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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, , 67 - 76, 14.03.2024
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.

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: ramazankurul2@hotmail.com Tel: +90 254 10 00 - 4109 Fax: +90 374 253 46 63

References

  • 1. Choi HS, Baek YS. Effects of the degree of freedom and assistance characteristics of powered ankle-foot orthoses on gait stability. PloS one. 2020;15(11):e0242000.
  • 2. Kim D, Lewis CL, Gill SV. Effects of obesity and foot arch height on gait mechanics: A cross-sectional study. Plos one. 2021;16(11):e0260398.
  • 3. Neville C, Flemister A, Tome J, Houck J. Comparison of changes in posterior tibialis muscle length between subjects with posterior tibial tendon dysfunction and healthy controls during walking. journal of orthopaedic & sports physical therapy. 2007;37(11):661-9.
  • 4. Watanabe K, Kitaoka HB, Fujii T, Crevoisier X, Berglund LJ, Zhao KD, et al. Posterior tibial tendon dysfunction and flatfoot: analysis with simulated walking. Gait & posture. 2013;37(2):264-8.
  • 5. Williams G, Widnall J, Evans P, Platt S. Could failure of the spring ligament complex be the driving force behind the development of the adult flatfoot deformity? The Journal of foot and ankle surgery. 2014;53(2):152-5.
  • 6. Marzano R. Functional bracing of the adult acquired flatfoot. Clinics in Podiatric Medicine and Surgery. 2007;24(4):645-56.
  • 7. Nielsen MD, Dodson EE, Shadrick DL, Catanzariti AR, Mendicino RW, Malay DS. Nonoperative care for the treatment of adult-acquired flatfoot deformity. The Journal of foot and ankle surgery. 2011;50(3):311-4.
  • 8. Svoboda Z, Honzikova L, Jaroszczuk S, Vidal T, Martinaskova E. Kinematic gait analysis in children with valgus deformity of the hindfoot. Acta of Bioengineering and Biomechanics. 2014;16(3):89-93.
  • 9. Xu Y, Yuan P, Wang R, Wang D, Liu J, Zhou H. Effects of foot strike techniques on running biomechanics: a systematic review and meta-analysis. Sports Health. 2021;13(1):71-7.
  • 10. Taş S, Aktaş A, Tüfek MT. Passive mechanical properties of extrinsic foot muscles and Achilles tendon in adults with and without pes planus. Journal of Biomechanics. 2022;133:110961.
  • 11. Chevalier TL, Chockalingam N. Effects of foot orthoses: How important is the practitioner? Gait & posture. 2012;35(3):383-8.
  • 12. Marzano R. Nonoperative management of adult flatfoot deformities. Clinics in Podiatric Medicine and Surgery. 2014;31(3):337-47.
  • 13. Daryabor A, Kobayashi T, Saeedi H, Lyons SM, Maeda N, Naimi SS. Effect of 3D printed insoles for people with flatfeet: A systematic review. Assistive Technology. 2023;35(2):169-79.
  • 14. Zhang B, Yu X, Liang L, Zhu L, Dong X, Xiong Y, et al. Is the wedged insole an effective treatment option when compared with a flat (placebo) insole: a systematic review and meta-analysis. Evidence-Based Complementary and Alternative Medicine. 2018;2018.
  • 15. Buldt AK, Forghany S, Landorf KB, Levinger P, Murley GS, Menz HB. Foot posture is associated with plantar pressure during gait: A comparison of normal, planus and cavus feet. Gait & posture. 2018;62:235-40.
  • 16. Banwell HA, Paris ME, Mackintosh S, Williams CM. Paediatric flexible flat foot: how are we measuring it and are we getting it right? A systematic review. Journal of foot and ankle research. 2018;11(1):1-13.
  • 17. Redmond AC, Crosbie J, Ouvrier RA. Development and validation of a novel rating system for scoring standing foot posture: the Foot Posture Index. Clinical biomechanics. 2006;21(1):89-98.
  • 18. Pfeiffer M, Kotz R, Ledl T, Hauser G, Sluga M. Prevalence of flat foot in preschool-aged children. Pediatrics. 2006;118(2):634-9. 19. Markovic G, Dizdar D, Jukic I, Cardinale M. Reliability and factorial validity of squat and countermovement jump tests. The Journal of Strength & Conditioning Research. 2004;18(3):551-5.
