Gould 1989.

Study characteristics
Methods	Randomised controlled four‐arm parallel trial
Participants	125 normal toddlers (beginner walkers) aged 11 to 14 months Age: 11 to 14 months Gender: not stated, except “boys and girls” Table 9, p 243 – genders/groups at 5 years (27 M, 25 F) Location: University of Vermont, USA Setting: pediatrics dept Inclusion criteria: "clinically normal children... aged 11 to 14 months" Exclusion criteria: none stated Baseline characteristics: sex ratio at baseline not stated
Interventions	Group 1, N = 50 – straight last shoes Group 2, N = 25 – Group 1 shoes + long arch cookies Group 3, N = 15 – orthopaedic shoes with long counters, solid shanks, Thomas heels, 0.3 cm inside heel wedges Group 4, N = 25 – Group 3 shoes + thin longitudinal arch support
Outcomes	Baseline, 2,3, and 5 years ‐ x‐ray angles (AP talo‐1st metatarsal, lateral talo‐1st metatarsal, lateral talo‐calcaneal) ‐ biometry (pedoscope ‐ arch appearance) ‐ clinical examination ‐ use of shoes, examination of femoral, tibial, knee configuration ‐ "will be reported in detail subsequently"
Source of funding	1. Annual grant from Footwear Association 2. Shoes provided by Sabel shoes
Notes	Group 1, N = 50 acting as shod control group, across 4 years of the trial High attrition ‐ 52/125 finished the study
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	‘divided by lot into four difference footwear groups’. Insufficient information about the sequence generation process to permit judgement of low risk or high risk.
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)	Unclear risk	N/A
Blinding of outcome assessment (detection bias) ‐ objective outcomes	Unclear risk	‘A determination was made as to whether the arch was slightly or moderately improved. The records were then consulted to determine what type of footwear was worn in each case.’ It was not clear who made this determination, and if they had opportunity prior to looking at the records to know what footwear was worn in each case.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	42% of children completed the trial. Attrition was uneven between groups. Reasons for attrition were not sufficiently reported to permit judgement of low risk or high 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	Subjective and non‐validated outcome assessments. ‘A determination was made as to whether the arch was slightly or moderately improved’