History
# Registration date Revision Id
2 2023-05-28, 1402/03/07 267071
1 2022-09-28, 1401/07/06 241426
Changes made to previous revision
This is the first revision

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
Acronym
IRCT registration information
IRCT registration number: IRCT20220409054456N1
Registration date: 2022-09-28, 1401/07/06
Registration timing: registered_while_recruiting

Last update: 2022-09-28, 1401/07/06
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
2022-09-10, 1401/06/19
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

empty

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
Category
Rehabilitation

3

Description
Control group: Short Foot Exercis
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak University
Full name of responsible person
Zahra Raeisi
Street address
Arak University, Karbala Boulevard,Basij Square ,Arak
City
Arak
Province
Markazi
Postal code
۳۸۴۸۱۷۷۵۸۴
Phone
+98 66 4266 5135
Fax
Email
azarali2515@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University
Full name of responsible person
Hamed Safikhani
Street address
Karbala Boulevard ، Basij Square، Arak University ،
City
Arak
Province
Markazi
Postal code
۳۸۴۸۱۷۷۵۸۴
Phone
+98 86 3262 1024
Email
e-dabir@araku.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
دانشگاه اراک
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
Arak University
Full name of responsible person
Aftab Zarali
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Sport Injuries and corrective exercises
Street address
NO.16,West 16 Meters Haddadipour., West Imam Hussein
City
Borujerd
Province
Lorestan
Postal code
۳۸۴۸۱۷۷۵۸۴
Phone
+98 66 4266 5135
Fax
Email
azarali2515@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport rehabilitation and corrective movements
Street address
Karbala Boulevard,Basij Square,Arak University
City
Arak
Province
Markazi
Postal code
۳۸۴۸۱۷۷۵۸۴
Phone
+98 86 3262 1024
Email
Zـraisi13@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport rehabilitation and corrective exercises
Street address
Karbala Boulevard ,Basij Square ،Arak University
City
Arak
Province
Markazi
Postal code
۳۸۴۸۱۷۷۵۸۴
Phone
+98 86 3262 1024
Email
Z-raisi13@yahoo.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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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