- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Özge Çankaya, PhD
- Número de teléfono: +905053732255
- Correo electrónico: ozgemuezzinoglu@gmail.com
Ubicaciones de estudio
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Ankara, Turquía (Türkiye), 06100
- Reclutamiento
- University of Health Sciences
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Contacto:
- Özge Çankaya
- Número de teléfono: +905053732255
- Correo electrónico: ozgemuezzinoglu@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Gait Speed
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Static Plantar Load Distribution
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Özge ÇANKAYA, PhD, Saglik Bilimleri Universitesi
- Director de estudio: Nilufer Keskin Dilbay, PhD, Saglik Bilimleri Universitesi
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2026/144
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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