Abstract
Background: Clubfoot is a common congenital musculoskeletal deformity which potentially leads to disability with rising incidence in Zambia. Despite effectiveness of Ponseti methods, relapse rates remain high in resource-limited settings including Zambia.
Aim: The study evaluated the effectiveness of combining ankle-foot orthosis (AFO) with Foot Abduction Brace (FAB) versus standard FAB alone in preventing relapses after Ponseti management.
Setting: University Teaching Hospital, Lusaka, Zambia.
Methods: Thirty-four patients with clubfoot were randomised to Group A (AFO+FAB, n = 17) or Group B (FAB alone, n = 17). AFO was worn during the day while the FAB was worn at sleep times either day or night. Group B only wore the FAB during sleep time. Both groups wore the devices every day for six consecutive months. Outcomes included range of motion, functional activity and relapse rates.
Results: The mean age in months was 25.41 (8.57) for the FAB group and 24.00 (7.79) for the AFO+FAB group. The AFO+FAB group experienced less decline in dorsiflexion range of motion (ROM) than the control group (β = 2.96, p = 0.007). The AFO+FAB group had a higher Ponseti functional score (β = 19.01, p < 0.001), and a lower Pirani score at the end of the study compared to FAB group (β = –0.51, p = 0.018).
Conclusion: AFO+FAB improves functional outcomes and shows promising results in managing clubfoot severity.
Contribution: This study identified that children with clubfoot may benefit from combining the two devices as it may help prevent ROM loss and improve functional activity.
Keywords: clubfoot; Ponseti; relapse; ankle-foot orthosis; foot abduction brace.
Introduction
Clubfoot, which is also known as congenital talipes equinovarus (CTEV), is a deformity that includes four components of deformities, which are: midfoot cavus, forefoot adduction, hindfoot equinus, and varus (Barrie & Varacallo 2023). It is one of the most common musculoskeletal birth disorders in the world, affecting more male children than female children (Alam et al. 2015). It consists of a collection of malformations that, if left untreated or with insufficient care, can permanently distort the foot and ankle joint (Pavone et al. 2018). The global pooled prevalence of clubfoot is estimated to be 1.18 per 1000 births (95% confidence interval [CI]: 1.00–1.36) (Smythe, Rotenberg & Lavy 2023). The rates are higher in low- and middle-income countries, particularly in the South-East Asia Region (1.80, 95% CI: 1.32–2.28) and the Africa Region (1.31, 95% CI: 0.86–1.77) (Smythe et al. 2023).
The current treatment for clubfoot is the Ponseti method, which is most widely used and is regarded as the gold standard because of its successful outcomes (Shabtai, Specht & Herzenberg 2014). Some studies have recommended Ponseti over surgery because of the risks of consequences like infection, joint stiffness and biomechanical changes that come with surgery (Bent 2023; Duffy et al. 2013; Riemen et al. 2022). This method involves the first part, called the correction phase, which involves progressive manipulation of the foot and ankle joint, which is carried out on a weekly basis, followed by Achilles tenotomy in some cases. The second part is the bracing phase, which is intended to maintain the correction that has been achieved, and the foot abduction brace (FAB) is currently the most used brace (Alves 2019; Gupta & Agarwal 2021). Although the initial treatment has a high percentage of success, the recurrence of the clubfoot deformity is still very common, resulting in neglected clubfoot and subsequent lifelong problems that add to the burden on health in developing nations (Knörr et al. 2014; Masrouha, Chu & Lehman 2021).
The bracing phase is essential for maintaining the corrections achieved in clubfoot treatment. The FAB holds the foot in abduction and dorsiflexion and must be worn consistently for approximately 4 years to prevent recurrence. However, patient compliance remains a major challenge (Zionts & Dietz 2010). A key issue is the rigidity of the FAB’s bar, which restricts active kicking motions in children, often causing irritability. Parents, unable to tolerate their child’s discomfort, frequently remove the brace, leading to inconsistent use and an increased risk of relapse (Göksan et al. 2015; Zhao et al. 2014). If left untreated, clubfoot can result in pain, stigma and lifelong disability (Ansar et al. 2018).
