Effects of combined exercises and short foot exercise with isometric hip abduction on navicular drop and postural control in individuals with pes planus
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General information
2022-09-10, 1401/06/19
2022-09-21, 1401/06/30
2022-09-1021 00:00:00
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Due to the time-consuming process of review, our initial estimated date for starting the work is before the trial registration date in the system. (The estimated date is September 10, 2022, and the review was completed on September 28, 2022). Unfortunately, neither we nor the honorable referee noticed this inadvertent error, so please correct the date to September 30 if possible. With respect
Due to the time-consuming process of review, our initial estimated date for starting the work is before the trial registration date in the system. (The estimated date is September 10, 2022, and the review was completed on September 28, 2022). Unfortunately, neither we nor the honorable referee noticed this inadvertent error, so please correct the date to September 30 if possible. With respect
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با توجه به زمانبر بودن پروسه داوری تاریخ تخمینی اولیه ما برای شروع کار قبل از تاریخ ثبت کارآزمایی در سامانه خورده شده است ، (تاریخ تخمینی ما ۱۹ شهریور ۱۴۰۱ بوده و تکمیل داوری در تاریخ ۲۸ شهریور ۱۴۰۱ صورت گرفته است). متاسفانه ما و داور محترم هیچکدام متوجه این خطای سهوی نشدیم بنابراین خواهشمند است در صورت امکان تاریخ به ۸ مهر ماه اصلاح شود. با سپاس و احترام
با توجه به زمانبر بودن پروسه داوری تاریخ تخمینی اولیه ما برای شروع کار قبل از تاریخ ثبت کارآزمایی در سامانه خورده شده است ، (تاریخ تخمینی ما ۱۹ شهریور ۱۴۰۱ بوده و تکمیل داوری در تاریخ ۲۸ شهریور ۱۴۰۱ صورت گرفته است). متاسفانه ما و داور محترم هیچکدام متوجه این خطای سهوی نشدیم بنابراین خواهشمند است در صورت امکان تاریخ به ۸ مهر ماه اصلاح شود. با سپاس و احترام
Protocol summary
Study aim
Determining the effect of combined exercises and short foot exercises with isometric hip abduction on navicular drop and postural control in patients with flat feet
Design
Clinical trial without control group, with parallel, single-blind, randomized. Randlist software will be used for randomization.
Settings and conduct
The exercises will be done in Arak University and the study groups will do their respective exercises daily for six weeks. Three sessions of supervised exercises and three sessions of home exercises will be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria include:
Age 18 to 28 years with body mass index of 18 to 25 kg per square meter, Navicular drop more than 10 mm without leg length difference of more than 1 centimeter,
No lower limb or back injury in 6 months before the study.
The absence of neurological diseases affecting balance and the dominant foot will be the right foot for all subjects.
Exclusion criteria include: Any numbness or tingling, fracture, dislocation, skin disease on the sole of the foot or vascular disease, lower limb arthritis, nerve dysfunction, lower limb injury, history of hip and ankle surgery, use of orthotics, and leg length difference. From 1centimeter .
Intervention groups
Short foot exercis group with isometric hip abduction: Subjects will perform sensory motor training of short foot simultaneously with isometric hip cont raction (with the help of Traband).
Short foot exercis group: They will perform short-foot sensory motor training.
Combination Exercise Group: They will do a series of strengthening, stretching and balance exercises.
Main outcome variables
Navicular drop; Posture control
General information
Reason for update
Due to the time-consuming process of review, our initial estimated date for starting the work is before the trial registration date in the system. (The estimated date is September 10, 2022, and the review was completed on September 28, 2022). Unfortunately, neither we nor the honorable referee noticed this inadvertent error, so please correct the date to September 30 if possible. With respect
Acronym
IRCT registration information
IRCT registration number:IRCT20220409054456N1
Registration date:2022-09-28, 1401/07/06
Registration timing:registered_while_recruiting
Last update:2023-06-06, 1402/03/16
Update count:1
Registration date
2022-09-28, 1401/07/06
Registrant information
Name
Aftab zarali
Name of organization / entity
The University of Araku
Country
Iran (Islamic Republic of)
Phone
+98 66 4266 5135
Email address
azarali2515@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-21, 1401/06/30
Expected recruitment end date
2022-12-10, 1401/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of combined exercises and short foot exercise with isometric hip abduction on navicular drop and postural control in individuals with pes planus
Public title
Effects of combined exercises and short foot exercise with isometric hip abduction on navicular drop and postural control in individuals with pes planus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index 18 to 25 kg/m2
navicular drop more than 10 mm
No injury to the lower limbs or back in the 6 months before the study
The dominant foot will be the right foot for all subjects
No leg length difference of more than 1.1 cm
Exclusion criteria:
Those who do lower extremity exercises separately
People with numbness or tingling, fractures, dislocations, plantar fasciitis, or vascular disease
Having lower limb arthritis
Neurological dysfunction
Suffering from a lower limb injury, a history of hip and ankle surgery, foot deformity or malformation
Use of orthosis
Limb length difference more than 1/1 cm
Age
From 18 years old to 28 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is parallel. The randomization unit is individual. Randlist software is used to randomly assign subjects to study groups. Randomization was done in the software as follows: At first, the number of subjects and groups is given to the software, then a code is assigned to each subject by this software. Finally a group is randomly assigned to each code by the software.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyser will not be aware of the group classification. The information of the groups will be provided to the data analyst in the form of number 1, 2 and 3 and for each participant with a code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of araku University
Street address
Basij Square, Karbala Boulevard, Arak University
City
Arak
Province
Markazi
Postal code
۳۸۴۸۱۷۷۵۸۴
Approval date
2022-03-02, 1400/12/11
Ethics committee reference number
IR.ARAKU.REC.1401.010
Health conditions studied
1
Description of health condition studied
Pes Planus
ICD-10 code
M21.4
ICD-10 code description
Flat foot [pes planus] (acquired)
Primary outcomes
1
Description
navicular drop
Timepoint
Before and after of intervention
Method of measurement
Entrance test ،Navicular drop test , Foot scan,
2
Description
Postural control
Timepoint
Before and after of intervention
Method of measurement
Foot scan
Secondary outcomes
1
Description
Knee range of motion
Timepoint
Before and after intervention
Method of measurement
Goniometer
2
Description
Static balance
Timepoint
Before and after intervention
Method of measurement
Foot scan
3
Description
Dynamic balance
Timepoint
Before and after intervention
Method of measurement
Y test ،Foot scan
4
Description
Ankle range of motion
Timepoint
Before and after intervention
Method of measurement
Goniometer
5
Description
Joint proprioception
Timepoint
Before and after intervention
Method of measurement
Goniometer
6
Description
Muscles strength of the ankle
Timepoint
Before and after intervention
Method of measurement
Dynamometer
7
Description
Muscles strength of the knee
Timepoint
Before and after intervention
Method of measurement
Dynamometer
8
Description
Gait
Timepoint
Before and after intervention
Method of measurement
Foot scan
9
Description
Quality of Life
Timepoint
Before and after intervention
Method of measurement
Questionnaire
10
Description
Pain
Timepoint
Before and after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: combined exercises
Category
Rehabilitation
2
Description
Intervention group: and short foot exercise with isometric hip abduction