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. 2022 Jan 14;2022(1):CD006311. doi: 10.1002/14651858.CD006311.pub3

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
Interventions 1. functional foot orthoses and regular shoe
2. medical shoes
3. barefoot
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
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
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.