Comparative study of the effect of insole and ankle-foot muscles strengthening on plantar pressure in flexible adult flatfoot
Design
Semi-experimental clinical trial, with three parallel groups, without blinding, with randomization, with a sample size of 40 people.
Settings and conduct
A sample of adults aged 18 to 28 years with flexible flat feet referred to the Faculty of Rehabilitation Sciences of Iran University of Medical Sciences.
13 people for the muscle strengthening group, 13 people for the orthosis group, and 13 people for the muscle strengthening and orthosis group will be selected.
The subject is evaluated for plantar pressure on the day of visit and 2 months later. The pressure of the sole of the foot is recorded with the RSscan force plate and the data is analyzed with the software.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Flexible flat foot
Having pain in the foot due to the symptoms of flexible flat soles
Non-entry criteria:
History of injuries, fractures and dislocations in the lower limbs
Malalignment of the lower limbs and spine
Using one of the foot orthoses for at least 3 months before the intervention
Intervention groups
First intervention group : muscle strengthening
Second intervention group: Functional foot orthosis
Third intervention group: muscle strengthening and functional foot orthosis
Main outcome variables
Plantar pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221120056547N1
Registration date:2023-03-01, 1401/12/10
Registration timing:registered_while_recruiting
Last update:2023-03-01, 1401/12/10
Update count:0
Registration date
2023-03-01, 1401/12/10
Registrant information
Name
azadeh shahini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3253 4240
Email address
shahini.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study of the Effect of Insole and Ankle-foot Muscles Strengthening on Plantar Pressure in Flexible Adult Flatfoot
Public title
Effect of Insole and Exercise in Adult Flatfoot
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Flexible flat foot based on the Foot Posture Index score (6 and above) and the formation of an arch in the state of non-weight bearing
Foot pain due to the symptoms of flexible flat foot
Ability to follow the examiner's recommendations
BMI of 19 to 25
Being 18 and older
Exclusion criteria:
Using any types of foot orthoses in at least the last 3 months before the initiation of the intervention
Malalignment of the lower limb and spine including genu-valgum and genu-varum, genu-recurvatum, leg Length discrepancy, hallux valgus and other deviations of the fingers and other abnormalities.
History of injury, fracture and dislocation in the lower limb and a problem that affects the musculoskeletal system (cerebral palsy, polio, rickets myopathy, thyroid disease, rheumatoid arthritis, diabetes, stroke)
Ulcer or skin disorder
sensory or vascular disorder
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Randomization Unit: Individual
Randomization tool: Sealed envelope
There is no concealment
Each person participating in the study will be given 3 identical envelopes in which the name of the intended intervention will be written in each envelope. One envelope with muscle strengthening intervention, one envelope with foot orthosis intervention, one envelope with muscle strengthening intervention and foot orthosis. After choosing the envelope, the content of the envelope will be seen and the person will be considered in the group. In this study, people are aware of all types of therapeutic interventions and blinding does not occur.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-10-19, 1401/07/27
Ethics committee reference number
IR.IUMS.REC.1401.255
Health conditions studied
1
Description of health condition studied
Flexible flat foot
ICD-10 code
Q66.5
ICD-10 code description
Congenital pes planus
Primary outcomes
1
Description
plantar pressure
Timepoint
Measurement of plantar pressure at the beginning of the study (before the start of the intervention) and 60 days after using orthosis, muscle strengthening exercises and orthosis and muscle strengthening exercises simultaneously.
Method of measurement
RSscan forceplate
Secondary outcomes
1
Description
Arch index
Timepoint
At the beginning of the study (before the start of the intervention) and after 60 days
Method of measurement
Calculation of the ratio of the area of the middle part of the foot to the whole foot by RSscan software
Intervention groups
1
Description
First intervention group: Muscle strengthening. Each person is evaluated individually. The foot posture index is determined for each person and a score is given to each person. The type of daily shoes of the person and the level of his activity are questioned. Necessary strengthening exercises, which include walking on the toe and the outer edge of the foot, gathering a towel with the toes, and pulling a rope, were given to the people of this group, and the number of times and how to repeat them were taught under the supervision of a physiotherapist to be performed at home. In addition, the examiner checks how to do the exercises on a daily and weekly basis. The plantar pressure of the foot is recorded with the RSscan device and the data is analyzed with the software. A person's walking speed is controlled by the sensors of the device.
Category
Treatment - Other
2
Description
Second intervention group: Foot orthosis. Foot posture index is determined for each person and each person is given a score. The type of daily shoes of the person and the level of his activity are questioned. A pair of functional foot orthosis is prepared for each subject. The orthoses are placed inside the appropriate shoes. It is explained to the person that he should avoid wearing inappropriate shoes while studying and it is better to use sports and medical shoes. The plantar pressure of the foot is recorded with the RSscan device and the data is analyzed with the software. A person's walking speed is controlled by the sensors of the device.
Category
Treatment - Other
3
Description
Third intervention group: Foot orthosis and Muscle strengthening. Foot posture index is determined for each person and each person is given a score. The type of daily shoes of the person and the level of his activity are questioned. A pair of functional foot orthosis is prepared for each subject. The orthoses are placed inside the appropriate shoes. It is explained to the person that he should avoid wearing inappropriate shoes while studying and it is better to use sports and medical shoes. Necessary strengthening exercises, which include walking on the toe and the outer edge of the foot, gathering a towel with the toes, and pulling a rope, were given to the people of this group, and the number of times and how to repeat them were taught under the supervision of a physiotherapist to be performed at home. In addition, the examiner checks how to do the exercises on a daily and weekly basis. The plantar pressure of the foot is recorded with the RSscan device and the data is analyzed with the software. A person's walking speed is controlled by the sensors of the device.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Orthotics and Prosthetics, Faculty of Rehabilitation, Iran University of Medical Scien
Full name of responsible person
Hassan saeedi
Street address
School of Rehabilitation Sciences Iran University of Medical Sciences Shahnazari St., Madar Sq., Mirdamad Blvd., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 7124
Email
Saeedi.H@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein keyvani
Street address
Iran University of Medical Sciences, 5th floor of the central headquarters, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2504
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?