At the University Teaching Hospital’s Orthopaedic clinic, many children struggle with FAB adherence because of discomfort, significantly affecting treatment outcomes. Research suggests that improving brace comfort can enhance compliance and reduce relapses (Jowett, Morcuende & Ramachandran 2011; Zhao et al. 2014), yet alternative orthoses remain underexplored in this setting. To address this gap, this study aimed to evaluate the effectiveness of an ankle-foot orthosis (AFO) as an adjunct to the FAB in reducing clubfoot relapses. By assessing alternative orthoses that improve comfort and tolerance, this research aimed at optimising treatment outcomes and consequently reducing recurrence rates.
Research methods and design
Study design
This study was a single-centre, parallel randomised controlled trial which was conducted among patients with clubfoot selected from the orthopaedic clinic at the University Teaching Hospital (UTH) in Lusaka, Zambia. The study involved two groups who were required to start the intervention at the same time. Group A was subjected to both AFO and FAB (experiment) while Group B was subjected to the FAB only (control group).
Study setting
This study was conducted at the orthopaedic clinic of the UTH in Lusaka, Zambia. University Teaching Hospital, a third-level hospital located along Nationalist Road, serves as a referral centre and training facility for healthcare providers. The Consolidated Standards of Reporting Trials (CONSORT) requirements were followed in this study.
Study population and sample size
The study population comprised all male and female children receiving Ponseti clubfoot management at UTH. The inclusion criteria were children of both sexes undergoing Ponseti clubfoot management with a minimum age of 1 year and a maximum age of 3 years, with idiopathic clubfoot who had completed the correction phase and were in the maintenance phase on a night bracing regimen. They were required to be able to stand and walk independently or with minimal support. The exclusion criteria were patients with syndromic clubfoot and patients who underwent a surgical operation rather than the Ponseti method.
Sample size determination was conducted using G-Power 3.1.9.7 software. To achieve 80% power with 5% type I error rate, a minimum of 13 participants per group was required. This calculation was based on relapse rates reported by Janicki et al. (2011), where recurrence occurred in 83% of cases using AFO and 31% with FAB following correction with the Ponseti method. The sample size estimation utilised the z-test family to compare two independent proportions. To account for an anticipated 20% dropout rate, the required sample size was adjusted using the formula:
A total of 40 children with clubfoot were assessed for eligibility, of whom 6 were excluded for not meeting the inclusion criteria. Three participants dropped out during data collection, 1 from the experiment group and 2 from the control group. Intention-to-treat was used to include all the participants in the analysis (Figure 1).
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FIGURE 1: Participant enrolment and follow-up flow chart. |
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Randomisation
Thirty-four participants were randomly assigned to either the AFO+FAB or FAB group with a 1:1 ratio using simple randomisation in Stata 17, utilising computer-generated numbers. An independent researcher conducted the randomisation, and group assignments were concealed to prevent selection bias. To ensure methodological rigour, outcome assessors who are Ponseti-trained physiotherapists were blinded to group allocation, minimising assessment bias. Opaque sealed envelopes were used during the allocation. Participants’ enrolment numbers were used in place of names.
Data collection tools
Based on the study objectives, three (n = 3) assessment instruments were used to collect data. Ankle range of motion (ROM) was measured using a goniometer, assessing dorsiflexion, eversion and inversion. This ensured objective evaluation of mobility improvements over time. Goniometry involves the art and science of measuring the range of motion in each joint plane, and the goniometer is a widely used tool (Gandbhir et al. 2020). The scale has two possible ranges: from 0 degree to 180 degrees and vice versa. Studies have shown that a universal goniometer has been found to have good to excellent reliability (Gogia et al. 1987; Hanks & Myers 2023). Clubfoot severity and relapse were evaluated using the Pirani scoring system, a validated tool for assessing the severity of clubfoot deformity and identifying potential relapses. Relapse was defined as a deterioration in foot alignment necessitating additional intervention. The Pirani scoring system has three points used as its basis: 0 for no abnormality, 0.5 for moderate abnormality and 1 for severe abnormality. The Pirani scoring system has been proven to be both valid and reliable (Pirani, Hodges & Sekeramayi 2008). Functional activity was assessed using the Ponseti functional score, which evaluates a child’s ability to perform weight-bearing and ambulatory activities, providing insight into mobility improvements. It is a sum of a 100-point assessment scale, of which 30 comes from the practitioner, while 70 comes from the patient. This has been proven reliable in assessing functional outcome (Laaveg & Ponseti 1980).
Study intervention
The intervention involved incorporating an AFO alongside the standard FAB to enhance adherence and reduce clubfoot relapses. Designed to provide additional support and improve comfort, the AFO aimed to increase compliance during daytime activities, potentially lowering relapse rates. Participants were randomly assigned to two groups: Group A received standard treatment with the FAB worn only during sleep, while Group B used both the FAB (during sleep) and the AFO (throughout the day, except during bathing and passive stretching). The AFOs used were custom-made at the hospital using thermoplastic orthotic material. The parents were shown how to fit the AFO on the child and were instructed to fit it during the daytime while the child was awake and playing. The FABs were readily available at the hospital. They were fitted according to the foot size, adjusted for abduction and dorsi flexion using a bar which is designed between the two braces. Parents were instructed to wear during nap time and sleeping time. They were also educated on the importance of compliance. The intervention was implemented for a period of 6 months at the UTH by two Ponseti-trained physiotherapists, each with over 5 years of experience in clubfoot management. During reviews, monitoring was carried out by inspecting the device for indications of usage, such as worn-out straps, and parents being able to point out if the child had outgrown the size of the device.
Procedure
Data were collected at three time points: baseline, midline and endline over a 6-month period. Standardised assessment tools, including the Pirani scoring system, Ponseti functional score and the goniometer, were used to ensure consistency across all data collection stages. The Pirani score is a widely used clinical tool for assessing the severity of clubfoot, based on six deformity indicators in the midfoot and hindfoot (Pirani et al. 1999). To enhance data reliability, trained assessors conducted measurements using these instruments. Additionally, assessors remained blinded to group details to minimise assessment bias. This structured approach strengthened the rigour and validity of the study’s outcome evaluations.
Outcome measure
The study assessed three key parameters: ankle range of motion, clubfoot severity and relapse and functional activity. The co-primary endpoints were improvements in ankle ROM and functional activity from baseline. The secondary outcome was the occurrence of relapse. All parameters were measured at baseline, midline and endline to track progress over the study period.
Data analysis
Data were analysed using Stata version 17.0 for Windows. The choice of statistical tests was guided by data distribution and the nature of comparisons. Independent t tests were performed for normally distributed demographic variables, while Wilcoxon rank-sum tests were used for non-normally distributed variables when comparing groups. We used the Chi-square test to compare categorical variables; Fisher’s exact test was used when assumptions for a Chi-square test were violated.
The effect of treatment on ROM, functional activity outcome, and relapse was analysed using mixed-effect linear regression models to account for the repeated measurements within participants over time. The primary fixed effects were treatment group (treatment vs. control), time period and their interaction. The interaction term assessed whether the change in outcomes over time differed between treatment groups. All models were adjusted for potential confounding, including age, number of casts, sex of the child, bilateral involvement (bilateral vs. unilateral), affected side and tenotomy status. Model estimates were reported as regression coefficients (β) with corresponding 95% confidence interval (CI). The significance level for the statistical tests was set at 5% (p < 0.05), with results below this threshold considered statistically significant. An intentional-to-treat approach was applied to the analysis. All randomised participants were included in the groups to which they were originally assigned, regardless of whether they completed all follow-up assessments. This approach preserved the benefits of randomisation and provided an unbiased estimate of treatment effectiveness under the real-world conditions (McCoy 2017). The incomplete repeated measures were accounted for by the use of mixed-effect models (Brown 2021).
Ethical considerations
Ethical clearance to conduct this study was obtained from the University of Zambia Health Sciences Research Ethics Committee (202301270106). Certification by the National Health Research Authority (NHRA) was granted under registration number NHRAR-R 572/21/06/2023. The study was also registered with the Pan African Clinical Trial Registry (PACTR; https://pactr.samrc.ac.za) under registration number PACTR202502554262049. Institutional permission was secured before the study commenced. Informed consent was obtained from all participants’ legal guardians, with assent forms signed. Risks and potential harm were minimised by ensuring that only certified research assistants who are also Ponseti-trained physiotherapists attend to the study participants. Enrolment numbers were used in place of participants’ names. The principal investigator kept all participant records in a password-protected file.
