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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

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History
# Registration date Revision Id
2 2024-10-24, 1403/08/03 319226
1 2022-05-08, 1401/02/18 225227
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  • Protocol summary

    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.
    this study aimed to compare the hallux valgus angle, range of motion of the first metatarsophalangeal joint, maximum 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, and one month after treatment.
    تعیین و مقایسه زاویه ی هالوکس والگوس، دامنه ی حرکتی اولین مفصل متاتارسوفالانژیال، توزیع فشار کف پا، سطح رضایت در افراد مبتلا به هالوکس والگوس در سه گروه مداخله (کفی حمایت کننده قوس طولی داخلی، کفی حمایت کننده قوس طولی داخلی دارای پد متاتارس، کفی حمایت کننده قوس طولی داخلی دارای پد متاتارس با ورزش) طی زمان‌‌های قبل از شروع درمان، یک هفته پس از درمان و یک ماه پس از درمان
    تعیین و مقایسه زاویه ی هالوکس والگوس، دامنه ی حرکتی اولین مفصل متاتارسوفالانژیال، توزیع فشار کف پا، سطح رضایت در افراد مبتلا به هالوکس والگوس در سه گروه مداخله (کفی حمایت کننده قوس طولی داخلی، کفی حمایت کننده قوس طولی داخلی دارای پد متاتارس، کفی حمایت کننده قوس طولی داخلی دارای پد متاتارس با ورزش) طی زمان‌‌های قبل از شروع درمان و یک ماه پس از درمان
    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.
    The clinical trial has three 15-parallel intervention groups (medial arch support , medial arch support with metatarsal pad, medial arch support with metatarsal pad and exercise) in a single-blind manner. Randomization for allocation to groups was done with online random number generation software.
    بعد از بررسی ده نفر، حجم نمونه تعیین شده و افراد با استفاده از نرم افزار آنلاین تولید اعداد تصادفی، در سه گروه مطالعه قرار گرفته و در سه مرحله قبل، بعد از یک هفته و یک ماه بعد از مداخله، ارزیابی انجام خواهد شد.
    کارآزمایی بالینی دارای سه گروه مداخله ۱۵ تایی موازی (کفی حمایت کننده قوس طولی داخلی، کفی حمایت کننده قوس طولی داخلی دارای پد متاتارس، کفی حمایت کننده قوس طولی داخلی دارای پد متاتارس با ورزش) به صورت یک سویه کوراست. تصادفی سازی برای تخصیص به گروه‌ها با نرم‌افزار آنلاین تولید اعداد تصادفی انجام شده است.
    The study will be performed at Iran University of Rehabilitation Sciences and will use goniometer, questionnaire and foot scan for evaluation in this study.
    The study will be conducted in Iran University of Medical Sciences and goniometer, questionnaire and foot scan will be used for evaluation in this study. The participants were unaware of the type of foot orthosis received.
    مطالعه در دانشگاه ،علوم توانبخشی ایران، انجام خواهد شد و از گونیامتر ، پرسشنامه و فوت اسکن برای ارزیابی در این مطالعه استفاده خواهد شد.
    مطالعه در دانشگاه ،علوم توانبخشی ایران، انجام خواهد شد و از گونیامتر ، پرسشنامه و فوت اسکن برای ارزیابی در این مطالعه استفاده خواهد شد. شرکت کنندگان از نوع کفی دریافتی بی اطلاع بودند.
    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
    Women 18 to 60 years with mild to moderate hallux valgus deformity according to Manchester index / normal body mass index / no history of foot surgery, no deformity other than hallux valgus in foot, no vascular disease, diabetes and rheumatoid arthritis
    زنان 18 تا 50 سال با شدت خفیف تا متوسط بدشکلی هالوکس والگوس با توجه به شاخص منچستر/با شاخص توده بدنی بین 20 تا 24.9/عدم سابقه ی جراحی در پا، عدم وجود هر گونه بدشکلی به غیر از هالوکس والگوس در پا، عدم ابتلا به بیماریهای عروقی، دیابت و روماتوئید آرتریت
    زنان 18 تا ۶۰ سال با شدت خفیف تا متوسط بدشکلی هالوکس والگوس با توجه به شاخص منچستر/با شاخص توده بدنی نرمال/عدم سابقه ی جراحی در پا، عدم وجود هر گونه بدشکلی به غیر از هالوکس والگوس در پا، عدم ابتلا به بیماریهای عروقی، دیابت و روماتوئید آرتریت
    Three intervention groups (Arch support, Arch support with metatarsal pad, Arch support with metatarsal pad with exercise)
    Three intervention groups (medial arch support , medial arch support with metatarsal pad, medial arch support with metatarsal pad and exercise)
    Satisfaction level; hallux valgus angle; range of motion of the first metatarsophalangeal joint; average pressure
    Hallux valgus angle/ range of motion of the 1st metatarsophalangeal joint /maximum pressure /satisfaction level
    سطح رضایت، زاویه ی هالوکس والگوس،دامنه ی حرکتی اولین مفصل متاتارسوفالانژیا، میانگین فشار
    سطح رضایت، زاویه ی هالوکس والگوس،دامنه ی حرکتی اولین مفصل متاتارسوفالانژیا، حداکثر فشار