  • 20. Hébert-Losier K, Newsham-West RJ, Schneiders AG, Sullivan SJ. Raising the standards of the calf-raise test: a systematic review. Journal of Science and Medicine in Sport. 2009;12(6):594-602.
  • 21. Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Perceptual and motor skills. 2010;111(1):278-84.
  • 22. Araújo VL, Souza TR, Magalhães FA, Santos TR, Holt KG, Fonseca ST. Effects of a foot orthosis inspired by the concept of a twisted osteoligamentous plate on the kinematics of foot-ankle complex during walking: A proof of concept. Journal of biomechanics. 2019;93:118-25.
  • 23. Wahmkow G, Cassel M, Mayer F, Baur H. Effects of different medial arch support heights on rearfoot kinematics. PloS one. 2017;12(3):e0172334.
  • 24. Zhao X, Tsujimoto T, Kim B, Tanaka K. Association of arch height with ankle muscle strength and physical performance in adult men. Biology of sport. 2017;34(2):119-26.
  • 25. Nigg B, Wakeling J. Impact forces and muscle tuning: a new paradigm. Exercise and sport sciences reviews. 2001;29(1):37-41.
  • 26. Jung D-Y, Koh E-K, Kwon O-Y. Effect of foot orthoses and short-foot exercise on the cross-sectional area of the abductor hallucis muscle in subjects with pes planus: a randomized controlled trial. Journal of back and musculoskeletal rehabilitation. 2011;24(4):225-31.
  • 27. Baur H, Hirschmüller A, Mueller S, Mayer F. Neuromuscular activity of the peroneal muscle after foot orthoses therapy in runners. Medicine and science in sports and exercise. 2011;43(8):1500-6.
  • 28. Alvarez RG, Marini A, Schmitt C, Saltzman CL. Stage I and II posterior tibial tendon dysfunction treated by a structured nonoperative management protocol: an orthosis and exercise program. Foot & ankle international. 2006;27(1):2-8.
  • 29. Kim E-K, Kim JS. The effects of short foot exercises and arch support insoles on improvement in the medial longitudinal arch and dynamic balance of flexible flatfoot patients. Journal of physical therapy science. 2016;28(11):3136-9.
  • 30. Tudor A, Ruzic L, Sestan B, Sirola L, Prpić T. Flat-footedness is not a disadvantage for athletic performance in children aged 11 to 15 years. Pediatrics. 2009;123(3):e386-e92.
  • 31. Okunuki T, Koshino Y, Yamanaka M, Tsutsumi K, Igarashi M, Samukawa M, et al. Forefoot and hindfoot kinematics in subjects with medial tibial stress syndrome during walking and running. Journal of Orthopaedic Research®. 2019;37(4):927-32.
  • 32. Franz JR, Wierzbinski CM, Kram R. Metabolic cost of running barefoot versus shod: is lighter better? Medicine & Science in Sports & Exercise. 2012;44(8):1519-25.
  • 33. Hoogkamer W, Kipp S, Spiering BA, Kram R. Altered running economy directly translates to altered distance-running performance. Med Sci Sports Exerc. 2016;48(11):2175-80.
  • 34. Crago D, Bishop C, Arnold JB. The effect of foot orthoses and insoles on running economy and performance in distance runners: A systematic review and meta-analysis. Journal of Sports Sciences. 2019;37(22):2613-24.
  • 35. Chander H, Morris CE, Wilson SJ, Garner JC, Wade C. Impact of alternative footwear on human balance. Footwear Science. 2016;8(3):165-74.
  • 36. López-López D, Vilar-Fernández JM, Barros-García G, Losa-Iglesias ME, Palomo-López P, Becerro-de-Bengoa-Vallejo R, Calvo-Lobo C. Foot arch height and quality of life in adults: a strobe observational study. International Journal of Environmental Research and Public Health. 2018;15(7):1555.
  • 37. Wrobel JS, Fleischer AE, Crews RT, Jarrett B, Najafi B. A randomized controlled trial of custom foot orthoses for the treatment of plantar heel pain. Journal of the American Podiatric Medical Association. 2015;105(4):281-94.

