NCT07500883

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 24, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

scoliosisawarenessquality of liferehabilitationadolescent

Outcome Measures

Primary Outcomes (4)

  • Body Awareness Questionnaire (BAQ)

    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.

    6 months

  • Awareness Body Chart (ABC)

    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.

    6 months

  • The Pediatric Quality of Life Inventory (PedsQL)

    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

  • The Japanese Scoliosis Questionnaire-27 (JSQ-27)

    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.

    6 months

Secondary Outcomes (5)

  • Curve magnitude- Cobb angle method

    6 months

  • Axial Trunk Rotation (ATR)

    6 months

  • Posterior Trunk Symmetry Index

    6 months

  • Anterior Trunk Symmetry Index

    6 months

  • Exercise Adherence

    6 months

Study Arms (2)

Control group

EXPERIMENTAL

Participants in this group will receive only scoliosis-specific exercises. Scientific Exercise Approach to Scoliosis (SEAS) approach will be used.

Other: Scoliosis-specific exercises

BBAT group

ACTIVE COMPARATOR

Participants in this group will receive Basic Body Awareness Therapy (BBAT) in addition to scoliosis-specific exercises (SEAS approach).

Other: Scoliosis-specific exercisesOther: Awareness therapy

Interventions

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 groupControl group

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.

BBAT group

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation, Orthotics and Biomechanics Clinic

Ankara, Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Gözde Yağcı, Prof. Dr.

    Hacettepe University

    STUDY DIRECTOR

Central Study Contacts

SENA NUR YAYLACI, MSc, PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This study is designed as a non-drug clinical trial and a method-comparison study. Participants in SEAS group will receive 40 minutes of scoliosis-specific exercises (SEAS) in the clinic once a week supervised by a physiotherapist. Rest of the week, they will follow a home-based program consisting of 60 minutes SEAS exercises. Participants in the Basic Body Awareness Therapy (BBAT) group will receive 20 minutes of BBAT and 20 minutes of SEAS once a week supervised by a physiotherapist. On the remaining days, they will follow a home-based program consisting of 30 minutes of BBAT and 30 minutes of SEAS exercises. The total duration of the intervention is 6 months, and participants will attend weekly supervised sessions throughout the study period.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 24, 2026

First Posted

March 30, 2026

Study Start

November 12, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations