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. 2022 Jan 26;1(1):CD006311.
doi: 10.1002/14651858.CD006311.pub4.

Foot orthoses for treating paediatric flat feet

Angela M Evans  1 , Keith Rome  2 , Matthew Carroll  3 , Fiona Hawke  4
Affiliations

Foot orthoses for treating paediatric flat feet

Angela M Evans et al. Cochrane Database Syst Rev. .

Abstract

Background: Paediatric flat feet are a common presentation in primary care; reported prevalence approximates 15%. A minority of flat feet can hurt and limit gait. There is no optimal strategy, nor consensus, for using foot orthoses (FOs) to treat paediatric flat feet.

Objectives: To assess the benefits and harms of foot orthoses for treating paediatric flat feet.

Search methods: We searched CENTRAL, MEDLINE, and Embase to 01 September 2021, and two clinical trials registers on 07 August 2020.

Selection criteria: We identified all randomised controlled trials (RCTs) of FOs as an intervention for paediatric flat feet. The outcomes included in this review were pain, function, quality of life, treatment success, and adverse events. Intended comparisons were: any FOs versus sham, any FOs versus shoes, customised FOs (CFOs) versus prefabricated FOs (PFOs).

Data collection and analysis: We followed standard methods recommended by Cochrane.

Main results: We included 16 trials with 1058 children, aged 11 months to 19 years, with flexible flat feet. Distinct flat foot presentations included asymptomatic, juvenile idiopathic arthritis (JIA), symptomatic and developmental co-ordination disorder (DCD). The trial interventions were FOs, footwear, foot and rehabilitative exercises, and neuromuscular electrical stimulation (NMES). Due to heterogeneity, we did not pool the data. Most trials had potential for selection, performance, detection, and selective reporting bias. No trial blinded participants. We present the results separately for asymptomatic (healthy children) and symptomatic (children with JIA) flat feet. The certainty of evidence was very low to low, downgraded for bias, imprecision, and indirectness. Three comparisons were evaluated across trials: CFO versus shoes; PFO versus shoes; CFO versus PFO. Asymptomatic flat feet 1. CFOs versus shoes (1 trial, 106 participants): low-quality evidence showed that CFOs result in little or no difference in the proportion without pain (10-point visual analogue scale (VAS)) at one year (risk ratio (RR) 0.85, 95% confidence interval (CI) 0.67 to 1.07); absolute decrease (11.8%, 95% CI 4.7% fewer to 15.8% more); or on withdrawals due to adverse events (RR 1.05, 95% CI 0.94 to 1.19); absolute effect (3.4% more, 95% CI 4.1% fewer to 13.1% more). 2. PFOs versus shoes (1 trial, 106 participants): low to very-low quality evidence showed that PFOs result in little or no difference in the proportion without pain (10-point VAS) at one year (RR 0.94, 95% CI 0.76 to 1.16); absolute effect (4.7% fewer, 95% CI 18.9% fewer to 12.6% more); or on withdrawals due to adverse events (RR 0.99, 95% CI 0.79 to 1.23). 3. CFOs versus PFOs (1 trial, 108 participants): low-quality evidence found no difference in the proportion without pain at one year (RR 0.93, 95% CI 0.73 to 1.18); absolute effect (7.4% fewer, 95% CI 22.2% fewer to 11.1% more); or on withdrawal due to adverse events (RR 1.00, 95% CI 0.90 to 1.12). Function and quality of life (QoL) were not assessed. Symptomatic (JIA) flat feet 1. CFOs versus shoes (1 trial, 28 participants, 3-month follow-up): very low-quality evidence showed little or no difference in pain (0 to 10 scale, 0 no pain) between groups (MD -1.5, 95% CI -2.78 to -0.22). Low-quality evidence showed improvements in function with CFOs (Foot Function Index - FFI disability, 0 to 100, 0 best function; MD -18.55, 95% CI -34.42 to -2.68), child-rated QoL (PedsQL, 0 to 100, 100 best quality; MD 12.1, 95% CI -1.6 to 25.8) and parent-rated QoL (PedsQL MD 9, 95% CI -4.1 to 22.1) and little or no difference between groups in treatment success (timed walking; MD -1.33 seconds, 95% CI -2.77 to 0.11), or withdrawals due to adverse events (RR 0.58, 95% CI 0.11 to 2.94); absolute difference (9.7% fewer, 20.5 % fewer to 44.8% more). 2. PFOs versus shoes (1 trial, 25 participants, 3-month follow-up): very low-quality evidence showed little or no difference in pain between groups (MD 0.02, 95% CI -1.94 to 1.98). Low-quality evidence showed no difference between groups in function (FFI-disability MD -4.17, 95% CI -24.4 to 16.06), child-rated QoL (PedsQL MD -3.84, 95% CI -19 to 11.33), or parent-rated QoL (PedsQL MD -0.64, 95% CI -13.22 to 11.94). 3. CFOs versus PFOs (2 trials, 87 participants): low-quality evidence showed little or no difference between groups in pain (0 to 10 scale, 0 no pain) at 3 months (MD -1.48, 95% CI -3.23 to 0.26), function (FFI-disability MD -7.28, 95% CI -15.47 to 0.92), child-rated QoL (PedsQL MD 8.6, 95% CI -3.9 to 21.2), or parent-rated QoL (PedsQL MD 2.9, 95% CI -11 to 16.8).

