Orthotic configuration and its effect on clubfoot: A bench research with modifications of orthotic bar length, dorsiflexion and abduction

Anil Agarwal

doi:10.1016/j.jcot.2022.101805

. 2022 Feb 12;26:101805. doi: 10.1016/j.jcot.2022.101805

Orthotic configuration and its effect on clubfoot: A bench research with modifications of orthotic bar length, dorsiflexion and abduction

Anil Agarwal ¹

PMCID: PMC8858992 PMID: 35242532

Abstract

Purpose

We determined the effect of changes in abduction orthosis for clubfoot (bar width, dorsiflexion and abduction) on ankle dorsiflexion and foot abduction.

Methods

The study included 31 children with clubfoot. An adjustable Steenbeek foot abduction orthosis permitting variations of bar width [distance between anterior superior iliac spines, shoulders and 'standard'], dorsiflexion (0, 15 and 30°) and abduction (30, 45 and 70°) was used for measurements. Ankle dorsiflexion and foot abduction were measured with and without orthosis and compared using repeated measures analysis of variance (ANOVA).

Results

Foot abduction was same as orthotic abduction in all configurations. A better ankle dorsiflexion was found with a shorter bar width, larger orthotic dorsiflexion and abduction. Contrarily, the arc increased with a wider bar. A 30° inbuilt orthotic dorsiflexion and 70° abduction produced better foot dynamics.

Conclusions

A foot abduction orthosis with modifications of shorter bar length, 30° dorsiflexion and 70° abduction may offer better soft tissue stretch and foot motion in clubfoot.

Keywords: Clubfoot, CTEV, Orthosis, Brace

Glossary and abbreviations

Arc: Ankle dorsiflexion range with knee flexed and extended
ASIS: Anterior superior iliac spine
df EXT: Ankle dorsiflexion while in orthosis with knee extended
df FLEX: Ankle dorsiflexion while in orthosis with knee flexed
Orthotic dorsiflexion: Prefabricated dorsiflexion of the shoes with respect to central bar in orthosis
Orthotic abduction: Prefabricated abduction of the shoes with respect to central bar in orthosis
SFAB: Steenbeek foot abduction brace
Existing SFAB: Steenbeek foot abduction brace used in current practice and made according to specifications as provided in the Steenbeek manual
FAO: Foot abduction orthosis
Prototype SFAB: Prefabricated SFAB dimensions of 30° dorsiflexion and abduction 70°
‘Standard’ bar width: Corresponding central bar width according to the child's foot size based on Steenbeek manual
Stretch: Combination of maximum ankle dorsiflexion and foot abduction permissible in orthosis

1. Introduction

Foot abduction orthosis (FAO) has remained a cornerstone in preventing recurrence in clubfoot.¹^,² The current design of FAO originated from almost a century old Denis Browne splint.¹^,³ In the original description of Denis Browne splint, the foreparts were twisted to an angle of 20° in the normal foot and the other foot was turned outwards as far as it was originally inwards.³ Ponseti used this brace in a modified form with shoes attached at 70° of external rotation and the bar bent approximately 10–15° dorsiflexion to keep foot plantar-flexors stretched.⁴^,⁵

Because of its shear importance for clubfoot, FAO had been a persistent focus of research. Leading investigations in orthotic designing include a surrogate biomechanical model to study different brace types and their impact on pediatric lower extremity.⁶ To address orthotic compliance issues, especially in unilateral cases, above knee unilateral designs have been proposed.⁷ Another significant development is introducing sensors in the orthosis to determine the actual wear durations.⁸^,⁹^,¹⁰ Research has also focused on mechanical assembly and inbuilt fabrications of orthosis.¹¹^,¹²^,¹³ It has been found that unique construct of FAO is essential for its functionality.¹¹ The soft tissues of clubfoot children have much better agility that current FAO can match. Thus, there remains a significant soft tissue lag despite use of existing FAO. We therefore questioned whether FAO can be improved by modifications in orthotic bar width or its inbuilt prefabrications?

To answer the above question, we made modifications to existing orthotic bar width, dorsiflexion and abduction and determined the effect of these changes on child's ankle and foot range of motion. Additionally, the study was designed to investigate an orthotic configuration which would pull out the posteromedial soft tissues ('stretch’) as well as retain the natural motion of ankle ('arc’) to a maximum possible. An adjustable model of Steenbeek foot abduction brace (SFAB) was used for the research purpose.

