Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2013-11-30
2016-05-31
Brief Summary
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Detailed Description
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Ninety recruited sample is the patient come to the foot clinic, Siriraj Hospital with the age over eighteen years old, presence of hallux valgus deformity in moderate level (without the condition of hallux rigidus), and never use hallux valgus strap or toes separator before.
The sample is given a physical assessment by physician and is asked to fill in a self-administered questionnaire which composes of general information, the foot problem information and the impact of deformity to patients function information. General information section requires the detail regarding age, genders, and the average walking hours. Foot problem information section composes of side, duration of hallux valgus and family history. Impacts of the hallux valgus deformity section includes walking problem, shoes-fitting problem, working problem, and daily activities problem, were recorded by using a numeric rating scale from 0 to 10; 0 refers as no problem and 10 refers as the worst problem. The sample then will be taken the radiograph of the feet in order to evaluate the degree of hallux valgus angle and intermetatarsal angle.
After the completion of assessment, the sample is randomly divided into 2 groups; control and experimental group by using computer program.
* Control group receives the recommendation of use the proper shoes without determination of current drug use
* Experimental group receives the custom-made mold making silicone toe separator made by certified orthotist and the recommendation of use the proper shoes without determination of current drug use
The follow up activity is on every 3rd, 6th, 9th and 12th of the study period in both groups by using questionnaire; pain score (NRS), satisfaction of using the custom-made mold making silicone toe separator (NRS) and report of complication. In the 6th and 12th month, the progress evaluation on hallux valgus and intermetatarsal angle is done by radiograph. The angle then is recorded by mean of the three values.
Descriptive statistics; mean, standard deviation or interquartile range, will be used to identify the demographic data of the participant and compliance of device usage. Analytical statistics; Unpaired t-test or Mann Whitney U test will be used for determining the average device usage time, pain score, and satisfaction of the participants after using mold making silicone toe separator.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mold making silicone toe separator
The subject in experimental group will use mold making silicone toe separator everyday
Mold making silicone toe separator
Each subject in the controlled receives the custom-made mold making silicone toe separator made by certified orthotist and the recommendation of use the proper shoes without determination of current drug use
Observation
This group will follow the physician instruction of care for the hallux valgus
Observation
The participants in this groups will be educated on how to care the hallux valgus without any intervention. The follow up will be on the 3rd, 6th, 9th and 12th month.
Interventions
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Mold making silicone toe separator
Each subject in the controlled receives the custom-made mold making silicone toe separator made by certified orthotist and the recommendation of use the proper shoes without determination of current drug use
Observation
The participants in this groups will be educated on how to care the hallux valgus without any intervention. The follow up will be on the 3rd, 6th, 9th and 12th month.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of hallux valgus deformity in moderate level, if the condition presents in both side, the one with greater angle will be selected
* Never use hallux valgus strap or toes separator before
Exclusion Criteria
* Presence of acute hallux inflammation
* Experience the use hallux valgus strap or toes separator in a past year
* Experience the allergy to silicone
18 Years
80 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Navaporn Chadchavalpanichaya
Assistance Professor
Locations
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Faculty of Medicine Siriraj Hospital
Bangkok Noi, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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silicone HV
Identifier Type: -
Identifier Source: org_study_id
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