- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07598591
Basic Body Awareness Therapy (BBAT) and Corrective Exercise for Adolescent Hyperkyphosis
14. května 2026 aktualizováno: Ayse Zengin Alpozgen, Istanbul University - Cerrahpasa
The Effects of Basic Body Awareness Therapy Added to a Corrective Exercise Program on Body Image, Self-Esteem, and Posture in Adolescents With Postural Hyperkyphosis
This study is designed as a randomized controlled trial to evaluate the additional benefits of Basic Body Awareness Therapy (BBAT) when combined with a corrective exercise program for adolescents with postural hyperkyphosis.
Postural hyperkyphosis, defined as a thoracic kyphosis angle of 40 degrees or greater, often leads to physical misalignments and psychosocial issues such as decreased self-esteem and poor body image during adolescence.
Participants will be randomly assigned to either Group A (Experimental) or Group B (Control) using a stratified block randomization method.
Both groups will participate in a 12-week intervention consisting of supervised Schroth corrective exercises performed twice weekly.
Group A will additionally receive one session per week of BBAT, a physiotherapy method focusing on movement quality, mental awareness, and the integration of physical and mental self-awareness through lying, sitting, standing, and walking exercises.
Group B will receive Autogenic Training, a systematic relaxation technique, as an active control.
Assessments will be conducted at baseline and at the end of the 12-week program.
The primary outcome measures include body awareness (Body Awareness Questionnaire), aesthetic perception of the spine (Kyphosis Specific Spinal Appearance Questionnaire), self-esteem (Rosenberg Self-Esteem Scale), and digital posture analysis (PostureScreen Mobile).
Secondary outcomes involve clinical measurements of kyphosis (Flexicurve and Wall-Occiput Distance), dynamic and static balance (Y-Balance Test and Single-Leg Stance Test), thoracic joint position sense, health-related quality of life (SRS-30), and pain intensity (Numeric Pain Rating Scale).
The study aims to provide a comprehensive understanding of how mindfulness and movement awareness can enhance traditional physical rehabilitation for spinal postural disorders.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Detailní popis
This study is a randomized controlled trial designed to evaluate the impact of integrating Basic Body Awareness Therapy (BBAT) into a corrective exercise protocol for adolescents with postural hyperkyphosis.
Postural hyperkyphosis is defined in this study as a thoracic kyphosis angle of 40 degrees or greater.
The research explores how this combined approach affects physical posture as well as psychosocial variables like body image and self-esteem.
Participants will be randomly assigned to either the experimental group (Group A) or the control group (Group B) using stratified block randomization based on age and gender.
Both groups will undergo a 12-week intervention consisting of supervised Schroth corrective exercises performed twice weekly in a clinical setting.
Group A will receive an additional weekly session of BBAT.
This intervention focuses on movement quality and the integration of mental and physical self-awareness through a series of lying, sitting, standing, and walking exercises.
Group B will serve as the active control group and will receive Autogenic Training, which is a systematic relaxation technique, in addition to their corrective exercises.
Evaluations will be performed at baseline and after the 12-week intervention period.
Clinical assessments include digital posture analysis via PostureScreen Mobile and measurement of the thoracic kyphosis angle using the Flexicurve method and Wall-Occiput Distance.
Dynamic and static balance will be assessed using the Y-Balance Test and the Single-Leg Stance Test.
Furthermore, the study will measure thoracic joint position sense through active repositioning tests.
Psychosocial and quality-of-life data will be gathered using the Body Awareness Questionnaire, the Kyphosis Specific Spinal Appearance Questionnaire, the Rosenberg Self-Esteem Scale, and the SRS-30 questionnaire.
Typ studie
Intervenční
Zápis (Odhadovaný)
60
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Aslı YILDIRIM HAKANER
- Telefonní číslo: +905436088180
- E-mail: fzt.asliyildirim@gmail.com
Studijní záloha kontaktů
- Jméno: Ayşe Zengin Alpözgen, Assoc. Prof.
- E-mail: azengin@iuc.edu.tr
Studijní místa
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Istanbul, Turecko (Türkiye), 34500
- Istanbul University-Cerrahpasa
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Kontakt:
- Ayşe Zengin Alpözgen, Assoc. Prof.