  • General information

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    2022-07-25, 1401/05/03
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    2023-03-11, 1401/12/20
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    2023-03-11, 1401/12/20
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    This update is done to report the changes in the process of conducting this trial.
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    این بروزرسانی برای گزارش تغییرات به وجود آمده در روند انجام این کارآزمایی انجام می‌شود.
    Mild to moderate severity of hallux valgus deformity according to Manchester index
    Body mass index between 20 to 24.9
    Mild to moderate HV (level B and C Manchester criteria ) in both feet
    normal body mass index
    شدت خفیف تا متوسط بدشکلی هالوکس والگوس با توجه به معیار منچستر
    شاخص توده بدنی بین 20 تا 24.9
    شدت خفیف تا متوسط بدشکلی هالوکس والگوس با توجه به معیار منچستر در هر دو پا
    شاخص توده بدنی نرمال
    History of foot surgery
    Vascular disease, diabetes and rheumatoid arthritis
    Deformity other than hallux valgus in foot
    history of surgery in foot
    history of vascular diseases, diabetes and rheumatoid arthritis
    other deformities except HV in foot
    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
    Randomization tool: online random number generation software 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

  • Primary outcomes

    #1
    Before study / after one week and one month from the beginning of the intervention
    Before the intervention and one month after the intervention
    قبل از مطالعه/ بعد از یک هفته و یک ماه از شروع مداخله
    قبل از مطالعه و یک ماه از شروع مداخله
    #2
    Before study / after one week and one month from the beginning of the intervention
    Before the intervention and one month after the intervention
    قبل از مطالعه/ بعد از یک هفته و یک ماه از شروع مداخله
    قبل از مطالعه و یک ماه از شروع مداخله
    #3
    Before study / after one week and one month from the beginning of the intervention
    Before the intervention and one month after the intervention
    قبل از مطالعه/ بعد از یک هفته و یک ماه از شروع مداخله
    قبل از مطالعه و یک ماه از شروع مداخله
    #4
    Average pressure
    maximum pressure
    میانگین فشار
    حداکثر فشار
    Before study / after one week and one month from the beginning of the intervention
    Before the intervention and one month after the intervention
    قبل از مطالعه/ بعد از یک هفته و یک ماه از شروع مداخله
    قبل از مطالعه و یک ماه از شروع مداخله

  • Intervention groups

    #1
    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.
    Intervention group: Arch support made of PVC 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.
    گروه مداخله: کفی با حمایت کننده قوس طولی داخلی از جنس پلی وینیل استات برای هر فرد مناسب سازی خواهد شد و از افراد شرکت کننده خواسته می‌شود ۵ روز در هفته و ۶ ساعت در روز از کفی استفاده کنند.
    گروه مداخله: کفی با حمایت کننده قوس طولی داخلی از جنس پی وی سی برای هر فرد مناسب سازی خواهد شد و از افراد شرکت کننده خواسته می‌شود ۵ روز در هفته و ۶ ساعت در روز از کفی استفاده کنند.
    #2
    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
    Intervention group: Arch support with metatarsal pad made of PVC 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
    گروه مداخله: کفی با حمایت کننده قوس طولی داخلی و پد متاتارس از جنس پلی وینیل استات برای هر فرد مناسب سازی خواهد شد و از افراد شرکت کننده خواسته می‌شود ۵ روز در هفته و ۶ ساعت در روز از کفی استفاده کنند.
    گروه مداخله: کفی با حمایت کننده قوس طولی داخلی و پد متاتارس از جنسپی وی سی برای هر فرد مناسب سازی خواهد شد و از افراد شرکت کننده خواسته می‌شود ۵ روز در هفته و ۶ ساعت در روز از کفی استفاده کنند.
    #3
    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.
    Intervention group: Arch support with metatarsal pad made of PVC 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.

  • Recruitment centers

    #1
    Name of recruitment center - English: School of rehabilitation sciences Iran university of Medical sciences
    Name of recruitment center - Persian: دانشکده علوم اجتماعی دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Kimia Moradiani
    Full name of responsible person - Persian: کیمیا مرادیانی
    Street address - English: Valiasr St., Rajab Beigi St., Abdus Alley, Ki Kavous Alley, No. 19, Unit 4
    Street address - Persian: خیابان ولیعصر خیابان رجب بیگی کوچه عبدوس کوچه کی کاووس پلاک 19 واحد واحد ۴
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1139943915
    Phone: +98 21 6698 9321
    Fax:
    Email: Kimia.moradiani@gmail.com
    Web page address:
    Name of recruitment center - English: School of rehabilitation sciences Iran university of Medical sciences
    Name of recruitment center - Persian: دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Hasan saeedi
    Full name of responsible person - Persian: حسن سعیدی
    Street address - English: Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Madadkaran St., Mad Nazar St., Mirdamad, Mirdamad, Tehran
    Street address - Persian: تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1545913487
    Phone: +98 21 2222 7124
    Fax:
    Email: saeedi.h@iums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hossein Kiwani
    Full name of responsible person - Persian: دکتر حسین کیوانی
    Street address - English: Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, fifth floor of the headquarters
    Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران، طبقه پنجم ستاد مرکزی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۴۹۶۱۴۵۳۵
    Phone: +98 21 8670 2504
    Fax:
    Email: keyvani.h@iums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hossein Kiwani
    Full name of responsible person - Persian: دکتر حسین کیوانی
    Street address - English: Fifth floor of the headquarters, Iran University of Medical Sciences, , Hemmat Highway next to Milad Tower
    Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران، طبقه پنجم ستاد مرکزی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1449614535
    Phone: +98 21 8670 2504
    Fax:
    Email: adminsite@iums.ac.ir
    Web page address:

  • Sharing plan

    yes
    undecided
    empty
    There is no further information
    empty
    اطلاعات بیشتری وجود ندارد

Protocol summary

Study aim
this study aimed to compare the hallux valgus angle, range of motion of the first metatarsophalangeal joint, maximum 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, and one month after treatment.
Design
The clinical trial has three 15-parallel intervention groups (medial arch support , medial arch support with metatarsal pad, medial arch support with metatarsal pad and exercise) in a single-blind manner. Randomization for allocation to groups was done with online random number generation software.
Settings and conduct
The study will be conducted in Iran University of Medical Sciences and goniometer, questionnaire and foot scan will be used for evaluation in this study. The participants were unaware of the type of foot orthosis received.
Participants/Inclusion and exclusion criteria
Women 18 to 60 years with mild to moderate hallux valgus deformity according to Manchester index / normal body mass index / no history of foot surgery, no deformity other than hallux valgus in foot, no vascular disease, diabetes and rheumatoid arthritis
Intervention groups
Three intervention groups (medial arch support , medial arch support with metatarsal pad, medial arch support with metatarsal pad and exercise)
Main outcome variables
Hallux valgus angle/ range of motion of the 1st metatarsophalangeal joint /maximum pressure /satisfaction level

General information

Reason for update
This update is done to report the changes in the process of conducting this trial.
Acronym
IRCT registration information
IRCT registration number: IRCT20220413054531N1
Registration date: 2022-05-08, 1401/02/18
Registration timing: prospective

Last update: 2024-11-02, 1403/08/12
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
2022-07-25, 1401/05/03
Actual recruitment end date
2023-03-11, 1401/12/20
Trial completion date
2023-03-11, 1401/12/20
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 HV (level B and C Manchester criteria ) in both feet normal body mass index
Exclusion criteria:
history of surgery in foot history of vascular diseases, diabetes and rheumatoid arthritis other deformities except HV in foot
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 45
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization tool: online random number generation software 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
Iran University of Medical Sciences, Hemmat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
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 the intervention and one month after the intervention
Method of measurement
Goniometer

2

Description
The range of motion of the first metatarsophalangeal joint
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Goniometer

3

Description
Satisfaction level
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Foot and Ankle Outcome Score (FAOS)

4

Description
maximum pressure
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Foot scan

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Arch support made of PVC 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 PVC 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 PVC 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
Hasan saeedi
Street address
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Madadkaran St., Mad Nazar St., Mirdamad, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
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 Kiwani
Street address
Fifth floor of the headquarters, Iran University of Medical Sciences, , Hemmat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
adminsite@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)
Undecided - It is not yet known if there will be 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
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