2. Methods

2.1. The study structure

The basic science research (bench) study was conducted at an established clubfoot clinic located in suburb of a low income country. At our institution, children up to 2 years are treated with classical Ponseti method. Following deformity correction, the children are prescribed Steenbeek foot abduction brace (SFAB) for duration of 4–5 years.¹⁴ The inclusion criteria for the current study were idiopathic clubfoot children successfully treated with Ponseti technique, wearing orthosis during the maintenance phase and having ≥10° of natural ankle dorsiflexion in knee extended position. In bilateral clubfeet, measurements were obtained on one side only (the left side).¹⁵ Patients with any pathology in lower limbs affecting hip/and knee range of motion or limb length discrepancy due to any reason were excluded. Syndromic, neurogenic and surgically intervened (other than Achilles tenotomy) clubfeet were not considered for the study. Ethical clearance for the study was obtained from the Institutional Ethical Committee (F.1/IEC/MAMC/962/02/2018/No 269 dated 30/5/2018). Prior consent from the care providers was obtained for the study. The investigational orthosis was used for research purpose only. The study had a cross-sectional design, i.e. the measurements with investigational orthosis were one time event only and the clubfoot subjects enrolled in the study continued to use the existing SFAB post measurement.

2.2. Sample size

Using Medline database, Pubmed and Google search of English literature, no study was found correlating bar width, dorsiflexion or abduction of SFAB in clubfoot patients. The three levels of effect size (Cohen's d) are '0.2 = Low’; '0.5 = Medium’, and '0.8 = Large’. Since no prior data was available to estimate effect size, the sample size was calculated assuming medium level effect size while using orthosis with a hypothetical configuration. Thirty one patients were therefore included in the above pilot study. The significance level with this sample size was above 0.025 with power 80%.

2.3. The SFAB and the adjustable model

SFAB is one of the most popular and representative FAO available for clubfoot patients (Fig. 1A and B).¹⁶ The 'standard’ bar width for respective sizes and different ages are detailed in the ‘Steenbeek brace for clubfoot’ manual.¹⁶

An adjustable model of SFAB with modularity of bar width, dorsiflexion and abduction was used for making measurements in the present study (Fig. 1C and D). For bar width, options chosen were distance between anterior superior iliac spines (ASIS), child's shoulder width and the “standard” width according to Steenbeek's manual. Distance between ASIS is a common bony parameter used in practice and also easily palpable in children and therefore chosen as the shorter orthotic width dimension. The shoulder width was measured from back between two acromion tips. Studies have shown that Indian children have narrower shoulder widths compared to ‘standard’ bar width prescribed in ‘Steenbeek brace for clubfoot’ manual.¹³

The orthosis configuration had mechanical locks for adjusting dorsiflexion at 0, 15 and 30° and abduction at 30, 45 and 70°. The ‘existing’ orthotic dorsiflexion is about 15°. Recent studies have shown that mean dorsiflexion in treated clubfeet is mean 45° up to 1 year of age and 30° up to age 5 years.¹⁷ The proposed orthotic dorsiflexion of 30° was based on above observations since we intended to test an orthotic model which can maximally stretch posteromedial tissues in clubfoot. The 0° dorsiflexion represented the dimension when orthosis lacked any inbuilt dorsiflexion. Similarly, the mean foot abduction in normal children is variably mentioned as 30–70°.¹⁸ It is also recommended that contralateral normal foot be placed at 45° abduction in unilateral clubfoot. Our experimental model considered all these factors and orthotic abduction was checked at 30, 45 and 70°.

Matching shoe pairs applicable for the enrolled age group were available which could be attached to the adjustable orthosis (Fig. 1E). While performing measurements, only one orthotic parameter (bar width/dorsiflexion/abduction) was changed at a time, the other two being kept constant e.g. when the bar width varied, the orthotic dorsiflexion and abduction remained fixed.

2.4. The measurement technique¹² (Fig. 2, Fig. 3)

Without orthosis: For measuring the natural ankle dorsiflexion, the coronal axis of leg was taken as one reference line. The other limb of goniometer was placed along the axis of 1st metatarsal. The measures were first done in hip-knee extended and later in hip-knee flexed 90°. The difference between the two measurements provided the natural dorsiflexion 'arc’ present in a child's foot. The foot abduction was next measured with thigh stabilized. The goniometer limbs were placed along the long axis of the 2nd ray and long axis of the leg.

With orthosis: For all measurements in orthosis, it was ensured that heel was in contact with the sole. For measuring dorsiflexion in orthosis, the coronal axis of leg as above was one reference line. The other limb was placed along the medial straight border of the shoe. The measurements were first obtained in hip-knee extended position. They were then repeated in hip-knee flexed position 90° with medial border of both knees just touching.

