The authors have declared that no competing interests exist.
Flexible pes planus (flat feet) in children is a common presenting condition in clinical practice due to concerns amongst parents and caregivers. While Foot Orthoses (FOs) are a popular intervention, their effectiveness remains unclear. Thus, the aim of this systematic review was to update the current evidence base for the effectiveness of FOs for paediatric flexible pes planus.
A systematic search of electronic databases (Cochrane, Medline, AMED, EMBASE, CINHAL, SportDiscus, Scopus and PEDro) was conducted from January 2011 to July 2017. Studies of children (0–18 years) diagnosed with flexible pes planus and intervention to be any type of Foot Orthoses (FOs) were included. This review was conducted and reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. McMaster critical review form for quantitative studies, was used to assess the methodological quality of the included studies. Given the heterogeneity of the included studies, a descriptive synthesis of the included studies was undertaken.
Out of 606 articles identified, 11 studies (three RCTs; two case-controls; five case-series and one single case study) met the inclusion criteria. A diverse range of pre-fabricated and customised FOs were utilised and effectiveness measured through a plethora of outcomes. Summarised findings from the heterogeneous evidence base indicated that FOs may have a positive impact across a range of outcomes including pain, foot posture, gait, function and structural and kinetic measures. Despite these consistent positive outcomes reported in several studies, the current evidence base lacks clarity and uniformity in terms of diagnostic criteria, interventions delivered and outcomes measured for paediatric flexible pes planus.
There continues to remain uncertainty on the effectiveness of FOs for paediatric flexible pes planus. Despite a number of methodological limitations, FOs show potential as a treatment method for children with flexible pes planus.
Pes planus, commonly known as flat feet, describes feet with lowered medial longitudinal arches [
Paediatric flexible pes planus is further categorised as symptomatic and non-symptomatic, with the later subdivided into developmental (arch develops with age) and non-developmental (arch does not develop with age) [
A range of management approaches have been proposed for paediatric flexible pes planus. Some studies have highlighted that treatment may be unnecessary, suggesting asymptomatic flatfeet do not decrease motor ability, sports performance or cause disability [
A range of non-surgical interventions have been proposed including activity modification, weight reduction, joint manipulations, serial casting, and stretching exercises [
A protocol for this systematic review was registered at the international prospective register of systematic reviews–PROSPERO (Registration # CRD42017057310).
This review was conducted and reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement [
All forms of primary research designs were considered including randomised controlled trials (RCTs), clinical control trials (CCTs), quasi-experimental, pre-post cohort studies and case studies. The eligibility criteria for the population-intervention-comparator-outcome (PICO) is outlined below.
The studies were included if the participants were children (aged 0–18 years) of either gender diagnosed with flexible pes planus, irrespective of the diagnostic criteria used. Studies were excluded if participants had any history of injury or surgery of the lower limbs or conditions affecting lower limbs including infectious or systemic conditions, muscular, neurological or osseous abnormalities.
Studies were included if the intervention was any type of foot orthoses. This may include customised or pre-fabricated orthoses with any specific characteristics and modifications.
The acceptable comparators were control (no intervention provided) or alternate interventions (shoes, physical therapy, exercise, manipulation and/or acupuncture).
Due to a variety of outcomes related to the effects of FOs on pes planus, the search was not limited to any specific outcomes. Outcomes of interest included but were not limited to pain, function, self-perception, static foot posture and kinematics of gait.
Following development of the search strategy, a review protocol was established and databases searched. All search results were pooled and duplicates were removed. Titles and abstracts were screened before analysing the full texts to determine their eligibility. Two reviewers (SD and SK) independently assessed relevant studies to be included based on the eligibility criteria. Any disagreements were resolved by discussion with a third reviewer (HB), where required.
