Protocol summary
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Study aim
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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
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Design
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Clinical trial without control group, with parallel, single-blind, randomized. Randlist software will be used for randomization.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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 .
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Intervention groups
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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.
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Main outcome variables
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Navicular drop; Posture control
General information
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Reason for update
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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
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Acronym
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IRCT registration information
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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
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Registration date
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2022-09-28, 1401/07/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-09-21, 1401/06/30
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Expected recruitment end date
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2022-12-10, 1401/09/19
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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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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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 28 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-03-02, 1400/12/11
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Ethics committee reference number
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IR.ARAKU.REC.1401.010
Health conditions studied
1
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Description of health condition studied
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Pes Planus
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ICD-10 code
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M21.4
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ICD-10 code description
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Flat foot [pes planus] (acquired)
Primary outcomes
1
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Description
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navicular drop
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Timepoint
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Before and after of intervention
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Method of measurement
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Entrance test ،Navicular drop test , Foot scan,
2
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Description
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Postural control
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Timepoint
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Before and after of intervention
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Method of measurement
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Foot scan
Secondary outcomes
1
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Description
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Knee range of motion
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Timepoint
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Before and after intervention
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Method of measurement
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Goniometer
2
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Description
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Static balance
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Timepoint
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Before and after intervention
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Method of measurement
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Foot scan
3
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Description
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Dynamic balance
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Timepoint
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Before and after intervention
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Method of measurement
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Y test ،Foot scan
4
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Description
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Ankle range of motion
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Timepoint
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Before and after intervention
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Method of measurement
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Goniometer
5
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Description
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Joint proprioception
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Timepoint
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Before and after intervention
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Method of measurement
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Goniometer
6
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Description
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Muscles strength of the ankle
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Timepoint
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Before and after intervention
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Method of measurement
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Dynamometer
7
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Description
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Muscles strength of the knee
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Timepoint
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Before and after intervention
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Method of measurement
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Dynamometer
8
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Description
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Gait
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Timepoint
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Before and after intervention
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Method of measurement
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Foot scan
9
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Description
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Quality of Life
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Timepoint
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Before and after intervention
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Method of measurement
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Questionnaire
10
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Description
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Pain
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Timepoint
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Before and after intervention
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group: combined exercises
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Category
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Rehabilitation
2
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Description
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Intervention group: and short foot exercise with isometric hip abduction
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Category
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Rehabilitation
3
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Description
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Control group: Short Foot Exercis
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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دانشگاه اراک
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable