Protocol summary
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Study aim
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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.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Three intervention groups (medial arch support , medial arch support with metatarsal pad, medial arch support with metatarsal pad and exercise)
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Main outcome variables
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Hallux valgus angle/ range of motion of the 1st metatarsophalangeal joint /maximum pressure /satisfaction level
General information
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Reason for update
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This update is done to report the changes in the process of conducting this trial.
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Acronym
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IRCT registration information
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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
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Registration date
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2022-05-08, 1401/02/18
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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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2022-08-22, 1401/05/31
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Expected recruitment end date
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2023-03-21, 1402/01/01
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Actual recruitment start date
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2022-07-25, 1401/05/03
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Actual recruitment end date
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2023-03-11, 1401/12/20
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Trial completion date
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2023-03-11, 1401/12/20
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Scientific title
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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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Public title
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The effect of medial arch support with metatarsal pad with and without exercise on Hallux valgus
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 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
Actual sample size reached:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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All participants will be given insoles and exercise, but the type of insole and exercise will not be recognizable to individuals
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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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2022-04-27, 1401/02/07
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Ethics committee reference number
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IR.IUMS.REC.1401.066
Health conditions studied
1
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Description of health condition studied
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Hallux Valgus
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ICD-10 code
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M20.1
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ICD-10 code description
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Hallux valgus (acquired)
Primary outcomes
1
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Description
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Hallux valgus angle
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Timepoint
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Before the intervention and one month after the intervention
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Method of measurement
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Goniometer
2
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Description
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The range of motion of the first metatarsophalangeal joint
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Timepoint
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Before the intervention and one month after the intervention
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Method of measurement
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Goniometer
3
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Description
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Satisfaction level
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Timepoint
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Before the intervention and one month after the intervention
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Method of measurement
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Foot and Ankle Outcome Score (FAOS)
4
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Description
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maximum pressure
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Timepoint
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Before the intervention and one month after the intervention
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Method of measurement
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Foot scan
Intervention groups
1
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Description
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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.
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Category
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Treatment - Devices
2
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Description
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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
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Category
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Treatment - Devices
3
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Description
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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.
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Category
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Treatment - Other
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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Yes
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Title of funding source
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Iran University of Medical Sciences
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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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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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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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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Plantar pressure data, Hallux valgus angle data, satisfaction level data before and after interventions It can be shared after identifying people.
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When the data will become available and for how long
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12 months after the results were published
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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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
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From where data/document is obtainable
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Contact Dr. Hassan Saeedi by email
Email: saeedi.h@iums.ac.ir
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What processes are involved for a request to access data/document
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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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Comments
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