Protocol summary

Study aim
Investigate effect of 12 weeks systematic and functional corrective exercises on the balance, strength, postural control, ankel proprioception and posture of students with pronation distortion syndrome
Design
The controlled clinical trials, With crossover groups, A blind strain, Randomized
Settings and conduct
Experimental group, performed systematic and functional corrective exercises for 12 weeks and control group performed the routine exercise.
Participants/Inclusion and exclusion criteria
Entry requirements:diagnosis of pronation distortion syndrome in both feet, based on the corrective exercise specialist’s opinion; detection of flexible flat feet without pain, evaluated by heel rise test, navicular drop more than 10 mm, and grade 2 flat feet; age range of 10-16 years; having normal vision or corrected vision using spectacles or contact lenses; absence of other acute or chronic diseases preventing exercise; physician’s agreement with corrective exercises; no history of injury or surgery on the knee; no history of severe injury or surgery on the ankle, knee, thighs, hip, or back completing the informed consent form and individual health questionnaire. Exclusion criteria: inner ear disorders; problems affecting balance in the nervous system; atrial fibrillation or uncorrectable refractive error; history of lower limb injury, fracture, or surgery; abnormal range of lower limb movements; serious orthopedic disorders, such as having rigid flat feet (structural); presence of pain or emergence of pain during the study; not completing the pretest or posttest; inconsistent participation in exercise sessions.
Intervention groups
Experimental group, performed systematic and functional corrective exercises for 12 weeks (3 sessions per week for one hour), and control group performed the routine exercise.
Main outcome variables
Balance; Strength; Postural control; Ankel proprioception; and Posture

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190824044597N1
Registration date: 2019-09-11, 1398/06/20
Registration timing: retrospective

Last update: 2019-09-11, 1398/06/20
Update count: 0
Registration date
2019-09-11, 1398/06/20
Registrant information
Name
َAli Golchini
Name of organization / entity
University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3793 2195
Email address
ali.golchini@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-04, 1397/07/12
Expected recruitment end date
2018-12-08, 1397/09/17
Actual recruitment start date
2018-10-06, 1397/07/14
Actual recruitment end date
2018-12-13, 1397/09/22
Trial completion date
2019-04-18, 1398/01/29
Scientific title
Effect of 12 weeks systematic and functional corrective exercises on the balance, strength, postural control, ankel proprioception and posture of students with pronation distortion syndrome
Public title
The effect of corrective exercises on pronation distortion syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of pronation distortion syndrome in both feet, Based on the corrective exercise specialist’s opinion;detection of flexible flat feet without pain, evaluated by heel rise test, navicular drop more than 10 mm, and grade 2 flat feet, Age range of 10-16 years, Having normal vision or corrected vision using spectacles or contact lenses, Absence of other acute or chronic diseases preventing exercise, Physician’s agreement with corrective exercises; no history of injury or surgery on the knee; No history of severe injury or surgery on the ankle, knee, thighs, hip, or back Completing the informed consent form and individual health questionnaire.
Exclusion criteria:
Inner ear disorders; Problems affecting balance in the nervous system; Atrial fibrillation or uncorrectable refractive error; History of lower limb injury, fracture, or surgery; Abnormal range of lower limb movements; Serious orthopedic disorders, such as having rigid flat feet (structural); Presence of pain or emergence of pain during the study; Not completing the pretest or posttest; Inconsistent participation in exercise sessions (absence from two consecutive sessions or three sessions during the course).
Age
From 10 years old to 16 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population of this study included all male students aged 10-16 years with pronation distortion syndrome who referred to schools and screening about 1836 people and the coherent evaluation of the subjects by correction specialist instructors in 3 areas of Kermanshah was formed. The sample consisted of 30 people who were selected by random cluster sampling based on inclusion and exclusion criteria from male students (1836) aged 10-16 years . But they were randomly divided into two groups of 15 control (routine activity) and experimental (systematic and functional corrective exercises).
Blinding (investigator's opinion)
Single blinded
Blinding description
The control and experimental groups did not know which independent variables they were running.
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the University of Isfahan
Street address
Shiraz Gate
City
Isfahan
Province
Isfehan
Postal code
8174673441
Approval date
2018-01-20, 1396/10/30
Ethics committee reference number
IR.UI.REC.1396.037

Health conditions studied

1

Description of health condition studied
Lower body pronation deviation syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Balance
Timepoint
Before and after 12 weeks of corrective exercises
Method of measurement
Estabilometr device, Lak Lak and Star Excursion Test

2

Description
Strength
Timepoint
Before and after 12 weeks of corrective exercises
Method of measurement
Dynamometer digital

3

Description
Postural control
Timepoint
Before and after 12 weeks of corrective exercises
Method of measurement
Force plate

4

Description
Ankel proprioception
Timepoint
Before and after 12 weeks of corrective exercises
Method of measurement
Electrogoniometer

5

Description
Posture
Timepoint
Before and after 12 weeks of corrective exercises
Method of measurement
Navikular drop and Staheli Index, Goniometer,Coliseum and Landing Error Scoring System, and Flexible Ruler

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Performed systematic and functional corrective exercises for 12 weeks (3 sessions per week for one hour).
Category
Rehabilitation

2

Description
Control group: Performed the routine exercise.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Mahdi Sports Hall
Full name of responsible person
Ali Golchini
Street address
Monaze Street
City
Kremanshah
Province
Kermanshah
Postal code
683879
Phone
+98 83 3721 1199
Fax
+98 83 3721 1199
Email
Ali.golchini@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Isfahan
Full name of responsible person
Dr. Rasool Raknizadeh
Street address
Shiraz Gate
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 1793 2128
Email
Ali.golchini@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University of Isfahan
Proportion provided by this source
20
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 Isfahan
Full name of responsible person
َAli Golchini
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physical education and sports science (trend: sport injuries, corrective exercises)
Street address
Shiraz Gate, Isfahan University, Department of Physical Education, Department of Pathology & Corrective Exercises
City
Isfahan
Province
Isfehan
Postal code
6715438675
Phone
+98 31 3793 2195
Fax
Email
Ali.golchini@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
َAli Golchini
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physical education and sports science (trend: sport injuries, corrective exercises)
Street address
Shiraz Gate, Isfahan University, Department of Physical Education, Department of Pathology & Corrective Exercises
City
Isfahan
Province
Isfehan
Postal code
6715438675
Phone
+98 31 3793 2195
Fax
Email
Ali.golchini@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
َAli Golchini
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physical education and sports science (trend: sport injuries, corrective exercises)
Street address
Shiraz Gate, Isfahan University, Department of Physical Education, Department of Pathology & Corrective Exercises
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2195
Fax
Email
Ali.golchini@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on the main consequences
When the data will become available and for how long
5 months after printing the results
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
Statistical analysis of data
From where data/document is obtainable
Ali Golchini Email: Ali.golchini@gmail.com Phone: 09183589577
What processes are involved for a request to access data/document
Information will be sent by email or phone call within 2 weeks.
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