The McMaster Critical Review Form for Quantitative Studies [
Three reviewers (SD, HB and SK) independently assessed the methodological quality of the included studies and any disputes were resolved through discussion. To determine the level of evidence of included studies, the Intervention category of the Australian National Health and Medical Research Council’s (NHMRC) evidence hierarchy was used [
Data were extracted by three independent reviewers using Microsoft Excel Spreadsheets (Microsoft Corp, Redmond Washington, USA) customised for this systematic review, any disputes were resolved through discussion. Data extracted included study and participants’ characteristics, interventions, comparators and outcomes. Additional data extracted included study’s protocol, diagnostic measures used for pes planus, measures of outcomes and adverse outcomes (
The NHMRC FORM methodology [
The initial search identified 606 studies. After pooling the searches and removing the duplicates, 542 articles were screened for titles and abstracts. Sixteen studies were reviewed in full and 11 successfully met the eligibility criteria. Five studies were excluded as they recruited adult participants (n = 3) and children with neurological conditions (n = 2). The literature selection process is outlined in
Study | NHMRC level and study design | Items on modified McMaster critical review form | Raw score and % | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 2 | 3a | 3b | 3c | 3d | 3e | 4a | 4b | 5a | 5b | 5c | 6a | 6b | 6c | 6d | 7 | |||
Asgaonkar and Kadam [ |
II; RCT | Y | Y | Y | N | Y | NA | NA | NA | NA | N | Y | Y | Y | Y | N | Y | Y | 10/17 59% |
Sinha et al. [ |
II; RCT | Y | Y | Y | N | Y | NA | N | NA | Y | N | N | Y | Y | Y | N | Y | Y | 10/17 |
Pandey et al. [ |
II; RCT | Y | Y | N | N | Y | N | Y | NA | NA | N | Y | Y | N | N | N | Y | N | 7/17 |
Pauk and Ezerskiy [ |
III-2; Case-control | Y | N | Y | N | NA | NA | Y | N | Y | Y | Y | Y | N | Y | N | 8/15 |
||
Aboutorabi et al. [ |
III-2; Case-control | Y | Y | Y | N | Y | NA | NA | N | Y | Y | Y | Y | N | Y | 9/14 |
|||
Bok et al. [ |
IV; Case series (pre+post) | Y | Y | Y | N | NA | NA | Y | Y | Y | Y | Y | Y | N | Y | Y | 11/15 |
||
Lee et al. [ |
IV; Case series (pre+post) | Y | Y | Y | N | NA | NA | NA | Y | Y | Y | Y | Y | N | Y | Y | 10/15 |
||
Bok et al. [ |
IV; Case series (post-test) | Y | Y | Y | N | Y | Y | Y | Y | Y | Y | Y | Y | N | Y | 12/14 |
|||
Jafarnezhadgero et al.(a)[ |
IV; Case series |
Y | Y | Y | Y | Y | NA | NA | Y | Y | Y | Y | Y | Y | Y | 12/14 |
|||
Jafarnezhadgero et al.(b) [ |
IV; Case Series (post-test) | Y | Y | Y | N | Y | NA | NA | Y | Y | Y | Y | Y | Y | Y | 11/14 |
|||
Su et al. [ |
IV; Single Case study | Y | N | N | N | NA | NA | Y | Y | Y | Y | N | Y | N | Y | 7/14 |
McMaster items to be scored: 1. Was the purpose stated clearly?; 2. Was relevant background literature reviewed?; 3a. Was the sample d escribed in detail?; 3b. Was sample size justified?; 3c. Were the groups randomised?; 3d. Was randomising appropriately done?; 3e. Was pes planus measure reliable (moderate or good); 4a. Were the outcome measures reliable?; 4b. Were the outcome measures valid?; 5a. Intervention was described in detail?; 5b. Contamination was avoided?; 5c. Cointervention was avoided?; 6a. Results were reported in terms of statistical significance?; 6b. Were the analysis method/s appropriate?; 6c. Clinical importance was reported?; 6d. Drop-outs were reported?; and 7. Conclusions were appropriate given study methods and results?. Y = yes, N = No, NA = not addressed and column coloured out if not applicable.