Results
Participants’ demographic characteristics
As shown in Table 1, baseline characteristics were comparable between the two groups in terms of age (months), number of casts, affected side and tenotomy history (p > 0.05). However, a significant difference was observed in sex distribution, with a higher proportion of female children in the intervention group compared to the control group (71.4% vs. 35.0%, p = 0.037).
| TABLE 1: Baseline characteristics of study participants. |
Ankle range of motion with the use of both ankle-foot orthosis + foot abduction brace and foot abduction brace
The mixed-effects model results in Table 2 show that participants in the treatment group (AFO+FAB) had significantly higher dorsiflexion ROM than the control group (FAB) at baseline (β = 7.16, p = 0.036). The ROM declined significantly over time across all groups (β = –4.47, p < 0.001). A significant interaction between treatment and time (β = 2.96, p = 0.007) for dorsiflexion revealed that the AFO+FAB group declined less in dorsiflexion ROM than the control group. No significant treatment interactions were observed for eversion or inversion. This is visualised in Figure 2, where the predicted means from the model demonstrate the diverging trajectories between the treatment and control groups.
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FIGURE 2: Interaction effects of treatment over time on dorsiflexion, eversion and inversion. (a) Change in dorsiflexion ROM over six months by treatment group. (b) Change in eversion ROM over six months between the two treatment groups. (c) Change in inversion ROM in the two treatment groups over six months. |
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| TABLE 2: Mixed-effect linear regression showing the interaction effects of treatment over time on ankle range of motion for dorsiflexion, eversion and inversion in children with clubfoot. |
The effect of ankle-foot orthosis + foot abduction brace on the patients’ functional activity
Table 3 shows the change in patients’ functional activity from baseline to the end of the study in the two groups (AFO+FAB and the FAB only). The study shows a reduction (β = –15.62, p < 0.001) in Ponseti functional score in the control group over time (FAB only). A significant interaction between treatment and time (β = 19.01, p < 0.001) for the Ponseti functional score revealed that the AFO+FAB group had a higher functional activity score at endline compared to the control group. Figure 3 visually represents the model’s predicted means, which show how the Ponseti functional scores differ between treatment and control groups.
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FIGURE 3: Interaction effects of treatment over time on Ponseti functional score. |
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| TABLE 3: Mixed-effects regression results for the effect of treatment and time on Ponseti functional score. |
Relapses in the two intervention groups
Table 4 shows that the mean Pirani score significantly increased in the FAB intervention group at the end of the study (β = 0.76, p < 0.001). There was a significant interaction between treatment and time (β = –0.51, p = 0.018) for the Pirani score, indicating that the AFO+FAB group had a lower Pirani score at endline compared to the control group. A visual representation of how the model’s predicted Pirani means differ between treatment and control groups is shown in Figure 4.
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FIGURE 4: Interaction effects of treatment over time on Pirani score. |
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| TABLE 4: Mixed-effects regression results for the effect of treatment and time on Pirani score. |
Discussion
This study investigated the effectiveness of AFO as an adjunct to FAB in preventing clubfoot relapses. The findings demonstrated that the treatment group (AFO+FAB) had significantly higher dorsiflexion ROM than the control group (FAB alone), but no significant difference was observed in eversion and inversion ROM. However, using FAB alone resulted in a significant reduction in dorsiflexion ROM over time. Participants’ functional activity levels were initially similar in both groups, but by the end of the study, the AFO+FAB group exhibited significantly better functional outcomes. Furthermore, the FAB intervention group showed an increase in mean Pirani score, suggesting worsening clubfoot severity. In contrast, the AFO+FAB group maintained stable Pirani scores throughout the study. These findings suggest that combining AFO with FAB is more effective than FAB alone in maintaining ankle ROM and functional activity, potentially reducing the risk of relapse in children with clubfoot.