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

Year 2024, , 67 - 76, 14.03.2024
https://doi.org/10.18521/ktd.1353248

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.

References

  • 1. Choi HS, Baek YS. Effects of the degree of freedom and assistance characteristics of powered ankle-foot orthoses on gait stability. PloS one. 2020;15(11):e0242000.
  • 2. Kim D, Lewis CL, Gill SV. Effects of obesity and foot arch height on gait mechanics: A cross-sectional study. Plos one. 2021;16(11):e0260398.
  • 3. Neville C, Flemister A, Tome J, Houck J. Comparison of changes in posterior tibialis muscle length between subjects with posterior tibial tendon dysfunction and healthy controls during walking. journal of orthopaedic & sports physical therapy. 2007;37(11):661-9.
  • 4. Watanabe K, Kitaoka HB, Fujii T, Crevoisier X, Berglund LJ, Zhao KD, et al. Posterior tibial tendon dysfunction and flatfoot: analysis with simulated walking. Gait & posture. 2013;37(2):264-8.
  • 5. Williams G, Widnall J, Evans P, Platt S. Could failure of the spring ligament complex be the driving force behind the development of the adult flatfoot deformity? The Journal of foot and ankle surgery. 2014;53(2):152-5.
  • 6. Marzano R. Functional bracing of the adult acquired flatfoot. Clinics in Podiatric Medicine and Surgery. 2007;24(4):645-56.
  • 7. Nielsen MD, Dodson EE, Shadrick DL, Catanzariti AR, Mendicino RW, Malay DS. Nonoperative care for the treatment of adult-acquired flatfoot deformity. The Journal of foot and ankle surgery. 2011;50(3):311-4.
  • 8. Svoboda Z, Honzikova L, Jaroszczuk S, Vidal T, Martinaskova E. Kinematic gait analysis in children with valgus deformity of the hindfoot. Acta of Bioengineering and Biomechanics. 2014;16(3):89-93.
  • 9. Xu Y, Yuan P, Wang R, Wang D, Liu J, Zhou H. Effects of foot strike techniques on running biomechanics: a systematic review and meta-analysis. Sports Health. 2021;13(1):71-7.
  • 10. Taş S, Aktaş A, Tüfek MT. Passive mechanical properties of extrinsic foot muscles and Achilles tendon in adults with and without pes planus. Journal of Biomechanics. 2022;133:110961.
  • 11. Chevalier TL, Chockalingam N. Effects of foot orthoses: How important is the practitioner? Gait & posture. 2012;35(3):383-8.
  • 12. Marzano R. Nonoperative management of adult flatfoot deformities. Clinics in Podiatric Medicine and Surgery. 2014;31(3):337-47.
  • 13. Daryabor A, Kobayashi T, Saeedi H, Lyons SM, Maeda N, Naimi SS. Effect of 3D printed insoles for people with flatfeet: A systematic review. Assistive Technology. 2023;35(2):169-79.
  • 14. Zhang B, Yu X, Liang L, Zhu L, Dong X, Xiong Y, et al. Is the wedged insole an effective treatment option when compared with a flat (placebo) insole: a systematic review and meta-analysis. Evidence-Based Complementary and Alternative Medicine. 2018;2018.
  • 15. Buldt AK, Forghany S, Landorf KB, Levinger P, Murley GS, Menz HB. Foot posture is associated with plantar pressure during gait: A comparison of normal, planus and cavus feet. Gait & posture. 2018;62:235-40.
  • 16. Banwell HA, Paris ME, Mackintosh S, Williams CM. Paediatric flexible flat foot: how are we measuring it and are we getting it right? A systematic review. Journal of foot and ankle research. 2018;11(1):1-13.
  • 17. Redmond AC, Crosbie J, Ouvrier RA. Development and validation of a novel rating system for scoring standing foot posture: the Foot Posture Index. Clinical biomechanics. 2006;21(1):89-98.
  • 18. Pfeiffer M, Kotz R, Ledl T, Hauser G, Sluga M. Prevalence of flat foot in preschool-aged children. Pediatrics. 2006;118(2):634-9. 19. Markovic G, Dizdar D, Jukic I, Cardinale M. Reliability and factorial validity of squat and countermovement jump tests. The Journal of Strength & Conditioning Research. 2004;18(3):551-5.
  • 20. Hébert-Losier K, Newsham-West RJ, Schneiders AG, Sullivan SJ. Raising the standards of the calf-raise test: a systematic review. Journal of Science and Medicine in Sport. 2009;12(6):594-602.
  • 21. Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Perceptual and motor skills. 2010;111(1):278-84.
  • 22. Araújo VL, Souza TR, Magalhães FA, Santos TR, Holt KG, Fonseca ST. Effects of a foot orthosis inspired by the concept of a twisted osteoligamentous plate on the kinematics of foot-ankle complex during walking: A proof of concept. Journal of biomechanics. 2019;93:118-25.
  • 23. Wahmkow G, Cassel M, Mayer F, Baur H. Effects of different medial arch support heights on rearfoot kinematics. PloS one. 2017;12(3):e0172334.
  • 24. Zhao X, Tsujimoto T, Kim B, Tanaka K. Association of arch height with ankle muscle strength and physical performance in adult men. Biology of sport. 2017;34(2):119-26.
  • 25. Nigg B, Wakeling J. Impact forces and muscle tuning: a new paradigm. Exercise and sport sciences reviews. 2001;29(1):37-41.
  • 26. Jung D-Y, Koh E-K, Kwon O-Y. Effect of foot orthoses and short-foot exercise on the cross-sectional area of the abductor hallucis muscle in subjects with pes planus: a randomized controlled trial. Journal of back and musculoskeletal rehabilitation. 2011;24(4):225-31.
  • 27. Baur H, Hirschmüller A, Mueller S, Mayer F. Neuromuscular activity of the peroneal muscle after foot orthoses therapy in runners. Medicine and science in sports and exercise. 2011;43(8):1500-6.
  • 28. Alvarez RG, Marini A, Schmitt C, Saltzman CL. Stage I and II posterior tibial tendon dysfunction treated by a structured nonoperative management protocol: an orthosis and exercise program. Foot & ankle international. 2006;27(1):2-8.
  • 29. Kim E-K, Kim JS. The effects of short foot exercises and arch support insoles on improvement in the medial longitudinal arch and dynamic balance of flexible flatfoot patients. Journal of physical therapy science. 2016;28(11):3136-9.
  • 30. Tudor A, Ruzic L, Sestan B, Sirola L, Prpić T. Flat-footedness is not a disadvantage for athletic performance in children aged 11 to 15 years. Pediatrics. 2009;123(3):e386-e92.
  • 31. Okunuki T, Koshino Y, Yamanaka M, Tsutsumi K, Igarashi M, Samukawa M, et al. Forefoot and hindfoot kinematics in subjects with medial tibial stress syndrome during walking and running. Journal of Orthopaedic Research®. 2019;37(4):927-32.
  • 32. Franz JR, Wierzbinski CM, Kram R. Metabolic cost of running barefoot versus shod: is lighter better? Medicine & Science in Sports & Exercise. 2012;44(8):1519-25.
  • 33. Hoogkamer W, Kipp S, Spiering BA, Kram R. Altered running economy directly translates to altered distance-running performance. Med Sci Sports Exerc. 2016;48(11):2175-80.
  • 34. Crago D, Bishop C, Arnold JB. The effect of foot orthoses and insoles on running economy and performance in distance runners: A systematic review and meta-analysis. Journal of Sports Sciences. 2019;37(22):2613-24.
  • 35. Chander H, Morris CE, Wilson SJ, Garner JC, Wade C. Impact of alternative footwear on human balance. Footwear Science. 2016;8(3):165-74.
  • 36. López-López D, Vilar-Fernández JM, Barros-García G, Losa-Iglesias ME, Palomo-López P, Becerro-de-Bengoa-Vallejo R, Calvo-Lobo C. Foot arch height and quality of life in adults: a strobe observational study. International Journal of Environmental Research and Public Health. 2018;15(7):1555.
  • 37. Wrobel JS, Fleischer AE, Crews RT, Jarrett B, Najafi B. A randomized controlled trial of custom foot orthoses for the treatment of plantar heel pain. Journal of the American Podiatric Medical Association. 2015;105(4):281-94.
There are 36 citations in total.

