Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

14 lipca 2026 zaktualizowane przez: Özge ÇANKAYA, Hacettepe University

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

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.

Przegląd badań

Status

Rekrutacyjny

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

33

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Experimental: Basic Body Awareness Therapy-BBAT Group
Participants will receive a 12-week BBAT program, two sessions per week, with each session lasting approximately 45-60 minutes. Sessions will be supervised by a physiotherapist trained in BBAT.
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Gait Speed
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Gait speed will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles. Participants will be instructed to walk at maximum walking speed on a 10-meter walkway. The best test performance will be used for analysis. The metric will be recorded in meters/second.
Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Change in Cadence
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.

Cadence will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles and processed using MyoResearch 3.16. Cadence will be recorded as the number of steps per minute.

Unit of Measure: steps/min

Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Change in Step Length
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.

Step length will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles and processed using MyoResearch 3.16. Step length will be recorded in meters.

Unit of Measure: m

Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Change in Step Time
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.

Step time will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles and processed using MyoResearch 3.16. Step time will be recorded in seconds.

Unit of Measure: s

Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Change in Stride Time
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.

Stride time will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles and processed using MyoResearch 3.16. Stride time will be recorded in seconds.

Unit of Measure: s

Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Change in Stance Phase Duration
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.

Stance phase duration will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles and processed using MyoResearch 3.16. Stance phase duration will be recorded as a percentage of the gait cycle.

Unit of Measure: %

Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Change in Swing Phase Duration
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.

Swing phase duration will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles and processed using MyoResearch 3.16. Swing phase duration will be recorded as a percentage of the gait cycle.

Unit of Measure: %

Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Change in Gait Asymmetry Index
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.

The asymmetry index for gait-phase timing parameters will be calculated using the formula:

AI = [(Right - Left) / ((Right + Left)/2)] × 100

The asymmetry index will be expressed as a percentage, with higher values indicating greater gait asymmetry.

Unit of Measure: %

Baseline, after 12 weeks of intervention, and 3 months after intervention completion.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Static Plantar Load Distribution
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Static plantar load distribution will be assessed during one minute of comfortable bipedal standing using Noraxon Ultium instrumented insoles. Outcomes will include right-left load sharing and regional plantar pressure/load parameters.
Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Change in Dynamic Plantar Pressure Distribution During Walking
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Dynamic plantar pressure variables will be recorded during the 10-meter walk test. Plantar regions will be analyzed as heel, arch/midfoot, metatarsal, and toe segments. Variables will include regional pressure distribution and bilateral differences in plantar loading
Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Therapy Adherence
Ramy czasowe: Throughout the 12-week intervention period.
Attendance will be monitored using session attendance records. Therapy adherence will be defined as participation in at least 80% of planned BBAT sessions.
Throughout the 12-week intervention period.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Współpracownicy

Śledczy

  • Główny śledczy: Özge ÇANKAYA, PhD, Saglik Bilimleri Universitesi
  • Dyrektor Studium: Nilufer Keskin Dilbay, PhD, Saglik Bilimleri Universitesi

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

29 czerwca 2026

Zakończenie podstawowe (Szacowany)

29 września 2026

Ukończenie studiów (Szacowany)

4 stycznia 2027

Daty rejestracji na studia

Pierwszy przesłany

26 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 lipca 2026

Pierwszy wysłany (Rzeczywisty)

7 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 2026/144

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj