ArticleBMC pediatrics2025
Effectiveness of a digital-based gradual exercise training program for preventing relapse in congenital clubfoot: a protocol for a randomized controlled clinical trial.
Article in BMC pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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9 authors.
Funding
Abstract
backgroundCongenital clubfoot (CCF) is characterized by foot deformity. The Ponseti method achieves anatomical correction through casting and orthotics, but there is a high probability of further recurrence before skeletal maturity. It is challenging to maintain long-term correction and prevent relapse. Patients may benefit from physiotherapy interventions designed to enhance ankle function and overall mobility. This protocol proposed here aims to evaluate a digital-based gradual exercise training program for reducing relapse rates, improving joint flexibility, and enhancing quality of life among children with CCF and their family caregivers, in comparison to those who receive only the Ponseti method.
methodsThis study will be a single-blind, randomized controlled trial. A total of 100 patients will be allocated to the intervention group or the control group. The intervention group will receive a digital-based gradual exercise training program in addition to the Ponseti method, while the control group will receive only the Ponseti method. The exercise training program will include a caregiver reinforcement training session and a gradual personalized exercise training program. All exercises are managed digitally through the online management platform. Outcomes will be measured by assessors at the initial visit, 6 months after the intervention, and again when the child reaches 5 years of age. The therapist will continuously adjust the treatment plan based on the child’s functional status during each clinic follow-up visit. Children with CCF will be evaluated using the relapse rate as the primary outcome. The secondary outcome measures will include the Evertor muscle clinical activity (EMCA), Dimeglio scores, Pirani scores, ankle joint range of motion measurements, anthropometric measurements, the Short Form 36 Health Survey(SF-36) scores, Zarit Caregiver Burden Scale (ZCBS) score, Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) score, and Pirani Böhm Sinclair (PBS) score. DISCUSSION: This study aims to evaluate a digital-based rehabilitation approach for children with CCF to prevent relapse, improve joint flexibility, and enhance family compliance with treatment. It is expected that the intervention group may show lower relapse rates compared with the control group, indicating that the program could be effective in supporting both children with CCF and their families. If confirmed, these results may support the integration of a gradual exercise training program into standard CCF care and highlight its potential role in improving long-term outcomes.
trial registrationChiCTR2400087557, registered July 30, 2024, on the Chinese Clinical Trial Registry.
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