Ahn 2017.
Study characteristics | ||
Methods | Randomised controlled two‐arm parallel trial | |
Participants | 40 children with flexible flat feet Age: average 10 (4.5) years Gender: 24 M, 16 F Location: Daejeon, Korea Setting: Department of Pediatric Rehabilitation at Chung Nam National University Hospital Inclusion criteria: flexible flatfoot defined as > 4° valgus RCSP, one abnormal x‐ray finding i.e. > 30° AP talo‐calcaneal angle, > 45° lateral talo‐calcaneal angles, > 4° lateral talo‐metatarsal angles, < 10° calcaneal pitch Exclusion criteria: rigid flatfoot, of any cause Baseline characteristics: matched except for age ‐ RFO 10.14 (4.99) years, TCFO 9.59 (4.24) years |
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Interventions | 1. rigid foot orthoses (N = 20) 2. talus control foot orthoses (N = 20) |
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Outcomes | ‐ RCSP ‐ x‐rays, 4 angles: AP talo‐calcaneal angle, lateral talo‐calcaneal angles, lateral talo‐metatarsal angles, calcaneal pitch Both measures were assessed at baseline and after 12 months |
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Source of funding | none reported | |
Notes | no mention of pain, or gait parameters | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information about the sequence generation process to permit judgement of low risk or high risk. ‘Forty children were randomly prescribed a foot orthosis: 20 a RFO and 20 a TCFO’ |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement of low risk or high risk. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded Personnel were not blinded |
Blinding of outcome assessment (detection bias) ‐ self‐reported outcomes (e.g., pain, function) | High risk | N/A |
Blinding of outcome assessment (detection bias) ‐ objective outcomes | Unclear risk | It was not clear if the person who measured resting calcaneal stance position or radiographs was blinded. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The number of children who completed the study, or for whom outcome data were presented was not reported. |
Selective reporting (reporting bias) | Unclear risk | No reference to study protocol. Insufficient information to permit judgement of low risk or high risk. |
Other bias | Unclear risk | Funding source for orthoses was not stated. |