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 |
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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) |
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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 |