Determining the effect of the heel wedge on genurecurvatum caused by hypermobility
Design
The study is a single group, phase 2, clinical trial that examines the effect of three different heel heights on a group of 15 children with knee hyper-extension.
Settings and conduct
Location of the study: Two elementary schools, one for girls and one for boys, in District 11 of Tehran; study population: 15 individuals; type of blinding: there will be no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Children aged 5 to 10 years, suffering from knee hyperextension greater than 10 degrees but less than 20 degree, with a Beighton score greater than 6.
Exclusion criteria:
Individuals with deformities in the lower limb joints or spine, pain in the lower limb joints within the past two weeks, anterior or posterior cruciate ligament tears, suffering from lower limb injury in the last six months, Individuals with a body mass index (BMI) above 25.
Intervention groups
Children will wear special shoes with the following heel heights: Once without a wedge Once with a 15 mm heel height Once with a 25 mm heel height Once with a 35 mm heel height at the heel.
Main outcome variables
Temporal-Spatial Variables of Walking; Kinematics of the Ankle, Knee, and Hip Joints; Kinetics of the Ankle, Knee, and Hip Joints; Muscle Activity Patterns of the Knee.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240906062959N1
Registration date:2024-12-11, 1403/09/21
Registration timing:prospective
Last update:2024-12-11, 1403/09/21
Update count:0
Registration date
2024-12-11, 1403/09/21
Registrant information
Name
maryam hashemzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5340 2164
Email address
mar.hashemzade@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-13, 1403/10/24
Expected recruitment end date
2025-03-14, 1403/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Immediate Effect of Using a Heel Wedge with Three Different Heights on Knee Hyperextension Caused by Joint Hypermobility.
Public title
Investigating the Effect of Heel Wedges on Gait Correction in Children with Joint Hypermobility
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
5 to 10 years old children
children With knee hyperextension greater than 10 degrees and less than 20 degrees
Children with a Beighton score greater than 6
Exclusion criteria:
Individuals with deformities in the lower limb joints and spine
individuals who have experienced pain in the lower limb joints in the past two weeks
individuals with anterior and posterior cruciate ligament tears
individuals who have suffered a lower limb injury in the last six months
individuals with a body mass index (BMI) above 25
Children under 5 years old and over 10 years old
Age
From 5 years old to 10 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of social welfare and rehabilitation
Street address
University of Rehabilitation Sciences and Health, Kudakiar Dead End, Daneshju Boulevard, Velenjak
City
tehran
Province
Tehran
Postal code
1985713871
Approval date
2024-11-03, 1403/08/13
Ethics committee reference number
IR.USWR.REC.1403.183
Health conditions studied
1
Description of health condition studied
joint hyper mobility , genurecurvatum
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
spatio-temporal parameters
Timepoint
The immediate effect is examined immediately after the intervention
Method of measurement
The calculation of spatial-temporal variables is performed using data obtained from the Vicon motion capture system (Vicon Motion Systems, Oxford, UK) with six cameras operating at a frequency of 120 Hz. The distance and time for each of the subphases of walking will be calculated through the software
2
Description
Kinematics of the Ankle, Knee, and Hip Joints
Timepoint
The immediate effect is examined immediately after the intervention
Method of measurement
The calculation is performed using data obtained from the Vicon motion capture system (Vicon Motion Systems, Oxford, UK) with six cameras operating at a frequency of 120 Hz. This is done in such a way that after defining each segment, the variations in joint angles are calculated using software
3
Description
kinetics of the Ankle, Knee, and Hip Joints
Timepoint
The immediate effect is examined immediately after the intervention
Method of measurement
The torque generated around each joint is calculated using the data obtained from the force plate, which involves the ground reaction force multiplied by its distance from the center of the joint
4
Description
Muscle Activity Pattern of the Knee Joint
Timepoint
The immediate effect is examined immediately after the intervention
Method of measurement
Muscle activity is measured using a 48-channel Aktos electromyography device manufactured by Myon, with bipolar surface electrodes synchronized with the force plate
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Shoes without heel and shoes with three different heights of 15 mm, 25 mm, and 35 mm, heel wedge. For each child in the intervention group, a pair of long boots made of synthetic leather will be prepared according to the length of their feet. The shoe design will incorporate a conventional orthopedic insole made of polyurethane that supports the longitudinal arch inside the shoe, and specially designed wedges for each size will be used in the external sole of the shoe. The design of the wedges will ensure that they end before the metatarsal heads, specifically at the break point of the shoe at the toe, reaching their minimum diameter. The wedges will be constructed with heights of 15 mm, 25 mm, and 35 mm at the heel. The height of the wedges on both the inner and outer sides will be equal to each other up to the end, starting from the heel and decreasing as it approaches the front of the foot, finishing before reaching the metatarsal heads. The design and construction of the wedges will be done using a molding device tailored to the shoe size by an orthotics specialist. Three heights for each size will be prepared that can be attached to the midsole of the shoe using double-sided tape. The children will be asked to wear the special shoes once without a wedge, once with a 15 mm heel wedge, once with a 25 mm heel wedge, and once with a 35 mm heel wedge. It is important to note that the order of wearing the shoes will be in a randomized block design. After assigning the type of height, measurements for each height will be taken with three repetitions. Each child will wear the shoes and the different heights of heel wedges in the specified order, and the walking test will be repeated three times for each height. A 20-second rest period will be provided between each intervention to prevent fatigue
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Boy and Girls' Schools in District 11, Tehran
Full name of responsible person
Maryam Hashemzadeh
Street address
University of Rehabilitation Sciences and Health, Kudakiar Dead End, Daneshju Boulevard, Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 913 208 2214
Email
hashemimaryam7071@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr Mohamad Saeed Khanjani
Street address
University of Rehabilitation Sciences and Health, Kudakiar Dead End, Daneshju Boulevard, Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2832
Email
rd@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Maryam Hashemzadeh
Position
Ph.D candidate
Latest degree
Master
Other areas of specialty/work
orthotics and prosthetics
Street address
University of Rehabilitation Sciences and Health, Kudakiar Dead End, Daneshju Boulevard, Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2832
Email
hashemimaryam7071@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Maryam Hashemzadeh
Position
phd student
Latest degree
Master
Other areas of specialty/work
orthotics and prosthetics
Street address
University of Rehabilitation Sciences and Health, Kudakiar Dead End, Daneshju Boulevard, Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2832
Email
hashemimaryam7071@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Maryam Hashemzadeh
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
orthotics and prosthetics
Street address
University of Rehabilitation Sciences and Health, Kudakiar Dead End, Daneshju Boulevard, Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2832
Email
hashemimaryam7071@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
Undecided - It is not yet known if there will be a plan to make this available