2.5. The outcome measures

An efficient FAO should maintain deformity correction by pulling out the posteromedial soft tissues ('stretch’) as well as permit ankle range of motion (‘arc’) while the child wore orthosis. Stretch for the purpose of this study was quantified as maximum passive ankle dorsiflexion (either in hip-knee extended or hip-knee flexed position) combined with foot abduction. Ankle range of motion was quantified as the dorsiflexion 'arc’ achievable while in orthosis. The natural passive ankle dorsiflexion, foot abduction and ankle range of motion without orthosis formed a comparative reference for orthotic values.

2.6. Statistical methods

Statistical relationships between measurements were calculated using online software www.socscistatistics.com. One way repeated measures analysis of variance (ANOVA) was used to compare measurements obtained with different orthotic configurations. After a preliminary analysis, it was observed that an orthotic prefabrication of 30° dorsiflexion and abduction 70° produced better stretch and arc. So a final set of measurements involved determining the best bar width with this particular orthotic configuration (hereby called prototype FAB).

3. Results

Thirty one subjects (15 unilateral) were enrolled for the study. There were 23 boys and 8 girls.

1. Naturally occuring ankle and foot range of motion

Naturally occurring ankle dorsiflexion with knee extended was 19.8 ± 10.2°. With knee flexed, the values were 26.6 ± 9.2°. The natural arc was 6.8 ± 4.4°. The foot abduction with respect to leg in horizontal plane was 54.4 ± 24.4°.

2. Effect of orthotic bar width on ankle and foot function

The orthotic abduction was transmitted as foot abduction exactly because of the central bar. Hence, there was no change in foot abduction following a change in orthotic bar width. The ankle dorsiflexion decreased following an increase in bar width (Table 1, Fig. 4). The ankle dorsiflexion was better in knee extended position. The arc however increased following an increase in bar width. As is obvious from Fig. 4, the positive values for ankle dorsiflexion and arc were possible only with bar width greater than inter ASIS distance.

Table 1.

Mean ankle dorsiflexion (degrees) and arc (degrees) with different orthotic configurations.

Constant parameter »	Configuration 1: Dorsiflexion 15°; Abduction 70°

Parameter varied: Bar width (Fig. 4)	Ankle dorsiflexion with knee extended				Arc
	ASIS	Shoulder	“Standard”	ANOVA	ASIS	Shoulder	“Standard”	ANOVA
	1.6 ± 4.0	−3.2 ± 5.6	−8.1 ± 6.3	p < 0.001	8.1 ± 5.9	14.7 ± 6.7	18.7 ± 8.1	p < 0.001
	Ankle dorsiflexion with knee flexed
	ASIS	Shoulder	“Standard”	ANOVA
	−5.8 ± 7.3	−17.9 ± 6.7	−26.8 ± 8.6	p < 0.001

Constant parameter »	Configuration 2: Bar width “standard”; Abduction 70°

Parameter varied: Orthotic dorsiflexion (Fig. 5)	Ankle dorsiflexion with knee extended				Arc
	0°	15°	30°	ANOVA	0°	15°	30°	ANOVA
	−19.7 ± 4.1	−8.1 ± 6.3	6.1 ± 7.3	p < 0.001	18.1 ± 5.4	18.7 ± 8.1	17.7 ± 6.1	p = 0.84
	Ankle dorsiflexion with knee flexed
	0°	15°	30°	ANOVA
	−37.7 ± 6.8	−26.8 ± 8.6	−11.6 ± 9.3	p < 0.001

Constant parameter »	Configuration 3: Bar width “standard”; Dorsiflexion 15°

Parameter varied: Orthotic abduction (Fig. 6)	Ankle dorsiflexion with knee extended				Arc
	30°	45°	70°	ANOVA	30°	45°	70°	ANOVA
	−12.7 ± 11.0	−9.0 ± 7.2	−8.0 ± 6.3	p = 0.07	15 ± 12.9	17.9 ± 11.1	18.7 ± 8.1	p = 0.28
	Ankle dorsiflexion with knee flexed
	30°	45°	70°	ANOVA
	−26.1 ± 11.8	−26.3 ± 10.2	−26.8 ± 8.6	p = 0.93

