The Effect of Customized 3D Printed Insoles on Physical Activity Level, Balance, and Physical Performance in Patients with Pes Planus: A Randomized, Placebo Controlled, Double-Blinded Study

Year 2024, Volume: 16 Issue: 1, 67 - 76, 14.03.2024

Enes Öztürk Ramazan Kurul

https://doi.org/10.18521/ktd.1353248

Abstract

Objective: The aim of this study was to investigate the effects of individually designed insoles on physical activity level, balance and functional performance in patients with pes planus.
Methods: 38 participants were divided into 2 groups as 3D printed (n=20) and placebo(n=18). In the 3D printed group, medial longitudinal arch support, medial wedge of the foot, medial heel wedge and transverse arch support were given to the insoles according to the needs of the participants. The placebo group received placebo insoles. Range of motion, muscle strength, static and dynamic balance, physical and physical activity levels were measured at baseline, and eight weeks later (clinicaltrials.gov ID: NCT05306886).
Results: Muscle strengths of the plantar flexion and eversion increased after the use of insoles in the 3D printed and placebo groups (p<0.05). There was no improvement in static balance in both groups (p>0.05), but there were significant improvements in dynamic balance in both groups (p<0.05). Gait speed improved in both groups (p<0,05). There was no significant difference in the explosive power of both groups (p>0.05). The shuttle run test improved significantly in the placebo group (p<0.05), but no significant change was observed in the 3D printed group (p>0.05). While the physical activity levels in the placebo group showed a significant improvement (p<0.05), physical activity level decreased in the 3D printed group (p>0.05).
Conclusions: In this study, it was found that the use of personalized insoles is effective in improving physical activity, balance and performance, while placebo insoles were found to be more effective in increasing muscle strength and explosive muscle strength.

Keywords

Balance, Physical Functional Performance, Pes planus

Ethical Statement

Dear Editor, The research name with “The Effect of Customized 3D Printed Insoles on Physical Activity Level, Balance and Physical Performance in Patients with Pes Planus: A randomized, placebo controlled, double-blind study” was conducted as a prospective study. Prior to approval from Izzet Baysal University Clinical Research Ethics Committee (no. 2021245-369) signed consent form was obtained from the participants. The authors of this study declare that the submitted manuscript has not been previously published, and the manuscript is not under simultaneous consideration for publication elsewhere, either in whole or in part in any language. In addition, authors report no conflict of interest and approve that manuscript does not contain any portion that may be regarded as redundant or duplicate information; defined as paper, data, tables, or figures that overlap substantially with already published information. Kindest Regards, Assist. Prof. Dr. Ramazan KURUL Department of Physical Therapy and Rehabilitation Abant Izzet Baysal University, Bolu, Turkey E- mail: [e-mail] Tel: [phone] - 4109 Fax: [phone]

Pes Planuslu Hastalarda Kişiye Özel Tasarlamış 3D Baskılı Tabanlıkların Fiziksel Aktivite Düzeyi, Denge ve Fiziksel Performans Üzerine Etkisi: Randomize, Plasebo Kontrollü, Çift-Kör Bir Çalışma

Abstract

Amaç: Bu çalışmanın amacı, pes planuslu hastalarda fiziksel aktivite seviyesi, denge ve fonksiyonel performans üzerine kişiye özel olarak tasarlanmış tabanlıkların etkilerini incelemektir.
Gereç ve Yöntem: 38 katılımcı 3D baskılı (n=20) ve plasebo (n=18) olmak üzere 2 gruba ayrıldı. 3D baskılı grupta, katılımcıların ihtiyacına göre tabanlıklara medial longitudinal ark desteği, ayak medial kaması, topuk medial kaması ve enine ark desteği verildi. Plasebo grubu ise plasebo tabanlık aldı. Kas gücü, hareket açıklığı, statik ve dinamik denge, fiziksel ve fiziksel aktivite seviyeleri başlangıçta ve sekiz hafta sonra ölçüldü (clinicaltrials. gov ID: NCT05306886).
Bulgular: Plantar fleksiyon ve eversiyon kas kuvvetleri, 3D baskı ve plasebo gruplarında artış gösterdi (sırasıyla p=0.030 ve p=0.020). Her iki grupta da statik denge değişmedi (p=0.386), ancak 3D baskı gruplarında dinamik denge önemli ölçüde arttı (p=0.019). Yürüme hızı hem 3D baskı (p=0.001) hem de plasebo gruplarında (p=0.015) arttı. Gruplar arasında patlayıcı güçte anlamlı farklılık görülmedi (p=0.272). Shuttle Run testi, plasebo grubunda anlamlı olarak gelişti (p=0.015), ancak 3D baskı grubunda anlamlı değişim gözlemlenmedi (p=0.886). Plasebo grubunda fiziksel aktivite seviyelerinde önemli bir gelişme görülürken (p=0.017), 3D baskı grubunda fiziksel aktivite seviyesi azaldı (p=0.489).
Sonuç: Bu çalışmada, kişiselleştirilmiş tabanlıkların kullanımının fiziksel aktivite, denge ve performansı iyileştirmede etkili olduğu, plasebo tabanlıkların ise kas gücü ve patlayıcı kas gücünü artırdığı bulunmuştur.

Keywords

Denge, Fiziksel Performans Seviyesi, Pes planus

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