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Идёт набор NCT07688785

Effects of Basic Body Awareness Therapy on Gait and Plantar Pressure in Healthy Young Adults

Без фазы С лечением Gait Body Awareness

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
В протоколе указаны: Basic Body Awareness Therapy.
Кому может быть актуально
Состояния в реестре: Gait, Body Awareness. Базовые параметры: 18 лет — 25 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 Basic Body Awareness Therapy on Spatiotemporal Gait Characteristics and Plantar Pressure Distribution in Healthy Young Adults

Обзор

This interventional study will evaluate the effects of Basic Body Awareness Therapy (BBAT) on gait and plantar pressure outcomes in healthy young adults. Participants aged 18 to 25 years will receive a 12-week BBAT program delivered twice weekly by a physiotherapist trained in BBAT. Outcomes will be assessed at baseline, after the 12-week intervention, and at 3-month follow-up. The primary aim is to determine changes in gait speed and other spatiotemporal gait parameters during the 10-meter walk test. Secondary aims are to examine changes in static and dynamic plantar load distribution, right-left load sharing, and regional plantar pressure parameters. The study hypothesizes that BBAT will improve gait speed, reduce right-left differences in spatiotemporal gait parameters, improve bilateral load distribution during static stance and walking, and maintain these gains at 3-month follow-up.

Подробное описание

Gait is a functional task requiring integrated postural control, sensorimotor processing, muscle coordination, and adaptation to the environment. Gait speed and related spatiotemporal parameters are sensitive indicators of functional status and movement capacity. Body awareness refers to the conscious perception and regulation of posture, movement quality, proprioceptive input, and interoceptive sensations. Basic Body Awareness Therapy is a physiotherapy-based mind-body approach that focuses on posture, balance, coordination, breathing, weight transfer, trunk control, and movement quality.

This study is designed as a single-group, quasi-experimental interventional study with repeated assessments. After completion of the informed consent process, demographic and health-related data will be collected. Gait and static stance measurements will be performed using Noraxon Ultium instrumented insoles. For static stance, participants will stand comfortably on both feet for one minute while plantar load distribution and right-left weight sharing are recorded. Participants will then complete the 10-meter walk test at maximum walking speed. Plantar loading data, including pressure distribution, step length, step time, stance and swing phases, and regional plantar pressure variables, will be processed using MyoResearch 3.16 software. The gait cycle will be normalized to 100%, divided into stance and swing phases, and plantar regions will be analyzed as heel, arch/midfoot, metatarsal, and toe segments.

The BBAT intervention will be delivered for 12 weeks, twice per week, with each session lasting approximately 45 to 60 minutes. Sessions will be supervised by a physiotherapist who has completed BBAT Level C training. The program will consist of low-intensity exercises focusing on awareness of contact with the floor, postural alignment, breathing and movement integration, weight transfer, trunk control, balance, and fluent movement quality. Therapy adherence will be monitored using attendance records, and adherence will be defined as participation in at least 80% of planned sessions. Measurements will be repeated after the 12-week intervention and 3 months after intervention completion to assess short-term effects and early maintenance of behavioral change.

The sample size was determined using G\*Power 3.1 software. Considering the single-group design with three repeated measurements (pre-test, post-test at week 12, and 3-month follow-up), the parameters were set as a medium effect size of f = 0.25, an alpha error probability of 0.05, a power (1-β) of 0.80, a correlation among repeated measures of 0.50, and a non-sphericity correction ε = 1.00. Based on these parameters, the required sample size was calculated as 28 participants. Considering a possible dropout/follow-up loss rate of approximately 15%, the target sample size was determined as 33 participants.

Вмешательства

  • Другое Basic Body Awareness Therapy
    The Basic Body Awareness Therapy program includes low-intensity physiotherapy exercises focused on awareness of contact with the floor, postural alignment, breathing-movement integration, weight transfer, trunk control, balance, and fluent movement quality.

Первичные конечные точки

  • Change in Gait Speed [Срок оценки: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.]
  • Change in Cadence [Срок оценки: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.]
  • Change in Step Length [Срок оценки: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.]
  • Change in Step Time [Срок оценки: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.]
  • Change in Stride Time [Срок оценки: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.]
  • Change in Stance Phase Duration [Срок оценки: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.]
  • Change in Swing Phase Duration [Срок оценки: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.]
  • Change in Gait Asymmetry Index [Срок оценки: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.]
Вторичные конечные точки (3)
  • Change in Static Plantar Load Distribution [Срок оценки: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.]
  • Change in Dynamic Plantar Pressure Distribution During Walking [Срок оценки: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.]
  • Therapy Adherence [Срок оценки: Throughout the 12-week intervention period.]

Критерии участия

Критерии включения

  • Aged 18 to 25 years
  • Able to walk independently
  • No history of lower-extremity, spine, or balance-affecting trauma and/or surgery within the last 6 months
  • Not receiving regular Basic Body Awareness Therapy
  • Provides written informed consent

Критерии исключения

  • History of neurological, vestibular, or rheumatological disease
  • Acute musculoskeletal injury
  • Serious visual or hearing impairment
  • Pain, deformity, or assistive device use that may affect walking performance
  • Participation in a physiotherapy program and/or regular exercise program within the last 6 months
  • Any condition preventing regular participation in assessment or therapy sessions

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр
  • University of Health Sciences — Ankara

Идентификаторы

NCT: NCT07688785 · 2026/144

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