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The purpose of this study is to investigate the efficay of functional plantar orthoses on flatfoot in children.
There's a considerable controversy regarding the effectiveness of plantar orthoses in the treatment of flexible flat foot, despite being the most widely used treatment. Several studies tried to investigate the correction of the deformity using plantar orthoses, but there are few studies with a control group of people, not enough to compare the effectiveness of the treatment.
A randomized, double-blind, parallel design clinical trial was conducted with two study groups. The sample consisted of 61 children, aged 3 and 4 years old, who were randomly assigned to each study group. One group (intervention group) received treatment with functional plantar orthotics, and the other group (control group) received treatment with placebo-type plantar orthotics, to use as a reference or comparison. Both groups were followed for a one-year period. Before delivering the treatment, all subjects underwent dorsoplantar radiography, repeated at the end of the treatment (after one year). Differences in the talus-calcaneus, tibionavicular and talus-first metatarsal angles were compared, pre and post-treatment of both study groups. Test analysis of covariance (ANCOVA) was performed as a statistical test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional plantar orthoses | Active Comparator | Functional plantar orthoses in polypropylene with Medial Heel Skive technique |
|
| Placebo plantar orthoses | Placebo Comparator | Plantar orthoses made in Ethil Vinyl Acetate (22º Shore) without correction of the pronation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plantar orthoses | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| X-ray measurements of the angles: talus-calcaneus, talus-navicular and talus-first metatarsal angle. | Before delivering the treatment, all subjects underwent dorsoplantar radiography, repeated at the end of the treatment (after one year). Differences in the talus-calcaneus, tibionavicular and talus-first metatarsal angles were compared, pre and post-treatment of both study groups. Test analysis of covariance (ANCOVA) was performed as a sataistical test. | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier Pascual Huerta, PhD | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35080267 | Derived | Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub4. | |
| 35029841 | Derived | Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 14;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub3. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 6, 2016 | |
| Reset | Mar 4, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 6, 2016 | Mar 4, 2016 |
| ID | Term |
|---|---|
| D005413 | Flatfoot |
| ID | Term |
|---|---|
| D000070558 | Talipes |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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| D005532 |
| Foot Deformities, Congenital |
| D038061 | Lower Extremity Deformities, Congenital |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |