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Effect of foot orthosis and short foot exercise on morphological characteristics of the intrinsic muscles of foot and plantar fascia in individuals with flexible flatfoot

Protocol summary

Study aim
Determining the effect of foot orthosis with short foot exercise on thickness and cross section area of the intrinsic muscles of the foot and plantar fascia angle in adults with flexible flat foot
Design
A clinical trial with a control group and an intervention group, with parallel groups, single-blind, randomized, on 30 patients, a simple randomization method with a sealed envelope is used.
Settings and conduct
This study is conducted on 30 adults with flexible flat feet in the laboratory of Shahid Beheshti College in Tehran. The researcher is not aware of the placement and grouping and the treatments performed. Patients are divided into two groups by simple randomization with sealed envelopes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adults with flexible flat feet, the presence of heel valgus, age of 18 to 40 years, foot posture index score 6 and greater than 6, body mass index in the normal range (24.9-18.5) Exclusion criteria: Rigid flatfoot, posterior tibial tendon disfunction and acquired flatfoot due to trauma, severe degree of hallux valgus, plantar fasciitis, ankle instability, knee brace, history of trauma and orthopedic surgery in the last 6 months, pregnancy, orthopedic and inflammatory diseases, history of using foot orthosis or performing foot exercises in the 6 months before the study
Intervention groups
Control group: orthosis group alone and intervention group: orthosis and exercise group together Both groups use the orthosis at least 6 hours a day for 8 weeks. In addition to the foot orthosis, the orthosis and exercise group performs short foot exercise daily, twice a day for 8 weeks.
Main outcome variables
Plantar fascia angle, abductor hallucis thickness, abductor hallucis cross-sectional area, flexor hallucis brevis thickness, flexor hallucis brevis cross-sectional area, Foot Pasture Index score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241110063658N1
Registration date: 2025-01-15, 1403/10/26
Registration timing: prospective

Last update: 2025-01-15, 1403/10/26
Update count: 0
Registration date
2025-01-15, 1403/10/26
Registrant information
Name
Parand vosoughi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7763 4633
Email address
parandvosoughi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-19, 1403/10/30
Expected recruitment end date
2025-05-21, 1404/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of foot orthosis and short foot exercise on morphological characteristics of the intrinsic muscles of foot and plantar fascia in individuals with flexible flatfoot
Public title
Insoles and exercise therapy for people with flat feet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults with flexible flatfoot The presence of heel valgus Ages 18 to 40 Foot posture index score 6 and greater than 6 Body mass index in the normal range (24.9-18.5)
Exclusion criteria:
Rigid flatfoot Posterior tibial tendon disfunction and acquired flatfoot due to trauma Severe degree of hallux valgus Plantar fasciitis Ankle instability Knee genu varum History of trauma and orthopedic surgery in the last 6 months pregnancy Orthopedic and inflammatory diseases History of using foot orthosis or performing foot exercises in the 6 months before the study
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is performed using sealed envelopes, in which a box contains 30 envelopes, 15 envelopes labeled A and 15 envelopes labeled B, and patients are asked to choose one envelope. The letter A is placed in the foot orthosis alone group and the letter B is placed in the foot orthosis and leg shortening exercise group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Ultrasound evaluations are done by a person who does not know about the groupings and a statistician who is also blind to the groupings.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Tehran, Valenjak, Daneshjoo Blvd., Arabi St.,Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-10-16, 1403/07/25
Ethics committee reference number
IR.SBMU.RETECH.REC.1403.348

Health conditions studied

1

Description of health condition studied
Flat foot
ICD-10 code
M21.4
ICD-10 code description
Flat foot [pes planus] (acquired)

Primary outcomes

1

Description
"Plantar fascia angle with the horizontal axis"
Timepoint
The beginning of the study before the intervention and 8 weeks after using the intervention
Method of measurement
Ultrasonography

2

Description
"Abductor hallucis muscle thickness"
Timepoint
The beginning of the study before the intervention and 8 weeks after using the intervention
Method of measurement
Ultrasonography

3

Description
"Abductor hallucis muscle cross section area"
Timepoint
The beginning of the study before the intervention and 8 weeks after using the intervention
Method of measurement
Ultrasonography

4

Description
"Flexor hallucis brevis muscle thickness"
Timepoint
The beginning of the study before the intervention and 8 weeks after using the intervention
Method of measurement
Ultrasonography

5

Description
"Flexor hallucis brevis muscle cross section area"
Timepoint
The beginning of the study before the intervention and 8 weeks after using the intervention
Method of measurement
Ultrasonography

Secondary outcomes

1

Description
"foot posture index score"
Timepoint
The beginning of the study before the intervention and 8 weeks after using the intervention
Method of measurement
Observation

Intervention groups

1

Description
Control group: orthosis group alone. The CNC orthosis is scanned and made in static mode through the initial scan of the foot by the Danesh Salar scanner. The full-length orthosis has an internal longitudinal arch and metatarsal pad and is made of semi-hard EVA foam. Participants in both control and intervention groups will receive the orthosis and wear it outdoors for at least 6 hours a day for 8 weeks in walking and sports shoes. The control group does not participate in any ankle and foot exercises.
Category
Rehabilitation

2

Description
Intervention group: Intervention group: group of orthosis and exercise together. The participants in the intervention group also receive the orthosis and use it for at least 6 hours a day for 8 weeks in walking and sports shoes, and in addition to the foot orthosis, they do short foot exercise without shoes, insoles and with bare feet in a standing position. It is performed on one leg next to the wall in a position where the index finger is connected to the wall to keep the balance of the body and the knee of the other leg is in flexion. in such a way that they raise the internal longitudinal arch and shorten the length of the leg in the anterior-posterior direction and move the head of the first metatarsal to the heel; Without flexing the fingers. Exercises are repeated daily, twice a day in 3 sets of 5. In each repetition, the arch is held for 5 seconds and there is a 2 minute rest between each set. After one to two weeks of training, if the participants were able to hold the contraction without falling down the navicular tuberosity, the duration of holding will increase from 5 to 10 and the number of sets will increase from 3 to 5 sets.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Biomechanics Laboratory, Faculty of Rehabilitation, Shahid Beheshti University, Tehran
Full name of responsible person
Parand Vosoughi
Street address
Tehran, Imam Hossein Square, Damavand Street, in front of Bo Ali Hospital, Shahid Beheshti Faculty of Rehabilitation Sciences, Faculty Biomechanics Laboratory
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Fax
+98 21 7759 1807
Email
info@sbmu.ac.ir
Web page address
https://rehab.sbmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Tehran, Valenjak, Daneshjoo Blvd., Arabi St., Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 23871
Fax
+98 21 2243 9907
Email
pcu@sbmu.ac.ir
Web page address
https://isid.research.ac.ir/Afshin_Zarghi
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parand Vosoughi
Position
Physiotherapy Master's student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tehran, Imam Hossein Square, Damavand Street, in front of Bo Ali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
parandvosoughi@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parand Vosoughi
Position
Physiotherapy Master's student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tehran, Imam Hossein (AS) Square, Damavand Street, in front of Bo Ali Hospital, Faculty of Rehabilitation Sciences, Shahid University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
parandvosoughi@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parand Vosoughi
Position
Physiotherapy Master's student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tehran, Imam Hossein Square, Damavand Street, in front of Bo Ali Hospital, Shahid Beheshti Faculty of Rehabilitation Sciences, Faculty Biomechanics Laboratory
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
parandvosoughi@sbmu.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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