthosis (KAFO) with medial longitudinal arch support insole. Knight Knee-Ankle-Foot orthosis (KAFO) is made by measuring method. It is measured from the inside of the gluteal to the knee, from the knee to the ankle, and the length of each person's foot. Knight Knee-Ankle-Foot orthosis (KAFO) has a cuff in the thigh area and a Ankle-Foot orthosis (AFO) made of polyethylene, which are connected by two steel rods on both sides. The mechanism of action of knight Knee-Ankle-Foot orthosis (KAFO) is a system of three pressure points, two points of pressure on the outside of the foot and above and below the knee joint and one point on the opposite side in the area of the knee joint. In this orthosis, the knee is placed at a zero degree angle without movement and the ankle is placed at a 90 degree angle.The insole is made of polyurethane (PU) with medial longitudinal arch support, by scanning the feet of individuals. To make this insole Computer-aided design (CAD) and Computer-aided manufacturing (CAM) method is used.
Category
Treatment - Devices

2

Description
Second intervention group: Medial longitudinal arch support insole.The insole is made of polyurethane (PU) with medial longitudinal arch support, by scanning the feet of individuals. To make this insole Computer-aided design (CAD) and Computer-aided manufacturing (CAM) method is used.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Firozgar hospital
Full name of responsible person
Narges Mahdizade
Street address
Beh Afarin St., Karim Khan Zand St., Valiasr Square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1201
Email
h_firoozgar@yahoo.com

2

Recruitment center
Name of recruitment center
Rasol Akram hospital
Full name of responsible person
Narges Mahdizade
Street address
Rasoul Akram Hospital, Niayesh St., Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 8811
Email
RCRDC.TEAM@GMAIL.COM

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abas Motevalian
Street address
Iran University of Medical SciencesIran, next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2513
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
Narges Mahdizade
Position
Assistance
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
nargesmhz1369@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naseh Usefi
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
nasehusefi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Narges Mahdizade
Position
Assistance
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
nargesmhz1369@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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