Kanatli 2016.
Study characteristics | ||
Methods | Randomised controlled two‐arm parallel trial | |
Participants | 45 children, gender (33 boys, 12 girls) ‐ with moderate flexible flatfoot Age: mean age 39.5 months (17 to 72 months) Location: Ankara, Turkey Setting: Gazi University School of Medicine Inclusion criteria: moderate flexible flatfoot (Volpe classification ‐ Jack's test, standing heel position) Exclusion criteria: rigid flatfoot, neuromuscular disorders, genetic disease associated with collagen abnormalities Baseline characteristics: sample sex ratio 33 M: 12 F, not stated/group |
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Interventions | 1. orthopaedic shoes, N = 21 2. control group, N = 24 |
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Outcomes | Baseline and at follow up, i.e. 34.6 (10.9) months (range 24 to 57 months) ‐ Joint laxity (Wynne‐Davis method) ‐ Arch Index (Staheli method) ‐ x‐ray angles (lateral and AP talo‐1st metatarsal, lateral talo‐horizontal, lateral calcaneal pitch, lateral and AP talo‐calcaneal) |
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Source of funding | not stated | |
Notes | Orthopaedic shoes had internal ‘orthosis’ and Thomas heels | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Systematic, non‐random approach. ‘Patients were randomised and separated in two groups. Randomization was made by weekly basis. Patients that fulfilled the inclusion criteria during even number weeks consisted group 1 and in odd number weeks consisted group 2.’ |
Allocation concealment (selection bias) | High risk | Inexplicably unconcealed procedure: allocated depending on week odd or even week at enrolment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Children were not blinded. Children received orthopaedic shoes or no intervention. Personnel fitted the orthopaedic shoes or no intervention. |
Blinding of outcome assessment (detection bias) ‐ self‐reported outcomes (e.g., pain, function) | Unclear risk | N/A |
Blinding of outcome assessment (detection bias) ‐ objective outcomes | Unclear risk | It is not clear who assessed the outcomes and if this person was aware of group allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All enrolled children completed the study. |
Selective reporting (reporting bias) | High risk | Arch index scores were not reported for any time point. |
Other bias | Unclear risk | It was not clear how the orthopaedic shoes in this study were funded. |