Asgaonkar 2012.

Study characteristics
Methods	Randomised controlled two‐arm parallel trial
Participants	80 children with flat feet, aged 5 to 15 years, in Mumbai, India 1. treatment group N = 45 2. age‐sex matched control group N = 35 Age: 5 to 15 years Gender: not stated, but groups 'age and sex matched' (p 91) Location: primary and secondary schools Setting: Mumbai, India Inclusion criteria: flat feet ‐ from footprint measures (Bleck arch index > 1.15) Exclusion criteria: fixed foot deformity, surgeries for foot deformities, pain injury that had required non‐weight bearing, systemic problems Baseline characteristics: matched, but uneven group sizes
Interventions	1. valgus insole, rubber material of average thickness 4 cm (N = 45) 2. no treatment (N = 35)
Outcomes	Outcome measures at baseline and 12 months 1. Pain ‐ VAS 2. PCI (physical cost index) ‐ average HR and speed for 100 m walk 3. Gait parameters ‐ step length, stride length, cadence, walking velocity
Source of funding	none reported
Notes	‐ 20/80 dropouts in 12‐month trial, most from treatment group ‐ pain used VAS – some children were only 5 years old ‐ valgus insole vague; unsure re: footwear used in either group (presume ‘usual’, but not stated)
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. "Out of the total 80 students, age, and sex, matched two groups were made at random; control group consisting of 35 students and experimental group consisting of 45 students."
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	No blinding, and the outcome was likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) ‐ self‐reported outcomes (e.g., pain, function)	High risk	No mention was made of blinding of researchers involved in outcome assessment.
Blinding of outcome assessment (detection bias) ‐ objective outcomes	High risk	No mention was made of blinding of researchers involved in outcome assessment.
Incomplete outcome data (attrition bias) All outcomes	High risk	Imbalance in number of dropouts per group. n = 45 in the experimental group, 9 participants withdrew from the study and an additional 6 participants left the school. n = 35 in the control group, it appears 5 participants left the school and none withdrew from the study. Reasons for dropouts from the experimental group were not provided, but are likely related to the intervention.
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	No funding source reported