The study characteristics are summarised in
Study | N | Age (years) | Pes planus measure / diagnosis | Type of Foot Orthoses [FOs] (features) | Comparator/control | Intervention frequency |
---|---|---|---|---|---|---|
Asgaonkar and Kadam [ |
80 |
9.4 | Foot prints (instep width and plantar arch index) | Valgus insoles (4cm thickness, rubber material) | Nil | 1 year |
Sinha et al. [ |
81 |
8.2 | Symptoms (pain, fatigue and gait disturbances) | Medial Arch Orthoses (thermoplastic material, arch height dependent on patient age, foot size and alignment) | Analgesics | 2 years |
Pandey et al. [ |
200 | > 8 | Pain, Jacks test, Valgus Index, Foot Print Index and ankle ROM | Rose Schwartz insole, Thomas crooked and elongated heel with or without arch support | Foot exercise (alone/FOs) | Not addressed |
Pauk and Ezerskiy [ |
130 | 7–15 | ROM (RF, MF and FF) and ankle DF and PF | No description at all | Nil | 2 years |
Aboutorabi et al. [ |
50 | 7.87 ± 1.45 | Foot Posture Index 6 (FPI-6) | Functional FOs (thermoplastic low-density PE, identical arch height to medical shoe). Medical shoe (Custom made, leather and PE with orthoses (PE shore 55). | Barefoot | Same day |
Bok et al. [ |
39 | 10.3 ± 4.09 | RCSP ≥ 4° + 1 abnormal finding on radiographs |
Customised Rigid FOs (Blake’s inverted technique) | Nil | 2 years |
Lee et al. [ |
20 | 11.0 ± 2.0 | RCSP> 4° and Calcaneal pitch angle <20°. | Customised Rigid FOs (Blake’s inverted technique) | Nil | 3 months |
Bok et al. [ |
21 | 8–13 | RCSP ≥ 4° + 1 abnormal finding on radiographs |
Customised Rigid FOs (inverted technique, 0°, 15° and 30°)—5mm Polypropylene and high-density EVA heel posting. Top cover = mixture of low density EVA and cork. | Shoe only | Same day |
Jafarnezhadgero et al. (a)[ |
14 | 10.2 ± 1.4 | Navicular drop > 10mm, |
Pre-fab, medially posted. Peak longitudinal height of midfoot arch is 25mm. | Nil | Same day |
Jafarnezhadgero et al.(b) [ |
14 | 10.2 ± 1.4 | Navicular drop >10mm | Pre-fab, medially posted. Peak longitudinal height of midfoot arch is 25mm. | Nil | Same day |
Su et al. [ |
1 | 12 | Not addressed | Customised insole, 7mm thickness. 9 different types (3 different arch heights 27, 30 and 33mm and 3 different material hardness 30, 35 and 40°). | Barefoot | Same day |
* Bok et al. 2014 and Bok et al. 2016 –radiographic measures: Anteroposterior talocalcaneal angle (APTCA) >30 degrees; Lateral Talocalcaneal angle (LTTCA) > 45 degrees; Lateral talometatarsal angle (LTTMA) > 4 degrees; and calcaneal pitch (CP) < 20 degrees.
The number of participants ranged from one to 200 with age ranging from seven to 15 years. Overall there were more male participants than females, with weight, height and BMI being common measurements. Ethnicity of participants was not reported by any of the studies. Participants were excluded if they had neurological, muscular or systemic diseases that may affect lower limbs and if there was a history of trauma or surgery in the past. There was no consistency in terms of the diagnostic parameters for pes planus amongst the included studies with an assortment of clinical assessments and additional evaluations, such as x-rays, used for diagnosis.
