The effect of medial arch support with metatarsal pad with and without exercise on the degree of deviation, satisfaction and pressure distribution in people with mild to moderate hallux valgus
Determining and comparing the hallux valgus angle, range of motion of the first metatarsophalangeal joint, Distribution of plantar pressure, level of satisfaction in people with hallux valgus in three intervention groups (Arch support, Arch support with metatarsal pad, Arch support with metatarsal pad with exercise) during the periods before treatment, one week after treatment and one month after treatment.
Design
After examining ten people, the sample size was determined and individuals were divided into three study groups using online software for generating random numbers, and in three stages before, one week and one month after the intervention, evaluation will be performed.
Settings and conduct
The study will be performed at Iran University of Rehabilitation Sciences and will use goniometer, questionnaire and foot scan for evaluation in this study.
Participants/Inclusion and exclusion criteria
Women 18 to 50 years with mild to moderate hallux valgus deformity according to Manchester index / with body mass index between 20 to 24.9 / no history of foot surgery, no deformity other than hallux valgus in the leg, no To vascular disease, diabetes and rheumatoid arthritis
Intervention groups
Three intervention groups (Arch support, Arch support with metatarsal pad, Arch support with metatarsal pad with exercise)
Main outcome variables
Satisfaction level; hallux valgus angle; range of motion of the first metatarsophalangeal joint; average pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220413054531N1
Registration date:2022-05-08, 1401/02/18
Registration timing:prospective
Last update:2022-05-08, 1401/02/18
Update count:1
Registration date
2022-05-08, 1401/02/18
Registrant information
Name
Kimia Moradiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6698 9321
Email address
kimia.moradiani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-22, 1401/05/31
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of medial arch support with metatarsal pad with and without exercise on the degree of deviation, satisfaction and pressure distribution in people with mild to moderate hallux valgus
Public title
The effect of medial arch support with metatarsal pad with and without exercise on Hallux valgus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate severity of hallux valgus deformity according to Manchester index
Body mass index between 20 to 24.9
Exclusion criteria:
History of foot surgery
Vascular disease, diabetes and rheumatoid arthritis
Deformity other than hallux valgus in foot
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization tool: Online software for generating random numbers
Using the numbers that are randomly generated in the software, each participant receives a specific number and randomly in three groups: insole with arch support, arch support with metatarsal pad and arch support with metatarsal pad with exercise
Blinding (investigator's opinion)
Single blinded
Blinding description
All participants will be given insoles and exercise, but the type of insole and exercise will not be recognizable to individuals
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Valiasr St., Rajab Beigi St., Abdus Alley, Ki Kavous Alley, No. 19, Unit 4
City
Tehran
Province
Tehran
Postal code
1139943915
Approval date
2022-04-27, 1401/02/07
Ethics committee reference number
IR.IUMS.REC.1401.066
Health conditions studied
1
Description of health condition studied
Hallux Valgus
ICD-10 code
M20.1
ICD-10 code description
Hallux valgus (acquired)
Primary outcomes
1
Description
Hallux valgus angle
Timepoint
Before study / after one week and one month from the beginning of the intervention
Method of measurement
Goniometer
2
Description
The range of motion of the first metatarsophalangeal joint
Timepoint
Before study / after one week and one month from the beginning of the intervention
Method of measurement
Goniometer
3
Description
Satisfaction level
Timepoint
Before study / after one week and one month from the beginning of the intervention
Method of measurement
Foot and Ankle Outcome Score (FAOS)
4
Description
Average pressure
Timepoint
Before study / after one week and one month from the beginning of the intervention
Method of measurement
Foot scan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Arch support made of EVA will be adapted for each person and the participants will be asked to use the insole 5 days a week and 6 hours a day.
Category
Treatment - Devices
2
Description
Intervention group: Arch support with metatarsal pad made of EVA will be adapted for each person and the participants will be asked to use the insole 5 days a week and 6 hours a day
Category
Treatment - Devices
3
Description
Intervention group: Arch support with metatarsal pad made of EVA will be adapted for each person and the participants will be asked to use the insole 5 days a week and 6 hours a day In this group, in addition to insoles, special hallux valgus exercises and abductor and flexor muscles of the big toe will be taught to people and people will be asked to do exercises twice a day and ten times each time.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of rehabilitation sciences Iran university of Medical sciences
Full name of responsible person
Kimia Moradiani
Street address
Valiasr St., Rajab Beigi St., Abdus Alley, Ki Kavous Alley, No. 19, Unit 4
City
Tehran
Province
Tehran
Postal code
1139943915
Phone
+98 21 6698 9321
Email
Kimia.moradiani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Kiwani
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, fifth floor of the headquarters
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?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Hasan Saeedi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics And prosthetics
Street address
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Maddakaran St., Shah Nazari St., Mirdamad, Madar Square
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
saeedi.h@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hasan Saeedi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics And prosthetics
Street address
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Maddakaran St., Shah Nazari St., Mirdamad, Madar Square
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
saeedi.h@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hasan Saeedi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics And prosthetics
Street address
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Maddakaran St., Shah Nazari St., Mirdamad, Madar Square
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
saeedi.h@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Plantar pressure data, Hallux valgus angle data, satisfaction level data before and after interventions It can be shared after identifying people.
When the data will become available and for how long
12 months after the results were published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Scientific research and treatment of patients
The use of data is possible only by mentioning the name and organizational affiliation of the executor and colleagues of the published project and article
From where data/document is obtainable
Contact Dr. Hassan Saeedi by email
Email: saeedi.h@iums.ac.ir
What processes are involved for a request to access data/document
If the data is used in scientific and therapeutic activities, the information will be provided to the people as soon as possible