The preservation of ankle ROM in the AFO+FAB group supports previous findings that AFO use helps prevent ROM loss by enabling active movement during walking and play (Desai, Ranade & Waghela 2021; Masquijo & Allende 2023). This is particularly relevant for children with limited dorsiflexion, where an AFO may serve as a beneficial adjunct to FAB (Masquijo & Allende 2023). The decline in dorsiflexion ROM in the FAB group may be linked to poor compliance with FAB use, a well-documented issue in clubfoot management (Eidelman, Kotlarsky & Herzenberg 2019). Non-compliance with FAB has been associated with an increased risk of relapse, leading to progressive reduction in ankle dorsiflexion and decreased treatment effectiveness (Ganesan et al. 2017; Limpaphayom & Sailohit 2019; Manzoor et al. 2024). Additionally, the superior functional activity outcomes in the AFO+FAB group suggest that incorporating AFO into the treatment plan may enhance mobility and participation in daily activities. Previous research supports this, showing that AFO improves functional abilities in individuals with movement impairments (Chung, Paquette & DiAngelo 2021). Conversely, the decline in functional activity in the FAB group may also be attributed to poor compliance, a factor widely reported in a previous study (Berger et al. 2018). An important observation is that the treatment group had a higher dorsiflexion ROM at baseline, which may have influenced the magnitude of the difference observed. Although this was controlled for in the mixed-effect analysis, we cannot entirely rule out residual confounding, as the difference in starting ROM could have limited the improvement in the control group.
Compared to the control group, the AFO+FAB group showed a lower Pirani score at the end of the study, suggesting AFO+FAB is more effective in reducing clubfoot severity and relapse risk than FAB alone. This aligns with previous findings associating FAB non-compliance with an increased risk of relapse (Ganesan et al. 2017; Limpaphayom & Sailohit 2019; Manzoor et al. 2024). In contrast, lower relapse rates (21%) have been reported in other studies on FAB use alone (Manzoor et al. 2024). The significantly lower increase in mean Pirani scores in the AFO+FAB group suggests that this combination therapy may be more effective in maintaining clubfoot correction and reducing relapse likelihood (Farrar et al. 2022).
Limitations and recommendations
The study had some limitations in that although randomisation was used in allocating participants to treatment groups, significant differences were observed at baseline for some variables, such as sex, which could have introduced biases and affected the results of the study. The small number of children in each group limits the generalisability of the findings. Furthermore, treatment compliance was partially assessed. Although adherence to orthotics was occasionally noted during clinic visits (evidenced by whether the child wore the brace and its condition), no systematic methods, such as structured caregiver interviews or adherence logs, were employed to monitor consistent usage at home. This informal assessment may not fully capture variations in daily use. Future studies should consider adopting standardised and objective methods to more accurately monitor compliance, like the wear time diary (Griffiths et al. 2022).
Recommendation for further clinical trials in future should be on a large scale involving a larger sample size to improve generalisability. It may involve multiple clubfoot centres and spread across a long period in order to evaluate the sustained effects of the AFO+FAB intervention on relapse rates. Incorporation of an AFO in the maintenance phase of Ponseti management should be considered because of the potential to prevent relapses.
Conclusion
The study findings suggest that combining AFO with FAB in the management of clubfoot may enhance functional activity levels and reduce the risk of relapse compared to FAB alone. The AFO+FAB group demonstrated significantly better preservation of ankle ROM, higher levels of excellent functional activity, and a lower proportion of relapses. These findings indicate that AFO+FAB intervention is a promising approach for improving long-term clubfoot management and should be considered in clinical practice to optimise patient outcomes.
Acknowledgements
The author acknowledges Moses Lungu, Meda Chikonge and Esther Mwale.
Competing interests
The authors declare that they have no financial or personal relationships that may have inappropriately influenced them in writing this article.
Authors’ contributions
All authors approved the final article. C.M. serves as the guarantor; she conceptualised, designed, collected data, analysed and drafted the article. J.L. analysed and interpreted data. G.M. and L.A.N. designed, reviewed and supervised the study. The authors made substantial contributions to all aspects of this work and accept accountability for its entirety.
Funding information
The authors received no financial support for the research, authorship and/or publication of this article.
Data availability
The data supporting this study’s findings are available from the corresponding author, C.M., upon reasonable request.
Disclaimer
The views and opinions expressed in this article are those of the authors and are the product of professional research. It does not necessarily reflect the official policy or position of any affiliated institution, funder, agency or that of the publisher. The authors are responsible for this article’s results, findings and content.
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