- Telefonní číslo: 905526830479
- E-mail: azengin@iuc.edu.tr
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- Adolescents aged between 10 and 18 years.
- Diagnosis of postural hyperkyphosis confirmed by a thoracic kyphosis angle of 40 degrees or greater.
Exclusion Criteria:
- Diagnosis of congenital or rigid spinal deformities, such as Scheuermann's kyphosis.
- History of major spinal surgery, severe spinal trauma, or significant orthopedic conditions.
- Presence of diagnosed neurological or vestibular diseases that may affect balance or movement.
- Use of spinal braces or other corrective orthotic devices during the study period.
- Having received formal physiotherapy or a structured exercise program for posture within the last 6 months.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Group A
Participants in Group A will receive a multimodal program combining Schroth-based corrective exercises and Basic Body Awareness Therapy (BBAT).
The intervention includes posture-focused Schroth movements and BBAT elements such as body scanning, breathing awareness, and center-of-line stimulation.
The intervention will be delivered twice weekly over 12 weeks, with an additional weekly group BBAT session, totaling 36 supervised 60-minute sessions by a certified physiotherapist
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This is a behavioral, non-drug intervention combining Schroth corrective exercises with somatic awareness through Basic Body Awareness Therapy (BBAT).
Movements emphasize movement quality, postural alignment, and improved self-perception of the body.
The approach supports individualized progression (targeting 4-6 on a perceived difficulty scale) and complements conventional physiotherapy for adolescent hyperkyphosis.
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Aktivní komparátor: Group B
Participants in Group B will receive a program combining Schroth-based corrective exercises and Autogenic Training.
Corrective exercises will be performed with the same intensity and frequency as Group A, adjusted to individual tolerance.
Autogenic Training includes self-suggestion formulas for deep relaxation, focusing on sensations of heaviness and warmth.
The intervention will be delivered twice weekly over 12 weeks, totaling 24 supervised 60-minute sessions by a physiotherapist.
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This is a non-drug corrective exercise program tailored for adolescents with postural hyperkyphosis, combined with Autogenic Training for relaxation.
It includes spinal strengthening and Schroth-specific postural corrections performed twice weekly.
Additionally, participants perform Autogenic Training focusing on breathing, cardiac regulation, and abdominal warmth to support mental well-being alongside physical rehabilitation.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Body Awareness - Body Awareness Questionnaire (BAQ)
Časové okno: 12 weeks
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The Body Awareness Questionnaire is an 18-item scale designed to assess a person's sensitivity to non-pathological bodily processes, such as body rhythms and changes in bodily states.
Each item is rated on a 7-point Likert scale, with total scores ranging from 18 to 126.
A higher total score indicates a greater level of body awareness.
This measure will evaluate how the interventions influence the participants' internal perception of their bodies.
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12 weeks
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Aesthetic Perception of the Spine - Kyphosis Specific Spinal Appearance Questionnaire (KSAQ)
Časové okno: 12 weeks
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The Kyphosis Specific Spinal Appearance Questionnaire consists of 22 items specifically tailored to evaluate how adolescents with hyperkyphosis perceive the aesthetic appearance of their spine.
The scale uses a 5-point Likert system where higher scores reflect a more negative perception of spinal appearance and higher treatment expectations.
This tool provides insight into the psychosocial impact of postural changes and the perceived effectiveness of the treatment from the patient's perspective.
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12 weeks
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Self-Esteem - Rosenberg Self-Esteem Scale (RSES)
Časové okno: 12 weeks
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The Rosenberg Self-Esteem Scale is a widely validated 10-item instrument used to measure global self-worth and self-acceptance.
Participants rate each item on a 4-point Likert scale ranging from strongly agree to strongly disagree.
It captures both positive and negative feelings about the self, providing a total score that reflects the individual's overall level of self-esteem throughout the therapeutic process.
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12 weeks
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Posture Analysis - PostureScreen Mobile (PSM) Assessment
Časové okno: 12 weeks
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PostureScreen Mobile is a digital postural analysis application used to objectively quantify postural deviations.
It measures shifts and tilts in centimeters or degrees by analyzing photos taken from anterior, posterior, and lateral views.
