Evaluation of the effect of night orthosis on foot and ankle biomechanics in children with flexible flatfoot and gastro-soleus stiffness: Based on Randomized clinical trial
Determining the effectiveness of night orthosis on the gastrosoleus stiffness and kinematics during walking in children with flexible flatfoot and gastro-soleus stiffness
Design
A randomized clinical trial with parallel groups and control group, one-way blinded, on 20 patients. Statistical software was used for randomization
Settings and conduct
This study will be performed at Isfahan University of Medical Sciences. biodex isokinetic device and motion analysis were used
Participants/Inclusion and exclusion criteria
children with flexible flatfoot and gastrosoleus stiffness and without any problems or trauma to the lower limb
Intervention groups
The control group gastrosoleus muscle stretching exercise and the intervention group night orthosis in addition to gastrosoleus muscle stretching exercise are given
Main outcome variables
ankle passive dorsiflexion range of motion; gastrosoleus stiffness; pain; Quality of Life; foot and ankle kinematic
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210712051853N1
Registration date:2021-08-09, 1400/05/18
Registration timing:registered_while_recruiting
Last update:2021-08-09, 1400/05/18
Update count:0
Registration date
2021-08-09, 1400/05/18
Registrant information
Name
somaieh payehdar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4223 4896
Email address
somaieh.payehdar@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of night orthosis on foot and ankle biomechanics in children with flexible flatfoot and gastro-soleus stiffness: Based on Randomized clinical trial
Public title
Evaluation of the effect of night orthosis on foot and ankle biomechanics in children with flexible flatfoot and gastro-soleus stiffness
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 7 to 14 years
Have symptomatic flexible flatfoot and gastro-soleus stiffness
Normal BMI base on sex and age
Pain parameter score of at least 1
Exclusion criteria:
Any problems or trauma to the lower extremities
Previous Achilles tendon surgery
Abnormal ankle bony prominence
Inflammatory and / or infectious arthritis
Any internal or metabolic disorders
Neurological and musculoskeletal problems
lower limb length discrepancy
Use of any foot orthoses and the calf muscles stretching
Any injury or pathology of the foot, knee, hip and/or back
Age
From 7 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
This feature helps us to equalize the size of all blocks in cases where intermediate analyzes are required during the sampling process. In this two-group clinical trial where the size of the blocks is equal, we will have 10 subjects in the intervention group and 10 subjects in the control group. Random allocation software is used, which in addition to simple randomization, can produce Random sequences that are block-making.
For allocation concealment, which refers to the method used to execute random sequences on study participants so that the assigned group is not known before the individual is assigned. The opaque sealed envelopes in random sequences were used. In this method, each of the random sequences created is recorded on a card, and the cards are placed in the letter envelopes in order. To maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lid of the letter envelopes is glued and placed inside the box, respectively. At the beginning of the registration of the subjects, according to the order of entry of the eligible participants, one of the envelopes will be opened to determine the assigned group of the participant.
Blinding (investigator's opinion)
Single blinded
Blinding description
This is a one-way blinded study and participants will be blinded to the type of treatment that can be exercise or exercise with orthosis
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Mir Bagheri dormitory, Isfahan University dormitories,Hezarjarib St.
change of the ankle passive dorsiflexion range of motion
Timepoint
at the beginning of the study, three months later and finally two weeks after the second measurement
Method of measurement
Biodex iskinetics and goniometer
2
Description
Gastrosoleus muscle stiffness
Timepoint
At the beginning of the study, three months later and finally two weeks after the second measurement
Method of measurement
Biodex iskinetics
3
Description
gait Kinematic
Timepoint
At the beginning of the study, three months later and finally two weeks after the second measurement
Method of measurement
motion analysis
Secondary outcomes
1
Description
pain
Timepoint
At the beginning of the study, three months later and finally two weeks after the second measurement
Method of measurement
Wong-Baker FACES scale
2
Description
Quality of Life
Timepoint
At the beginning of the study, three months later and finally two weeks after the second measurement
Method of measurement
Pediatric Quality of Life Inventory
Intervention groups
1
Description
Intervention group: Night orthoses are made of similar 5 mm polypropylene in two pieces, hinged ankle joint, with an extension in the popliteal area and without a joint for the knee, So, the knee will be straight at night and the gastrocnemius muscle will be stretched effectively by dorsiflexion of the ankle joint. The hinge ankle joint of the orthosis is adjusted at the angle of the maximum amount of tolerable dorsiflexion for each subject (that it does not cause pain or discomfort). A goniometer is placed on the ankle joint to measure the dorsiflexion angle. The ankle is placed at the maximum tolerable dorsiflexion angle for maximum stretching on the gastro-soleus complex Using the orthosis elastic band. In this way, the degree of gradual increase of the dorsiflexion angle is recorded on the relevant forms by participants or their parents at night when the orthosis is worn. A hole is placed under the hindfoot to determine the full connection between the heel and the orthosis plate. Therefore, we can be ensured the complete connection of the heel in orthosis and the placement of the subtalar joint in the neutral position.
Category
Rehabilitation
2
Description
Control group: The participants will be instructed to do calf muscles eccentric stretching program for 12 weeks which included five sessions per week with each session containing three stretches performed for five sets of 30 seconds at their maximum tolerance level of stretch. To perform the calf muscles eccentric stretching program, from an upright body position and standing on one leg on the edge of the step and next to the wall (Where the subject can restore balance by hand if needed), all body weight will be placed on the forefoot and the ankle joint gone to plantar flexion, the calf muscle will be loaded by having the participant lower the heel beneath the forefoot toward the ankle plantar flexion position.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric orthopedic specialist office
Full name of responsible person
Dr. Mohammad Ali Tahririan
Street address
Arbab Street
City
Isfahan
Province
Isfehan
Postal code
3136615709
Phone
+98 31 3661 5709
Email
info@dr-tahririan.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghaiegh Haghjui Javanmard
Street address
Deputy of research and technology, Building No. 4, Hezar Jerib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3792 3060
Fax
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
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
Dr.saeed forghany
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
technical orthopedic
Street address
Hezarjarib
City
isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3792 5028
Email
saeed_forghany@yahoo.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. saeed forghany
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
technical orthopedic
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3792 5028
Email
saeed_forghany@yahoo.co.uk
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
somaieh payehdar
Position
Ph-D student
Latest degree
Master
Other areas of specialty/work
technical orthopedic
Street address
Hezarjarib
City
isfahan
Province
Isfehan
Postal code
8174643461
Phone
+98 71 4223 4896
Email
sahar.paydar@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
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
Yes - There is 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
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
The start of the access period is 6 months after the results are printed
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Only to compare documents in similar studies
From where data/document is obtainable
sahar.paydar@gmail.com
What processes are involved for a request to access data/document
The demand must be at least 6 months after the results are published