Constant parameter »	Configuration 4: Dorsiflexion 30; Abduction 70°

Parameter varied: Bar width (Fig. 7)	Ankle dorsiflexion with knee extended				Arch
	ASIS	Shoulder	“Standard”	ANOVA	ASIS	Shoulder	“Standard”	ANOVA
	14.4 ± 6.0	11.3 ± 6.7	6.1 ± 7.3	p < 0.001	6.3 ± 5.5	11.8 ± 5.3	17.7 ± 6.8	p < 0.001
	Ankle dorsiflexion with knee flexed
	ASIS	Shoulder	“Standard”	ANOVA
	8.4 ± 7.9	−0.5 ± 7.8	−11.6 ± 9.3	p < 0.001

Open in a new tab

ASIS-distance between the anterior superior iliac spines; Shoulder-shoulder width; “Standard”-bar width according to Steenbeek manual corresponding to shoe size.

Fig. 4 — The changes in ankle dorsiflexion and arc with respect to bar width. Better ankle dorsiflexion was available with a shorter bar width (inter ASIS distance > shoulder width). The arc on the other hand was better when bar width was longer.

3. Effect of orthotic dorsiflexion on ankle and foot function

There was again no change in foot abduction following a change in orthotic dorsiflexion. The ankle dorsiflexion however increased with larger orthotic dorsiflexion and vice versa (Table 1, Fig. 5). The arc did not change significantly with change in orthotic dorsiflexion. As is obvious from Fig. 5, the positive values for ankle dorsiflexion and arc were possible only with orthotic dorsiflexion >15°.

Fig. 5 — The changes in ankle dorsiflexion and arc with respect to orthotic dorsiflexion. Better ankle dorsiflexion was available with a larger orthotic dorsiflexion especially >15°. The arc variation was not significant.

4. Effect of orthotic abduction on ankle and foot function

The foot abduction matched the orthotic abduction. Both ankle dorsiflexion and arc decreased with lesser orthotic abduction (Table 1, Fig. 6). The changes in arc with lesser orthotic abduction were not statistically significant.

5. The prototype FAB dimensions (dorsiflexion 30° and abduction 70°, bar width?).

The existing SFAB with 'standard’ bar width, 15° inbuilt dorsiflexion and 70° abduction permitted maximum ankle dorsiflexion (with knee extended) of −8.1 ± 6.3° and an arc of 18.7 ± 8.1° which lagged behind our reference values (natural occurring ankle and foot range of motion). As is obvious from result 3, a better ankle dorsiflexion and arc was possible with an orthotic dorsiflexion >15°. Result 4 showed that the orthotic abduction is transmitted exactly as foot abduction. Taking these considerations, we fixed the orthotic dorsiflexion to 30° and abduction at 70° and tested three different bar widths (distance between ASIS, shoulders and the “Standard”) (Table 1; configuration 4) for the prototype FAB. With inter ASIS width, maximum stretch (ankle dorsiflexion in extension) was approximately 14° and arc 6° (Fig. 7). With bar equal to the shoulder width, slightly less stretch of approximately 11° but greater arc of 12° was obtained. With “Standard” bar width, a stretch of approximately 6° and arc of 18° was produced. None however equaled/exceeded the reference values (Result 1).

Fig. 7 — The *prototype* orthosis with prefabrication of dorsiflexion 30° and abduction 70°: A compromise between stretch and arc was available at bar width equal to child's shoulder width.

4. Discussion

Our study tackled an important aspect of bar width and inbuilt prefabrication of FAO; the impact of their alteration on foot motion clinically and possibility to employ further modifications. The foot abduction was same as orthotic abduction in all configurations. A better ankle dorsiflexion was found with a shorter bar width, larger orthotic dorsiflexion and abduction. Contrarily, the arc increased with a longer bar. The study inferred that a SFAB prototype with 30° inbuilt orthotic dorsiflexion and 70° abduction produced better foot dynamics. The values however still lagged behind the natural range of motion references present in a clubfoot child. Although, it was difficult to comment on perfect bar width for the prototype FAB, the shoulder width produced a compromise between stretch and ankle range of motion (Fig. 7) and it could be one of the width setting.

Despite the current available evidence on usefulness of FAO in clubfoot, its' construct peculiarity is a potential problem for both children and their parents. This is clearly reflected by a quest of new orthosis being researched.¹⁹^,²⁰^,²¹^,²²^,²³ Changes may be required in design and prefabrication of orthosis since the current configuration of FAO does not achieve the desired foot mechanics.¹¹ The 30° dorsiflexion and 70 abduction orthotic construct as postulated in our study may be investigated further for effectiveness in clinical practice.