Details

Primary Language English
Subjects Health Services and Systems (Other)
Journal Section Articles
Authors

Enes Öztürk This is me 0000-0002-7205-0109

Ramazan Kurul 0000-0001-8605-8286

Publication Date March 14, 2024
Acceptance Date February 28, 2024
Published in Issue Year 2024

Cite

APA Öztürk, E., & Kurul, R. (2024). 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. Konuralp Medical Journal, 16(1), 67-76. https://doi.org/10.18521/ktd.1353248
AMA Öztürk E, Kurul R. 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. Konuralp Medical Journal. March 2024;16(1):67-76. doi:10.18521/ktd.1353248
Chicago Öztürk, Enes, and Ramazan Kurul. “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”. Konuralp Medical Journal 16, no. 1 (March 2024): 67-76. https://doi.org/10.18521/ktd.1353248.
EndNote Öztürk E, Kurul R (March 1, 2024) 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. Konuralp Medical Journal 16 1 67–76.
IEEE E. Öztürk and R. Kurul, “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”, Konuralp Medical Journal, vol. 16, no. 1, pp. 67–76, 2024, doi: 10.18521/ktd.1353248.
ISNAD Öztürk, Enes - Kurul, Ramazan. “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”. Konuralp Medical Journal 16/1 (March 2024), 67-76. https://doi.org/10.18521/ktd.1353248.
JAMA Öztürk E, Kurul R. 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. Konuralp Medical Journal. 2024;16:67–76.
MLA Öztürk, Enes and Ramazan Kurul. “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”. Konuralp Medical Journal, vol. 16, no. 1, 2024, pp. 67-76, doi:10.18521/ktd.1353248.
Vancouver Öztürk E, Kurul R. 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. Konuralp Medical Journal. 2024;16(1):67-76.