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Идёт набор NCT07229079

The Effectiveness of Basic Body Awareness Therapy in Individuals With Pes Planus

Без фазы С лечением Pes Planus

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 (BBAT), Short Foot Exercises (SFE).
Кому может быть актуально
Состояния в реестре: Pes Planus. Базовые параметры: 18 лет — 45 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
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Официальное название

The Effectiveness of Basic Body Awareness Therapy Combined With Short Foot Exercises in Individuals With Pes Planus

Обзор

This study investigates whether adding Basic Body Awareness Therapy (BBAT) to Short Foot Exercises (SFE) improves pes planus, balance, and body awareness in adults with flexible pes planus. Fifty participants aged 18-45 will be randomly assigned to either a BBAT + SFE group or an SFE-only control group. The interventions will last eight weeks with supervised sessions twice weekly and additional home exercises. Outcomes will be measured before, after, and two months post-intervention.

Подробное описание

Pes planus is a common orthopedic condition characterized by the collapse of the medial longitudinal arch of the foot, which negatively affects lower extremity biomechanics, postural stability, and balance. Currently, interventions targeting muscle activation-such as short foot exercises (SFE)-are widely used in the management of pes planus. However, it is believed that holistic approaches incorporating sensory input and body awareness may further enhance functional outcomes in these individuals. Basic Body Awareness Therapy (BBAT) is a physiotherapeutic method designed to improve movement quality, balance, and posture. In this study, BBAT will be applied for the first time in individuals with pes planus. This project aims to investigate the effects of BBAT, when combined with SFE, on medial longitudinal arch height, foot function, gait, balance, proprioception, plantar sensation, and body awareness in individuals with pes planus. The study will be conducted as a randomized controlled trial. Fifty participants who meet the inclusion criteria will be randomly assigned into two groups of 25: a BBAT group (SFE + BBAT) and a control group (SFE only). Interventions will be administered twice a week for a duration of eight weeks. Assessments will be conducted at three time points: before the intervention, immediately after the eight-week intervention period, and two months post-intervention (follow-up). This study aims to demonstrate that BBAT can provide significant improvements in both somatic and sensory parameters in individuals with pes planus, offering a holistic complement to traditional exercise-based approaches. In doing so, it is expected to contribute an innovative perspective to clinical physiotherapy practices and address a significant gap in the existing literature.

Вмешательства

  • Поведенческое Basic Body Awareness Therapy (BBAT)
    Participants will perform Basic Body Awareness Therapy (BBAT) combined with SFE for 8 weeks. BBAT sessions are 45 minutes, twice weekly in small groups under a certified physiotherapist. Exercises target postural control, motor coordination, body awareness, balance, and functional movement, progressing from supine to sitting, standing, and walking positions. After each BBAT session, participants perform SFE following the same progression as the Control Group.
  • Поведенческое Short Foot Exercises (SFE)
    Participants will perform Short Foot Exercises (SFE) for 8 weeks. Sessions are twice weekly under physiotherapist supervision in small groups (3-8 participants) and 5 days/week at home. Exercises progress from sitting (weeks 1-2), standing (weeks 3-4), single-leg (weeks 5-6), to functional activities (weeks 7-8). Each session lasts \~20 minutes, 3 sets of 10 reps with 1-minute rest. Participants receive instruction on proper technique and adherence is monitored online

Первичные конечные точки

  • Navicular Drop Test [Срок оценки: Baseline (pre-intervention), post-intervention (8 weeks), follow-up (2 months after intervention)]
  • Dynamic Balance [Срок оценки: Baseline, post-intervention (8 weeks), follow-up (2 months)]
  • Proprioception [Срок оценки: Baseline, post-intervention (8 weeks), follow-up (2 months)]
  • Light Touch Sensation [Срок оценки: Baseline, post-intervention (8 weeks), follow-up (2 months)]
Вторичные конечные точки (7)
  • Foot Function Index - Pain Subscale [Срок оценки: Baseline, post-intervention (8 weeks), follow-up (2 months)]
  • Foot Function Index - Disability Subscale [Срок оценки: Baseline, post-intervention (8 weeks), follow-up (2 months)]
  • Foot Function Index - Activity Limitation Subscale [Срок оценки: Baseline, post-intervention (8 weeks), follow-up (2 months)]
  • Foot Function Index - Total Score [Срок оценки: Baseline, post-intervention (8 weeks), follow-up (2 months)]
  • Static Balance [Срок оценки: Baseline, post-intervention (8 weeks), follow-up (2 months)]
  • Gait Performance [Срок оценки: Baseline, post-intervention (8 weeks), follow-up (2 months)]
  • Body Awareness [Срок оценки: Baseline, post-intervention (8 weeks), follow-up (2 months)]

Критерии участия

Критерии включения

  • Aged 18-45 years
  • Willing to participate in the study
  • Flexible pes planus (Navicular Drop ≥10 mm and positive Jack's Toe Raise Test)

Критерии исключения

  • Pain in lower extremity joints
  • Obesity (BMI >30)
  • Pregnancy
  • Systemic, neuromuscular, or neurological disorders
  • Posterior tibial tendon dysfunction (unable to perform heel-rise test)
  • History of lower limb surgery
  • Previous treatment for pes planus or use of foot orthoses
  • Lower extremity injury in past 6 months
  • Orthopedic conditions other than pes planus and mild hallux valgus (Manchester Scale C or D excluded)
  • Participation in regular exercise program in past 6 months
  • Prior personal experience with TBFT and/or short foot exercises

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Mardin Artuklu University — Mardin

Идентификаторы

NCT: NCT07229079 · FBYDRTEZ

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