Authors' conclusions: Low to very low-certainty evidence shows that the effect of CFOs (high cost) or PFOs (low cost) versus shoes, and CFOs versus PFOs on pain, function and HRQoL is uncertain. This is pertinent for clinical practice, given the economic disparity between CFOs and PFOs. FOs may improve pain and function, versus shoes in children with JIA, with minimal delineation between costly CFOs and generic PFOs. This review updates that from 2010, confirming that in the absence of pain, the use of high-cost CFOs for healthy children with flexible flat feet has no supporting evidence, and draws very limited conclusions about FOs for treating paediatric flat feet. The availability of normative and prospective foot development data, dismisses most flat foot concerns, and negates continued attention to this topic. Attention should be re-directed to relevant paediatric foot conditions, which cause pain, limit function, or reduce quality of life. The agenda for researching asymptomatic flat feet in healthy children must be relegated to history, and replaced by a targeted research rationale, addressing children with indisputable foot pathology from discrete diagnoses, namely JIA, cerebral palsy, congenital talipes equino varus, trisomy 21 and Charcot Marie Tooth. Whether research resources should continue to be wasted on studying flat feet in healthy children that do not hurt, is questionable. Future updates of this review will address only relevant paediatric foot conditions.

Trial registration: ClinicalTrials.gov NCT02414087 NCT02633566 NCT03151538 NCT04104555 NCT04410926.

PubMed Disclaimer

Conflict of interest statement

KR, AE are authors of the 2010 systematic review addressing this topic.

AE declares authorship of Evidence Essentials (www.evidenceessentials.com; blog and monograph series), Board Directorship Australian Podiatry Association, Board Directorship AnglicareSA

MC: none known

KR: none known

FH: none known

Figures

1
1
Study flow diagram for the trial search
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
3
3
Forest plot of comparison: 4 CFOs versus shoes in JIA, outcome: 4.2 Function
4
4
Forest plot of comparison: 4 CFOs versus shoes in JIA, outcome: 4.3 Quality of life
5
5
Forest plot of comparison: 6 CFOs versus PFOs in JIA, outcome: 6.1 Pain
6
6
Forest plot of comparison: 6 CFOs versus PFOs in JIA, outcome: 6.3 Quality of life
1.1
1.1. Analysis
Comparison 1: Custom foot orthoses (CFOs) versus shoes for asymptomatic flat feet, Outcome 1: Proportion without pain
1.2
1.2. Analysis
Comparison 1: Custom foot orthoses (CFOs) versus shoes for asymptomatic flat feet, Outcome 2: Withdrawal due to adverse events
2.1
2.1. Analysis
Comparison 2: Prefabricated foot orthoses (PFOs) versus shoes in asymptomatic flat feet, Outcome 1: Proportion without pain
2.2
2.2. Analysis
Comparison 2: Prefabricated foot orthoses (PFOs) versus shoes in asymptomatic flat feet, Outcome 2: Withdrawal due to adverse events
3.1
3.1. Analysis
Comparison 3: CFOs versus PFOs in asymptomatic flat feet, Outcome 1: Pain
3.2
3.2. Analysis
Comparison 3: CFOs versus PFOs in asymptomatic flat feet, Outcome 2: Withdrawal due to adverse events
4.1
4.1. Analysis
Comparison 4: CFOs versus shoes in juvenile idiopathic arthritis (JIA), Outcome 1: Pain
4.2
4.2. Analysis
Comparison 4: CFOs versus shoes in juvenile idiopathic arthritis (JIA), Outcome 2: Function
4.3
4.3. Analysis
Comparison 4: CFOs versus shoes in juvenile idiopathic arthritis (JIA), Outcome 3: Quality of life
4.4
4.4. Analysis
Comparison 4: CFOs versus shoes in juvenile idiopathic arthritis (JIA), Outcome 4: Treatment success (gait parameters)
4.5
4.5. Analysis
Comparison 4: CFOs versus shoes in juvenile idiopathic arthritis (JIA), Outcome 5: Withdrawal due to adverse events
5.1
5.1. Analysis
Comparison 5: PFOs versus shoes in JIA, Outcome 1: Pain
5.2
5.2. Analysis
Comparison 5: PFOs versus shoes in JIA, Outcome 2: Function
5.3
5.3. Analysis
Comparison 5: PFOs versus shoes in JIA, Outcome 3: Quality of life
5.4
5.4. Analysis
Comparison 5: PFOs versus shoes in JIA, Outcome 4: Treatment success (Timed walking)
5.5
5.5. Analysis
Comparison 5: PFOs versus shoes in JIA, Outcome 5: Withdrawal due to adverse events
6.1
6.1. Analysis
Comparison 6: CFOs versus PFOs in JIA, Outcome 1: Pain
6.2
6.2. Analysis
Comparison 6: CFOs versus PFOs in JIA, Outcome 2: Function
6.3
6.3. Analysis
Comparison 6: CFOs versus PFOs in JIA, Outcome 3: Quality of life
6.4
6.4. Analysis
Comparison 6: CFOs versus PFOs in JIA, Outcome 4: Treatment success (timed walking)
6.5
6.5. Analysis
Comparison 6: CFOs versus PFOs in JIA, Outcome 5: Withdrawal due to adverse events
7.1
7.1. Analysis
Comparison 7: PFOs versus shoes in symptomatic flat feet, Outcome 1: Function
7.2
7.2. Analysis
Comparison 7: PFOs versus shoes in symptomatic flat feet, Outcome 2: Quality of life
9.1
9.1. Analysis
Comparison 9: Anti‐pronation taping versus sham taping, Outcome 1: Balance test (SEBT) at 4 weeks
9.2
9.2. Analysis
Comparison 9: Anti‐pronation taping versus sham taping, Outcome 2: Agility test (Illinois Agility Test) at 4 weeks
9.3
9.3. Analysis
Comparison 9: Anti‐pronation taping versus sham taping, Outcome 3: Vertical jump height (cm)
10.1
10.1. Analysis
Comparison 10: Neuromuscular electrical stimulation (NMES) versus sham NMES, Outcome 1: Navicular height (mm)
10.2
10.2. Analysis
Comparison 10: Neuromuscular electrical stimulation (NMES) versus sham NMES, Outcome 2: Staheli’s arch index (mm)
10.3
10.3. Analysis
Comparison 10: Neuromuscular electrical stimulation (NMES) versus sham NMES, Outcome 3: Calcaneal inclination angle (degrees)
10.4
10.4. Analysis
Comparison 10: Neuromuscular electrical stimulation (NMES) versus sham NMES, Outcome 4: Talus second metatarsal angle (degrees)
10.5
10.5. Analysis
Comparison 10: Neuromuscular electrical stimulation (NMES) versus sham NMES, Outcome 5: Talo‐navicular coverage angle
See this image and copyright information in PMC

