Whitford 2007.
Study characteristics | ||
Methods | Randomised clinical three‐arm parallel trial | |
Participants | 672 children responded to advertisements Recruited 178 with flexible flat feet Age: 7 to 11 years Gender: male 53.4%, female 46.6% Inclusion: bilateral flexible flat feet, as indicated by RCSP > 5° everted, Navicular drop 10 mm or greater Exclusion: unilateral flexible excessive foot pronation, history of lower limb surgery, any serious medical pathology, such as cancer, known neuromuscular motor co‐ordination condition, prior or recent foot orthoses use, intellectual or learning difficulty, or any chromosomal abnormality Location: Adelaide, South Australia Setting: outpatients Baseline characteristics: lower laxity score in CFO group 17.0 versus PFO 26.2, and shoes 30.6 |
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Interventions | Gp 1: CFOs Gp 2: PFOs Gp 3: no orthoses (control) |
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Outcomes | Assessment at baseline, 3 months, 12 months Outcome included in the trial 1. motor proficiency 2. pain ‐ proportion with pain in subgroup that had pain (post hoc analysis) 3. exercise efficiency 4. self‐perception profile Outcome included in this review is proportion without pain at 12 months |
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Source of funding | not stated (NHMRC) | |
Notes | Most children did not have pain at baseline, pain analysed as subgroup Secondary outcomes measured included ligamentous laxity, tight calf muscles, and body mass index |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization was undertaken using computer generated lists of equally sized groups’. |
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, and parents were not blinded.’ ‘Prescribing podiatrists… were not blinded’. |
Blinding of outcome assessment (detection bias) ‐ self‐reported outcomes (e.g., pain, function) | High risk | Motor proficiency, pain, Self Perception Profile ‐ outcomes are subjective or influenced by participants, and participants were not blinded |
Blinding of outcome assessment (detection bias) ‐ objective outcomes | Low risk | exercise efficiency ‐ ‘As in‐shoe orthoses are concealed within the child’s shoes when worn, raters of outcome measures were blinded to the orthotic status of the child.’ |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rate and reasons similar between groups |
Selective reporting (reporting bias) | Unclear risk | No reference to study protocol. The measurement of pain was done using VAS as a continuous measure, but reported only as a dichotomous outcome. |
Other bias | Unclear risk | Funding source not stated |