While FOs were a common intervention for treating pes planus, there was great deal of variability in the parameters underpinning their use. Four studies used customised FOs [
A range of outcomes and outcome measures were utilised to evaluate the effectiveness of FOs. There was a mixture of subjective (pain [
Study | Outcome domains | Outcome Measures |
---|---|---|
Asgaonkar and Kadam [ |
Pain | VAS |
Physiological Cost Index (PCI) of walking | PCI = avg.HR-basal HR/speed | |
Gait parameters (step length, stride length, cadence and walking velocity) | Foot imprints along the walkway | |
Sinha et al. [ |
Pain (forefoot, midfoot, hindfoot) | American Orthopaedic Foot and Ankle Society (AOFAS) scores |
Foot angles |
Standardised WB radiographs | |
Pandey et al. [ |
Pain (midfoot, heel and calf) | Not addressed |
Gait changes | Shoe wear (less medial wear vs lateral) | |
Valgus index | Foot prints | |
Foot print index | ||
Pauk and Ezerskiy [ |
Gait pattern via GRF (Vertical, AP and ML) | Gait analysis on force platform |
Arch height (AH) | Navicular drop | |
Pain | Not addressed | |
Aboutorabi et al. [ |
Centre of Pressure (CoP) displacements | Force plate |
Gait parameters (step length and width, walking velocity and symmetry) | ||
Bok et al. [ |
Resting Calcaneal Stance Position–RCSP | Clinical observation |
Radiographic measures |
Anterio-Posterior and Lateral WB radiographs of each foot | |
Lee et al. [ |
Pain (site, degree and frequency) | Degree with Visual Analogue Scale and frequency as weekly |
Balance (static, dynamic and functional) | A Balance motor system (computerised posturography) | |
Bok et al. [ |
Peak pressure (kPa) | Pedar-X-inshoe pressure system (flexible insoles, 84 capacitive sensors) |
Contact area (cm2) | ||
Maximum force (N) | ||
Jafarnezhadgero et al. (a) [ |
Joint moment asymmetry | Gait Asymmetry index (1-(lesser moment/greater moment) x 100)) |
Jafarnezhadgero et al. (b) [ |
Magnitude of 3d joint moments of ankle, knee and hip. | kinetic data via gait on force plates |
Su et al. [ |
Correction of foot arch | Navicular height |
Plantar pressure distribution | F-scan for plantar pressures | |
Stress on foot tissue, joint cartilage and ligaments | CT scan |
*Foot angles by Sinha e al. 2013: Anterio-posterior (AP) and lateral talocalcaneal (TC); AP and lateral Talo-1st Metatarsal (T1MT); Lateral Calcaneal Pitch (CP); and AP Talonavicular (TN) angles.
^ Bok et al. 2014—findings on radiographs: Anteroposterior talocalcaneal angle (APTCA) >30 degrees; Lateral Talocalcaneal angle (LTTCA) > 45 degrees; Lateral talometatarsal angle (LTTMA) > 4 degrees; and calcaneal pitch (CP) < 20 degrees. Units used: kPa = kilopascal; cm2 = centimetre square; N = Newton and 3d = three dimensional.
Five studies measured pain. Three studies reported statistical significant improvement in pain (p<0.05) with the use of FOs. Of these, two measured pain using Visual Analogue Scale (VAS) [
Clinical foot posture measures used included resting calcaneal stance position (RCSP), arch height, foot print index and valgus index. RCSP was significantly improved (i.e. reduced eversion) with FOs use compared to baseline reading (p<0.05) [
Four studies measured changes in gait parameters including step length and width, stride length, cadence, walking velocity and symmetry and Ground Reaction Forces (GRFs) [
Balance measured using computerised posturography was significantly improved in static, dynamic and functional balancing ability after three months FOs use (p<0.05) [
Three studies measured pressure distribution. One study reported significant reduction in centre of pressure displacement using data from force plates [
Research by Jafarnezhadgero et al. 2017 [
Two studies measured foot angles using radiographs [
Effect of FOs use | Study | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Asgaonkar and Kadam [ |
Sinha et al. [ |
Pandey et al. [ |
Pauk and Ezerskiy [ |
Aboutorabi et al. [ |
Bok et al. [ |
Lee et al. [ |
Bok et al. [ |
Jafarnezhadgero et al.(a)[ |
Jafarnezhadgero et al.(b) [ |
Su et al. [ |
|
Pain | ↓(+) |
↓(+) |
↓(+) | ↓(+) | ↓(+) |
||||||
RCSP–eversion | ↓ |
||||||||||
Arch height | ↑(+) | ↑(+)? | |||||||||
Foot print index | ↓(+)? | ||||||||||
Valgus index | ↓(+)? | ||||||||||
PCI of walking | ↓(+) |
||||||||||
Balance | ↑(+) |
||||||||||
Step length | ↑(+) | ↑(+) | |||||||||
Step width | ↑(+) | ||||||||||
Stride length | ↑(+) | ||||||||||
Cadence | ↓(+) | ||||||||||
Walking velocity | ↑(+) | ↑(+) |
|||||||||
Medial Shoe wear | ↓(+)? | ||||||||||
Walking symmetry | ↑(+) |
||||||||||
Plantar pressure | ↓(+) |
↓(+) |
↑(-) | ||||||||
Maximum force (N) | ↓(+) |
||||||||||
Contact area (cm2) | ↑(+) |
||||||||||
Stress on tissue, joint cartilage and ligaments | ↑(-) | ||||||||||
Ankle evertor moment (Nm/Kg) | ↓(+) |