The recurrences in idiopathic clubfoot are hypothesized to occur due to retracting fibrosis of the musculotendinous units and ligaments of the posterior and medial ankle.² As the bar connected FAO places these soft tissues under stretch, tissues undergo the phenomenon of 'stress relaxation’. The contractility of the soft tissue involved gradually reduces with time, reaches a static equilibrium and recurrences therefore decrease subsequently. The difference in orthotic achieved and natural ankle and foot movements could explain some of the recurrences occurring even in well complaint clubfoot children although we may add here that a short snapshot cross-over study design as ours is incapable of fully explaining a time-dependent change such as recurrence.

Our study had other limitations which we like to point out. The population chosen and the specificity of the brace used may prevent generalization of overall results. It is also reiterated that experimental measurements may not imply clinically significant improvement in orthotic function. It is first of its kind research to assess the impact of change in bar width, orthotic dorsiflexion and abduction on foot motion clinically. Since the bilateral feet may be correlated, the measurements were made only on single foot to enhance statistical strength and interpretation.¹⁵ The technique used in the study permitted changes in foot motion while in orthosis to be recorded instantly. It therefore, quantitatively measured the effect of orthotic configuration on actual basis rather than comfort perceptions/assumptions. An evidence supported orthotic mechanics can ensure the best FAO for the clubfoot pathology, improve tolerance and in long term, prevent recurrence. The FAO could possibly be improved further in its function by modifications in its mechanical built. Clearly, more thought and multicentre research is highly desirable to enhance our knowledge in orthotic science for clubfoot.

5. Conclusions

A foot abduction orthosis with modifications of shorter bar length, 30° dorsiflexion and 70° abduction may offer better soft tissue stretch and foot motion in clubfoot. Further research is suggested on orthotics used in clubfoot.

Funding

There is no funding source.

Declaration of competing interest

The authors declare that they have no conflict of interest.

Acknowledgements

The orthosis metallic model and different shoe sizes for this study were provided by CURE India International Trust.

References

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[bib2] 2.Zhao D., Liu J., Zhao L., Wu Z. Relapse of clubfoot after treatment with the Ponseti method and the function of the foot abduction orthosis. Clin Orthop Surg. 2014;6:245–252. doi: 10.4055/cios.2014.6.3.245. [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib3] 3.Browne D. Congenital talipes equino-varus. Br Med J. 1931;2:696–699. doi: 10.1136/bmj.2.3693.696. [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib4] 4.Ponseti I.V., Smoley E.N. The classic: congenital club foot: the results of treatment. 1963. Clin Orthop Relat Res. 2009;467:1133–1145. doi: 10.1007/s11999-009-0720-2. [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib5] 5.Laaveg S.J., Ponseti I.V. Long-term results of treatment of congenital club foot. J Bone Joint Surg Am. 1980;62:23–31. [PubMed] [Google Scholar]

[bib6] 6.Dimeo A.J., Sr., Lalush D.S., Grant E., Morcuende J.A. Development of a surrogate biomodel for the investigation of clubfoot bracing. J Pediatr Orthop. 2012;32:e47–e52. doi: 10.1097/BPO.0b013e3182571656. [DOI] [PubMed] [Google Scholar]

[bib7] 7.Hegazy M., El Barbary H., Hammoud M., et al. The foot external rotation above-knee (FERAK) brace versus the Denis Browne brace for management of idiopathic clubfoot following Ponseti casting: a randomized controlled trial. Int Orthop. 2022;46:313–319. doi: 10.1007/s00264-021-05107-0. [DOI] [PubMed] [Google Scholar]

[bib8] 8.Aroojis A., Pandey T., Dusa A., Krishnan A.G., Ghyar R., Ravi B. Development of a functional prototype of a SMART (Sensor-integrated for Monitoring and Remote Tracking) foot abduction brace for clubfoot treatment: a pre-clinical evaluation. Int Orthop. 2021;45:2401–2410. doi: 10.1007/s00264-021-05042-0. [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib9] 9.Richards B.S., Faulks S., Felton K., Karacz C.M. Objective measurement of brace wear in successfully Ponseti-treated clubfeet: pattern of decreasing use in the first 2 years. J Am Acad Orthop Surg. 2020;28:383–387. doi: 10.5435/JAAOS-D-19-00163. [DOI] [PubMed] [Google Scholar]

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Orthotic configuration and its effect on clubfoot: A bench research with modifications of orthotic bar length, dorsiflexion and abduction

Anil Agarwal