Update of

Comment in

References

References to studies included in this review

Abd‐Elmonem 2021 {published data only}
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Yung 2011 {published data only}
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References to ongoing studies

ACTRN12616001082493 {unpublished data only}
    1. Effectiveness of foot orthoses in children with juvenile idiopathic arthritis: a randomised control trial. Ongoing study. not stated. Contact author for more information.
CTRI/2018/07/014989 {unpublished data only}
    1. Effect of adhesive taping and exercises on outward rotation of foot in affected children. Ongoing study. not stated. Contact author for more information.
CTRI/2019/08/020925 {published and unpublished data}
    1. CTRI/2019/08/020925.Bare foot walking effect on flat foot in school going children [Effects of bare foot walking on the flat foot in school going children:a randomised control trial]. www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=36115 (first registration 27 August 2019).
IRCT2017082235517N1 {unpublished data only}en.irct.ir/trial/26811
    1. Effects of long-term use of arch support foot orthoses on lower limb kinematics and kinetics during walking in children with flexible flat foot. Ongoing study. 4 September 2017. Contact author for more information.
ISRCTN14602568 {unpublished data only}www.isrctn.com/ISRCTN14602568
    1. Orthotics for treatment of symptomatic flat feet in children - the OSTRICH study. Ongoing study. 18 May 2020. Contact author for more information.
ISRCTN49672274 {unpublished data only}
    1. Foot disease in juvenile idiopathic arthritis: foot care trial. Ongoing study. not stated. Contact author for more information.
KCT0001717 {unpublished data only}
    1. The effects of talus control foot orthosis in children with flexible flatfoot. Ongoing study. 7 December 2015. Contact author for more information.
NCT02414087 {unpublished data only}
    1. Therapeutic effects of customized insoles on children with flatfoot. Ongoing study. not stated. Contact author for more information.
NCT02633566 {unpublished data only}
    1. Clinical trial of the effect of functional orthoses in children with flat feet. Ongoing study. not stated. Contact author for more information.
NCT03151538 {unpublished data only}
    1. Effects on pes planus exercise training mixed with play on pre-school children. Ongoing study. not stated. Contact author for more information.
NCT04104555 {unpublished data only}
    1. Orthotics for treatment of symptomatic flat feet in children - the OSTRICH study. Ongoing study. 19 September 2019. Contact author for more information.
NCT04410926 {unpublished data only}
    1. Corrective exercises with neuromuscular electrical stimulation In children with flexible flat feet. Ongoing study. 1 September 2018 to 31 December 2019. Contact author for more information.

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