||||||||||
Knee abductor moment (Nm/Kg) | ↓(+) |
||||||||||
Hip abductor and flexor moment (Nm/Kg) | ↓(+) |
||||||||||
Hip abduction moment asymmetry | ↓(+) |
||||||||||
SP hip and knee joint moment asymmetry | ↑(-) | ||||||||||
FP subtalar joint moment asymmetry | ↑(-) | ||||||||||
Anteroposterior talocalcaneal angle | ↓(+) |
↓(+) |
|||||||||
Lateral Talocalcaneal angle | ↓(+) |
↔ | |||||||||
Lateral talo-1-metatarsal angle | ↓(+) |
↓(+) |
|||||||||
Anteroposterior talo-1-metatarsal angle | ↓(+) |
||||||||||
Calcaneal pitch | ↑(+) |
↑(+) |
|||||||||
Talonavicular angle | ↑(+) |
↑ = increase, ↓ = decrease, ↔ = no change, (+) = positive change/improvement, (-) = negative change
* = statistical significance (p<0.05), (?) = significance not reported.
The analysis of results using NHMRC FORM framework is summarised in
Component | Grade | Comments |
---|---|---|
1. Evidence base | D– |
Quantity: a total of 11 studies; |
2. Consistency | C– |
Consistent reporting of statistical significance (only two studies lacking this information); |
3. Clinical impact | D– |
While nine studies reported statistical significance, only two studies reported clinical significance; |
4. Generalisability | B– |
Population studied in the evidence base is similar to the target population; |
Grade of recommendations | D– |
Overall, most studies were low level and low methodological quality; |
As there continues to remain uncertainty on the effectiveness of FOs for paediatric flexible pes planus [
A range of diagnostic indicators for paediatric flexible pes planus were used. Most of the studies failed to identify the psychometric properties of their diagnostic methods. Common methods included RCSP [
A myriad of FOs were used with minimal justification for the choice and poor description which limits replication in clinical practice. Four studies used customised FOs, of these three used inverted or Blake’s technique [
The use of FOs for paediatric flexible pes planus identified likely improvement across several outcome domains including subjective, objective, radiographic and kinetic data. These findings offer a different perspective to that of previously published research [
As with any research, there are some limitations to this systematic review. While the systematic searching of the literature identified a modest body of evidence, there were concerns with the methodological quality. The areas of concern include sample size and sampling techniques, diagnostic criteria, development and administration of intervention and its parameters and lack of psychometrically robust outcome measures. Given that more than half of the included studies were case series/study, generalisability of the findings for these studies is limited. As flexible pes planus, can have broad ranging effects on a child, different studies focussed on different outcomes of interest. While this is to be expected, as it may reflect what occurs in clinical practice, due to the diversity of outcome measures used and heterogeneity of the interventions, a direct comparison of results between the studies was not possible. While this systematic review process was underpinned by best practice in the conduct of systematic reviews (PRISMA) [
There is an increasing body of evidence to support the widely-held view that FOs may have a positive impact across a range of outcomes including pain, foot posture, gait, function and structural and kinetic measures for paediatric flexible pes planus. However, while FOs may be considered in the management of paediatric flexible pes planus, it must be recognised that the current evidence base suffers from several identified methodological concerns and therefore implementation of recommendations should be made with caution.
A modest body of evidence has identified some support for the use of FOs in the management of paediatric flexible pes planus. However significant methodological concerns of the evidence base have also been recognized highlighting the need for future research. Future research would benefit from studies that focus on developing standardised diagnostic parameters. Similarly, future research may also improve the current evidence base by developing and implementing standardised outcome measures for pediatric flexible pes planus. Finally, methodologically sound RCTs that are conducted with larger sample sizes using power calculations and include long term follow-up would assist in identifying the sustained impact of FOs on pediatric flexible pes planus. This will ensure comparison of like with like and provide unequivocal evidence for the effectiveness of FOs for pediatric flexible pes planus.
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Thank you to University of South Australia library staff to assist in the search of literature.