- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07500883
Basic Body Awareness Therapy Added to Scoliosis-Specific Exercise in Adolescents With Scoliosis
Effects of Integrating Basic Body Awareness Therapy Into Scoliosis-Specific Exercises on Body Awareness, Quality of Life, and Scoliosis-Related Outcomes in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial
The goal of this randomised clinical trial is to evaluate whether adding Basic Body Awareness Therapy (BBAT) to scoliosis-specific exercises can improve body awareness, quality of life and scoliosis-speficic outcomes in adolescents aged 10-17 years with adolescent idiopathic scoliosis (AIS). The main questions it aims to answer are:
Does the addition of BBAT to scoliosis-specific exercises lead to greater improvements in body awareness compared to scoliosis-specific exercises alone? Does adding BBAT improve trunk proprioception, scoliosis-related parameters, and health-related quality of life in adolescents with AIS?
H1: Adolescents with idiopathic scoliosis who receive Basic Body Awareness Therapy in addition to scoliosis-specific exercises will demonstrate greater improvements in body awareness compared to those receiving scoliosis-specific exercises alone.
H2: Adolescents receiving Basic Body Awareness Therapy in addition to scoliosis-specific exercises will demonstrate greater improvements in scoliosis-related clinical parameters compared to those receiving scoliosis-specific exercises alone.
H3: Adolescents receiving Basic Body Awareness Therapy in addition to scoliosis-specific exercises will demonstrate greater improvements in both general and scoliosis-specific quality of life compared to those receiving scoliosis-specific exercises alone.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that may affect not only spinal alignment but also postural control and body perception. Recent evidence suggests that, beyond structural deformity, alterations in sensory integration and body awareness may contribute to postural asymmetry in individuals with AIS. These findings highlight the importance of addressing both structural and perceptual components in rehabilitation.
Physiotherapeutic scoliosis-specific exercises (PSSE) are widely used in the conservative management of AIS and aim to improve spinal alignment through active self-correction and functional stabilization. While PSSE has demonstrated positive effects on scoliosis-related clinical outcomes, its effects on perceptual aspects such as body awareness remain less explored. Therefore, integrating interventions that specifically target body awareness may enhance rehabilitation outcomes.
Basic Body Awareness Therapy (BBAT) is a movement-based approach that focuses on posture, movement quality, breathing, and awareness of bodily sensations. By promoting conscious perception of body alignment and movement, BBAT may support improvements in postural control and functional organization in individuals with AIS. For this reason, BBAT was incorporated as a complementary intervention alongside PSSE.
This study is designed as a randomized controlled trial to investigate the effects of adding BBAT to a PSSE-based rehabilitation program. Participants will be randomly assigned to either a control group receiving PSSE alone or an intervention group receiving PSSE combined with BBAT. Both groups will participate in supervised sessions once per week for 6 months and perform home-based exercises on the remaining days.
Outcome measures will include body awareness, health-related quality of life, and scoliosis-specific clinical parameters. Assessments will be conducted at baseline and after 6 months.
This study aims to determine whether the addition of BBAT to conventional exercise-based rehabilitation provides additional benefits in adolescents with AIS.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: SENA NUR YAYLACI, MSc, PT
- Phone Number: +905446515570
- Email: senayaylaciii@gmail.com
Study Locations
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Ankara
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Ankara, Ankara, Turkey (Türkiye)
- Recruiting
- Hacettepe University Faculty of Physical Therapy and Rehabilitation, Orthotics and Biomechanics Clinic
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Contact:
- GÖZDE YAĞCI, Prof. Dr.
- Phone Number: +905054274351
- Email: gozdeygc8@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed of adolescent idiopathic scoliosis
- Age between 10 and 17 years
- Cobb angle ≥15°
- No previous or concurrent scoliosis treatment
- Risser sign between 0 and 4
Exclusion Criteria:
- Evidence of congenital scoliosis or other spinal deformities (e.g., hyperkyphosis, pectus deformities)
- Diagnosis of neuromuscular, rheumatologic, neurological, cardiovascular, pulmonary disorders
- Regular participation in sports
- History of spinal orthosis use or scoliosis surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control group
Participants in this group will receive only scoliosis-specific exercises.
Scientific Exercise Approach to Scoliosis (SEAS) approach will be used.
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This approach aims to improve spinal stabilization and postural control through active self-correction.
Exercises are performed in basic positions and progressively advance to more complex functional tasks according to individual ability.
The program follows a structured yet individualized approach tailored to each participant's needs.
All exercises are administered and supervised by an experienced, certified physiotherapist.
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Active Comparator: BBAT group
Participants in this group will receive Basic Body Awareness Therapy (BBAT) in addition to scoliosis-specific exercises (SEAS approach).
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This approach aims to improve spinal stabilization and postural control through active self-correction.
Exercises are performed in basic positions and progressively advance to more complex functional tasks according to individual ability.
The program follows a structured yet individualized approach tailored to each participant's needs.
All exercises are administered and supervised by an experienced, certified physiotherapist.
BBAT sessions include movements performed in basic and functional positions such as lying, sitting, standing, and walking, integrated with breathing and awareness of bodily sensations.