The assessment focuses on identifying improvements in spinal alignment and the reduction of forward head posture or thoracic kyphosis after the 12-week intervention.
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12 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Thoracic Kyphosis Angle Measured by Flexicurve
Časové okno: 12 weeks
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The Flexicurve is a non-invasive, flexible ruler used to measure the curvature of the thoracic spine.
A physiotherapist molds the device to the participant's back, and the resulting curve is traced onto paper.
The kyphosis angle is then calculated using a mathematical formula based on the height and length of the curve.
Higher degrees indicate a greater degree of postural hyperkyphosis.
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12 weeks
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Wall-Occiput Distance (WOD)
Časové okno: 12 weeks
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This measurement is used to assess the severity of forward head posture and upper thoracic curvature.
The participant stands with their heels and back against a wall, and the horizontal distance between the occiput (the back of the head) and the wall is measured in centimeters using a standard ruler.
A distance of 0 cm is considered normal, while higher values indicate increased postural deviation.
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12 weeks
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Y-Balance Test (YBT)
Časové okno: 12 weeks
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The Y-Balance Test is a tool used to measure dynamic balance and functional reach.
Participants stand on one leg and reach with the other leg in three directions: anterior, posteromedial, and posterolateral.
The reach distances are recorded and normalized to the participant's leg length to provide a comprehensive balance score.
Higher scores represent better dynamic postural control.
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12 weeks
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Single-Leg Stance Test (SLS)
Časové okno: 12 weeks
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The Single-Leg Stance Test assesses static postural stability.
Participants are asked to stand on one leg with their eyes open and then with their eyes closed.
The duration they can maintain this position without the non-weight-bearing foot touching the ground or using their arms for balance is recorded in seconds, up to a maximum of 30 or 60 seconds.
Longer durations indicate superior static balance.
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12 weeks
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Joint Position Sense
Časové okno: 12 weeks
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Thoracic joint position sense will be assessed using an active repositioning test to evaluate proprioceptive accuracy.
A neutral thoracic position will be established as the reference position.
Participants will be instructed to perform thoracic movements in the specified direction and then return to the starting position with their eyes closed.
Repositioning error will be determined as the difference between the target position and the reproduced position.
One familiarization trial and three recorded trials will be performed, and the average value will be used for analysis.
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12 weeks
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Scoliosis Research Society-30 (SRS-30) Questionnaire
Časové okno: 12 weeks
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The SRS-30 is a patient-reported outcome measure specifically designed for spinal deformities.
It evaluates five domains: function/activity, pain, self-image, mental health, and satisfaction with treatment.
The questionnaire consists of 30 items, each rated on a 5-point scale.
Total scores range from 30 to 150, where higher scores reflect a better health-related quality of life.
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12 weeks
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Numeric Pain Rating Scale (NPRS)
Časové okno: 12 weeks
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The NPRS is a subjective 11-point scale used to measure the intensity of back pain.
Participants rate their pain on a scale from 0 (no pain) to 10 (worst imaginable pain).
This provides a quick and reliable quantitative measure of how the interventions impact physical discomfort associated with hyperkyphosis.
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12 weeks
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Global Rating of Change (GROC) Scale
Časové okno: 12 weeks
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The Global Rating of Change (GROC) scale is a self-reported instrument used to assess a participant's perception of their overall improvement or deterioration over the course of the 12-week study.
Participants rate their change on an 11-point or 15-point scale (commonly ranging from -7 "a very great deal worse" to 0 "no change" to +7 "a very great deal better").
This measure captures the clinical relevance of the intervention from the patient's perspective, beyond objective physical measurements.
A higher positive score indicates a more significant perceived improvement in the participant's condition.
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12 weeks
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Ayşe Zengin Alpözgen, Assoc Prof., Istanbul University - Cerrahpasa
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
29. května 2026
Primární dokončení (Odhadovaný)
29. května 2027
Dokončení studie (Odhadovaný)
29. července 2027
Termíny zápisu do studia
První předloženo
14. května 2026
První předloženo, které splnilo kritéria kontroly kvality
14. května 2026
První zveřejněno (Aktuální)
20. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
20. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
14. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
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