- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07688785
Effects of Basic Body Awareness Therapy on Gait and Plantar Pressure in Healthy Young Adults
Effects of Basic Body Awareness Therapy on Spatiotemporal Gait Characteristics and Plantar Pressure Distribution in Healthy Young Adults
Przegląd badań
Status
Warunki
Interwencja / Leczenie
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
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Özge Çankaya, PhD
- Numer telefonu: +905053732255
- E-mail: ozgemuezzinoglu@gmail.com
Lokalizacje studiów
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Ankara, Turcja (Türkiye), 06100
- Rekrutacyjny
- University of Health Sciences
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Kontakt:
- Özge Çankaya
- Numer telefonu: +905053732255
- E-mail: ozgemuezzinoglu@gmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
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
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 |
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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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Gait Speed
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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.
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Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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Change in Cadence
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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.
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Change in Step Length
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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.
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Change in Step Time
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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.
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Change in Stride Time
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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.
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Change in Stance Phase Duration
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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.
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Change in Swing Phase Duration
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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.
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Change in Gait Asymmetry Index
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Static Plantar Load Distribution
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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.
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Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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Change in Dynamic Plantar Pressure Distribution During Walking
Ramy czasowe: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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
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Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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Therapy Adherence
Ramy czasowe: Throughout the 12-week intervention period.
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Attendance will be monitored using session attendance records.
Therapy adherence will be defined as participation in at least 80% of planned BBAT sessions.
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Throughout the 12-week intervention period.
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Özge ÇANKAYA, PhD, Saglik Bilimleri Universitesi
- Dyrektor Studium: Nilufer Keskin Dilbay, PhD, Saglik Bilimleri Universitesi
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 2026/144
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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