The program aims to improve body awareness, movement quality, and postural control through slow, rhythmic, and coordinated movements.
Movements emphasize grounding, alignment of body segments, weight transfer, and coordinated breathing.
Participants are instructed to perform movements slowly and with attention to bodily perception.
The program follows a structured yet individualized progression based on each participant's abilities under the supervision of a certified physiotherapist.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Awareness Questionnaire (BAQ)
Time Frame: 6 months
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The Body Awareness Questionnaire (BAQ) is a self-reported instrument originally developed by Shields et al. in 1989.
The Turkish version has been shown to be valid and reliable in healthy individuals.
The questionnaire assesses awareness of bodily processes, including sensitivity to bodily responses, prediction of bodily reactions, sleep-wake cycles, and the onset of illness.
The BAQ consists of 18 items grouped into four subdomains and is rated on a 7-point Likert scale, ranging from 1 ("not at all true for me") to 7 ("completely true for me").
Total scores are calculated by summing item responses, with higher scores indicating greater body awareness.
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6 months
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Awareness Body Chart (ABC)
Time Frame: 6 months
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The Awareness Body Chart (ABC) is a simple, easy-to-use, and low-cost instrument developed by Danner et al. in 2017.
It demonstrates high internal consistency and test-retest reliability.
The chart consists of schematic anterior and posterior drawings of the human body, divided into 51 regions and 14 body parts based on anatomical structures.
Participants are asked to perceive each body region and indicate their level of awareness by coloring the corresponding areas according to predefined categories.
Higher scores reflect greater body awareness.
The ABC also includes a pain intensity scale ranging from 0 (no pain) to 100 (unbearable pain), and participants are instructed to mark painful areas on the chart.
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6 months
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The Pediatric Quality of Life Inventory (PedsQL)
Time Frame: 6 months
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The Pediatric Quality of Life Inventory (PedsQL) is used to assess general health-related quality of life from both the child's and the parent's perspectives. It evaluates the impact of disease and treatment on physical, emotional, social, and school functioning.The scale consists of 23 items rated on a Likert-type scale, and higher total scores indicate better quality of life. The Turkish version of the PedsQL has demonstrated acceptable validity and reliability. Age-appropriate versions of the questionnaire are used for children aged 8-12 and 13-18 years, with parallel forms containing the same items but adapted language for each age group. Parent-proxy versions are also administered to obtain the parent's perspective. |
6 months
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The Japanese Scoliosis Questionnaire-27 (JSQ-27)
Time Frame: 6 months
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The Japanese Scoliosis Questionnaire-27 (JSQ-27) is used to assess scoliosis-specific quality of life in individuals with adolescent idiopathic scoliosis.
It evaluates a broad range of domains, including pain, discomfort while wearing clothes, concerns about physical appearance, anxiety, and difficulties in daily activities.
The questionnaire consists of 27 items scored on a 5-point scale ranging from 0 ("none") to 4 ("severe").
Total scores are calculated by summing item responses, with higher scores indicating worse scoliosis-specific quality of life.
The JSQ-27 has been validated in individuals with adolescent idiopathic scoliosis, and the Turkish version has demonstrated good validity and internal consistency.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Curve magnitude- Cobb angle method
Time Frame: 6 months
|
Cobb angle method is used as the standard measure of curve severity in adolescent idiopathic scoliosis.
Measurements are obtained from anteroposterior spinal radiographs.
The angle is defined as the intersection between lines drawn along the upper endplate of the most tilted superior vertebra and the lower endplate of the most tilted inferior vertebra.
Values are recorded in degrees.
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6 months
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Axial Trunk Rotation (ATR)
Time Frame: 6 months
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Axial trunk rotation (ATR) is assessed using a scoliometer during the Adam's forward bending test.
Participants are instructed to bend forward from a standing position with knees extended and hands together.
ATR is measured at the level of maximum trunk prominence and recorded in degrees.
The scoliometer is used as an inclinometer to quantify trunk asymmetry and rotational deformity.
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6 months
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Posterior Trunk Symmetry Index
Time Frame: 6 months
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The Posterior Trunk Symmetry Index (POTSI) is used to assess posterior trunk asymmetry.
Standardized photographs are obtained in an upright standing position, and anatomical landmarks such as the C7 spinous process and acromion are marked.
POTSI scores are calculated based on asymmetry indices derived from these landmarks, with higher scores indicating greater asymmetry.
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6 months
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Anterior Trunk Symmetry Index
Time Frame: 6 months
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The Anterior Trunk Symmetry Index (ATSI) is used to assess anterior trunk asymmetry.
Measurements are performed using standardized photographs with landmarks such as the suprasternal notch and acromion identified.
ATSI scores are calculated based on asymmetry indices, with higher scores indicating greater trunk asymmetry.
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6 months
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Exercise Adherence
Time Frame: 6 months
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Exercise adherence is assessed monthly by asking participants to report the percentage of prescribed exercises they complete.
Adherence is expressed as a percentage, and the mean adherence rate over the intervention period is calculated for analysis.
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gözde Yağcı, Prof. Dr., Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HU-SNYaylaci-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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