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

Jafarnezhadgero 2018.

Study characteristics
Methods Randomised controlled two‐arm parallel trial
Participants 30 healthy boys, with flexible flat feet
Age: 8 to 12 years
Gender: all boys
Location: not clear ‐ boys 'recruited from orthopaedic specialists in local community' (p 4)
Setting: not clear, ethics approval and trial registry within Iran (p 4)
Inclusion criteria: boys who volunteered, flat feet assessed using navicular drop, arch height index, RCSP
Exclusion criteria: history of bone fractures, signs of functional lower limb instability, ligament injury, reconstruction of ligaments, neuromuscular dysfunction, dysfunction of lower limb muscles, leg length differences larger than 1 cm, and a history of lower extremity trauma or surgery.
Baseline characteristics: all were right foot dominant, no significant baseline differences between groups for examined variables
Interventions Treatment group (N = 15): medial arch support foot orthoses (custom made medial arch support foot orthoses), CFOs
Control group (N = 15): flat 2‐mm thick insoles (sham)
Outcomes Gait kinematics and ground reaction forces (kinetic) ‐ joint vectors, moments, and ground reaction forces
Source of funding Deutsche Forschungsgemeinschaft (DFG), and Open Access Publishing Fund of University of Potsdam, Germany.
Notes All participants issued with same footwear (New Balance 759)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Says only ‘The block randomization method was used to allocate study participants into experimental groups.’
Allocation concealment (selection bias) Unclear risk Says only; ‘Another naïve examiner controlled the allocation of each participant and was responsible for delivering the treatment to both groups.’
Not enough information to determine risk.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Sham orthoses used
Blinding of outcome assessment (detection bias) ‐ self‐reported outcomes (e.g., pain, function) High risk Due to nature of intervention
Blinding of outcome assessment (detection bias) ‐ objective outcomes Low risk Examiners blinded for all outcomes
Incomplete outcome data (attrition bias)
All outcomes Low risk No missing data
Selective reporting (reporting bias) Unclear risk Iranian Registry of Clinical Trials (IRCT2017082235517N1; URL: www.irct.ir/user/trial/26811/ view) ‐ unable to access the online trial registry.
Other bias Low risk none apparent