Aboutorabi 2013.
Study characteristics | ||
Methods | Randomised controlled three‐arm parallel trial | |
Participants | Initially recruited N = 62, 12 excluded Study included: 30 children with flat feet, 20 healthy controls Age: average 7.76 (1.4) years Gender: 30 M, 20 F (flat foot – 18 M, 12 F; healthy – 12 M, 8 F) Location ‐ Hehran, Iran Setting: Iran University of Medical Sciences, Dept Orthopedics and Prosthetics, Faculty of Rehabilitation Sciences Inclusion criteria: flat foot and healthy children; flatfoot FPI > +6 Exclusion criteria: contracture of soft tissue, genu varum or valgum, structural congenital deformity, lower extremity fracture, neurological problems, foot or ankle surgery in past 6 months, leg length discrepancy Baseline characteristics: trial group/flat feet N = 30, 18 M:12 F, control group/non‐flat feet N = 20, 12 M:8 F |
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Interventions | 1. functional foot orthoses and regular shoe 2. medical shoes 3. barefoot |
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Outcomes | Outcomes were measured as immediate effects at baseline only. Gait parameters for the 3 interventions, i.e. 1. step length 2. step width 3. walking velocity 4. symmetry 5. centre of pressure (CoP) displacement |
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Source of funding | none | |
Notes | ‐ FPI (Foot Posture Index) of healthy group is not defined, versus the flatfoot group FPI +6 to +12. Hence, basis for comparison from baseline unclear ‐ Immediate effects only, hence, we did not include this trial in further analyses |
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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. ‘A randomised method was used for the sampling from the flat footed children who were referred for a new pair of shoes’. ‘The test order was randomised for each child to minimize learning effect.’ |
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 | Each child participates in barefoot, regular shoe, and medical shoe trials. No blinding was performed. Research staff prepared each child for barefoot, regular shoe, and medical shoe trials. No blinding was performed. |
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 | Outcomes included assessment of gait parameters. Both the participant and the researcher were considered to be outcome assessors as both could influence the result. The participants were not blinded. No mention was made of blinding of researchers involved in outcome assessment. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information to permit judgement of low risk or hHigh risk. |
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 | 5 min rest was allowed between testing conditions for each child. It was not clear if this was sufficient to eliminate a carry‐over effect. The random order of testing minimised this effect. |