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Идёт набор NCT07735949

Effects of Daily Footwear Use on Lower Extremity Health and Movement in Healthy Adults

Наблюдательное Healthy Volunteers Foot Biomechanics

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Healthy Volunteers, Foot Biomechanics. Базовые параметры: 18 лет — 35 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of Long-Term Daily Supportive and Flat Footwear Use on Foot Posture, Plantar Pressure Distribution and Balance in Healthy Adults: A Cross-Sectional Comparative Study

Обзор

Footwear is one of the most important external factors influencing lower extremity biomechanics, plantar sensory feedback, and postural control. Although supportive footwear provides cushioning and arch support, prolonged use may reduce intrinsic foot muscle activity and alter natural foot mechanics. Conversely, flat footwear may enhance plantar sensory input and foot muscle activation. However, evidence regarding the long-term biomechanical effects of habitual footwear use in healthy adults remains inconsistent. This cross-sectional comparative study aims to compare foot posture, plantar pressure distribution, and balance performance between healthy adults who have regularly worn supportive footwear or flat footwear for at least six months. Static plantar pressure distribution will be assessed using the Footwork system, while static and dynamic balance will be evaluated using the Biodex Balance System. The findings are expected to improve understanding of the long-term biomechanical consequences of habitual footwear selection.

Подробное описание

Footwear is one of the most influential external factors affecting lower extremity biomechanics, plantar sensory feedback, and postural control during daily activities. Modern footwear designs differ considerably in their structural characteristics, including cushioning, arch support, sole stiffness, and heel height. These features may alter foot mechanics, proprioceptive input, and neuromuscular control, potentially leading to long-term adaptations in balance and movement patterns. Supportive footwear is designed to improve comfort and reduce plantar loading through enhanced cushioning and medial arch support. However, prolonged use has been suggested to limit the natural motion of the foot and reduce activation of the intrinsic foot muscles. In contrast, flat footwear provides minimal structural support, allowing greater interaction between the plantar surface and the ground, which may enhance sensory feedback and promote more natural foot function.

Despite increasing interest in footwear biomechanics, evidence regarding the long-term effects of habitual footwear use in healthy individuals remains limited and inconsistent. Most previous studies have focused on the immediate effects of different shoe designs during walking or running, whereas few have investigated the chronic adaptations associated with everyday footwear habits. Furthermore, objective assessments combining plantar pressure analysis and computerized balance evaluation have rarely been used to compare individuals with different long-term footwear preferences.

The aim of this cross-sectional comparative study is to investigate whether habitual use of supportive or flat footwear is associated with differences in foot posture, plantar pressure distribution, and postural stability in healthy adults. Participants aged 18 to 35 years who have consistently worn either supportive or flat footwear for at least six months, for a minimum of six hours per day, will be recruited from the Faculty of Health Sciences at Bahçeşehir University.

Following informed consent, demographic characteristics, anthropometric measurements, and footwear history will be recorded. Static plantar pressure distribution and foot posture characteristics will be assessed using the Footwork Pedobarography System. Static and dynamic balance performance will be evaluated using the Biodex Balance System. Balance measurements will include double-leg and single-leg standing assessments, and objective stability indices will be recorded according to standardized testing protocols.

The primary outcomes will be the Overall Stability Index obtained from the Biodex Balance System and plantar pressure distribution parameters measured using the Footwork Pedobarography System. Secondary outcomes will include anterior-posterior and medial-lateral stability indices, foot contact area, arch-related plantar pressure characteristics, and balance performance during single-leg and double-leg stance.

It is hypothesized that individuals who habitually wear flat footwear will demonstrate different plantar pressure characteristics and balance performance compared with those who regularly wear supportive footwear, reflecting long-term biomechanical adaptations associated with footwear selection.

The findings of this study are expected to improve understanding of the relationship between habitual footwear use and lower extremity biomechanics in healthy adults. The results may contribute to evidence-based recommendations regarding footwear selection and support preventive strategies in physiotherapy, rehabilitation, sports medicine, and footwear design. Additionally, this study may provide a scientific basis for future longitudinal and interventional research investigating the long-term musculoskeletal consequences of everyday footwear habits.

Первичные конечные точки

  • Overall Stability Index (OSI) [Срок оценки: Baseline]
  • Plantar Pressure Distribution [Срок оценки: Baseline]
Вторичные конечные точки (4)
  • Foot Contact Area [Срок оценки: baseline]
  • Arch Index [Срок оценки: Baseline]
  • Anterior-Posterior Stability Index [Срок оценки: Baseline]
  • Single-leg Balance [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Adults aged 18 years and older
  • Diagnosis of hemophilia A or B
  • Scheduled to undergo primary total knee arthroplasty
  • Able to understand the study procedures and provide written informed consent
  • Willing to participate in the prehabilitation program

Критерии исключения

  • Presence of neurological disorders affecting balance or gait
  • Severe cognitive impairment
  • Other musculoskeletal conditions affecting lower extremity function
  • Revision total knee arthroplasty
  • Any medical condition that would prevent safe participation in the exercise program

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Bahcesehir university — Istanbul

Публикации

  • Sherafat S, Salavati M, Ebrahimi Takamjani I, Akhbari B, Mohammadirad S, Mazaheri M, Negahban H. Intrasession and intersession reliability of postural control in participants with and without nonspecific low back pain using the Biodex Balance System. J Manipulative Physiol Ther. 2013 Feb;36(2):111-8. doi: 10.1016/j.jmpt.2012.12.005. PMID 23499146
  • Ridge ST, Olsen MT, Bruening DA, Jurgensmeier K, Griffin D, Davis IS, Johnson AW. Walking in Minimalist Shoes Is Effective for Strengthening Foot Muscles. Med Sci Sports Exerc. 2019 Jan;51(1):104-113. doi: 10.1249/MSS.0000000000001751. PMID 30113521
  • Franklin S, Grey MJ, Heneghan N, Bowen L, Li FX. Barefoot vs common footwear: A systematic review of the kinematic, kinetic and muscle activity differences during walking. Gait Posture. 2015 Sep;42(3):230-9. doi: 10.1016/j.gaitpost.2015.05.019. Epub 2015 Jun 3. PMID 26220400
  • Cudejko T, Gardiner J, Akpan A, D'Aout K. Minimal footwear improves stability and physical function in middle-aged and older people compared to conventional shoes. Clin Biomech (Bristol). 2020 Jan;71:139-145. doi: 10.1016/j.clinbiomech.2019.11.005. Epub 2019 Nov 11. PMID 31739197
  • Chen TL, Sze LK, Davis IS, Cheung RT. Effects of training in minimalist shoes on the intrinsic and extrinsic foot muscle volume. Clin Biomech (Bristol). 2016 Jul;36:8-13. doi: 10.1016/j.clinbiomech.2016.05.010. Epub 2016 May 10. PMID 27195735

Идентификаторы

NCT: NCT07735949 · E-85646034-604.01-130496 · E-85646034-604.01-130496

Первоисточники (государственные реестры)

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