NCT06855030

Brief Summary

Adolescent idiopathic scoliosis (AIS) is a complex deformity of the spine, and its cause remains unknown. AIS can have negative physical, psychological, and social effects on an individual's health. There are two main treatment options for AIS: surgical and conservative approaches, including observation, exercise, and bracing. Scoliosis-specific exercises (SSE) refer to globally recognized, evidence-based exercise approaches. In this study, the Scientific Exercise Approach to Scoliosis (SEAS), one of the SSE methods, will be used. SEAS consists of individualized active self-correction exercises combined with functional movements. Additionally, the Basic Body Awareness Therapy (BBAT) method will also be applied. BBAT is a body-focused, comprehensive approach that incorporates slow, rhythmic movements and breath control. Both groups will attend supervised sessions in the clinic once a week, and home exercises will be assigned for the remaining days. Participants in the SEAS group will receive only SEAS treatment, while those in the BBAT group will receive both SEAS and additional BBAT exercises. The goal of this clinical study is to investigate the effects of BBAT in addition to a rehabilitation program including SSE, on posture, spatial orientation, trunk proprioception, scoliosis-specific parameters, quality of life, and body in adolescents with IS aged between 10 and 17 years. The research hypotheses for this study are as follows: H1: Basic Body Awareness Therapy has an effect on posture in adolescents with idiopathic scoliosis. H2: Basic Body Awareness Therapy has an effect on spatial orientation in adolescents with idiopathic scoliosis. H3: Basic Body Awareness Therapy has an effect on trunk proprioception in adolescents with idiopathic scoliosis. H4: Basic Body Awareness Therapy has an effect on scoliosis-specific clinical parameters in adolescents with idiopathic scoliosis. H5: Basic Body Awareness Therapy has an effect on both general and scoliosis-specific quality of life in adolescents with idiopathic scoliosis. H6: Basic Body Awareness Therapy has an effect on body awareness in adolescents with idiopathic scoliosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet 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

First Submitted

Initial submission to the registry

February 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

April 15, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

February 24, 2025

Last Update Submit

April 14, 2025

Conditions

Keywords

scoliosisawarenessproprioceptionPhysiotherapy

Outcome Measures

Primary Outcomes (8)

  • Trunk Proprioception

    To evaluate trunk proprioception, three tests will be used. Measurements will be repeated three times for each test, and the average value will be calculated. The obtained angle will be recorded in degrees and referred to as the error angle.

    16 weeks

  • Posture ( perception of deformity severity)

    For posture assessment, the Spinal Appearance Questionnaire will be used first. It will be completed by the participant, their parent, and the physiotherapist. In this way, the perception of deformity severity will be measured. It is a valid measure for assessing self-image in adolescents with idiopathic scoliosis. This questionnaire includes 11 standardized drawings that represent different severity levels of spinal deformity perception. Additionally, it consists of 22 Likert-scale questions reflecting the patient's impressions and expectations regarding their appearance. Patients select one of five response options for each drawing, with 1 indicating the best and 5 indicating the worst perception. The total score is the sum of all responses, and a higher score indicates a more severe deformity.

    16 weeks

  • Postural Symmetry for Anterior Trunk

    Anterior Trunk Symmetry Index (ATSI) is another objective method used to assess postural asymmetry in the anterior trunk. Similar to POTSI, ATSI calculations are based on photographs taken in the optimal standing posture. Although reference values for ATSI are available for different age groups, a definitive normal value has not been established. Higher ATSI values indicate increased asymmetry.

    16 weeks

  • Postural Symmetry for Posterior Trunk

    Posterior Trunk Symmetry Index (POTSI) is an objective and comprehensive method used to evaluate an individual's postural asymmetry. For the calculation of POTSI, photographs will be taken in the optimal standing posture for assessment. The ideal value of the POTSI index is 0, indicating that the trunk is symmetric, while values above 0 represent asymmetry.

    16 weeks

  • Scoliosis-specific parameters

    For the assessment of scoliosis parameters, curve severity and trunk rotation will be measured. The Cobb angle method, considered the gold standard, will be used to assess the severity of the curve, measured from the individual's antero-posterior X-ray image. The Cobb angle is defined as the angle between the superior endplate of the uppermost vertebra and the inferior endplate of the lowermost vertebra involved in the curve in the coronal plane. A Cobb angle greater than 10° is required for a diagnosis of AIS. The scoliometer will be use to assess axial trunk rotation. It is a type of inclinometer that measures the symmetry of both sides of the trunk and records it in degrees. The value of 0 observed on the scoliometer indicates that the trunk is symmetric, while values above 0 indicate asymmetry. A 5° threshold on the scoliometer is considered significant, with values above it being regarded as meaningful.

    16 weeks

  • Spatial Orientation

    The Fukuda stepping test will be used to assess spatial orientation. Measurements will be taken between the marked points at the start and end of the test, with displacement distance recorded in centimeters and displacement angle in degrees. A decrease in angle or distance will be considered an improvement. Although there are no reference values for individuals with AIS, it has been emphasized in the literature that this test is effective in demonstrating proprioceptive deficits in this group. This test will provide information about individuals' dynamic proprioception.

    16 weeks

  • Body awareness (Awareness of body responses)

    The Body Awareness Questionnaire (BAQ) is used to assess individuals' body awareness by exploring body responses, predictions about bodily processes, the disease process, and the sleep-wake cycle. It consists of 18 items and 4 subgroups in a Likert scale format. Participants rate statements from 1 (Not true for me) to 7 (Completely true for me). The total score is calculated by summing the ratings, and an increase in the score indicates improved body awareness.

    16 weeks

  • Body awareness and perception

    The Awareness Body Chart (ABC) is another tool used to assess body awareness. It includes simple front and back drawings of male and female bodies, divided into 51 regions and 14 body parts. Participants are asked to color these body parts according to awareness levels represented by specific colors. The total score is calculated by summing the points corresponding to the colors, and an increase in the score indicates an improvement in awareness.

    16 weeks

Secondary Outcomes (3)

  • Quality of life related to scoliosis

    16 weeks

  • General quality of life

    16 weeks

  • Evaluation of treatment compliance

    16 weeks

Study Arms (2)

SEAS group

EXPERIMENTAL

Individuals including this group will only be applied scoliosis specific exercises for treatment. Scientific Exercise Approach to Scoliosis (SEAS) approach will be used. These individuals will be followed in the clinic once a week for 60 minutes. The rest of the week, they will complete their program at home for 40 minutes.

Other: Scoliosis Specific Exercise

BBAT group

ACTIVE COMPARATOR

Individuals in this group will receive Basic Body Awareness Therapy (BBAT) in addition to scoliosis-specific exercises. Individuals in the BBAT group will be seen in the clinic once a week and will receive 30 minutes of BBAT in addition to 30 minutes of SEAS. They will perform their exercises at home for a total of 40 minutes, consisting of 20 minutes of BBAT and 20 minutes of SEAS. Total treatment duration will be the same for each group.

Other: Scoliosis Specific ExerciseOther: Basic Body Awareness Therapy

Interventions

In the first session, the individual and their family will learn about AIS, the specific curvature, and the treatment process. They will also be taught correct posture and active self-correction, which means finding the best alignment in three planes. Once the individual becomes confident in their self-correction, they will start exercises. In the SEAS method, exercises begin in a sitting position, and as the individual improves, the exercises will be made more challenging and suited to their level. The rehabilitation protocol includes exercises in standing, squatting, single-leg stance, and on the floor. In each session, previous exercises will be reviewed, and new ones will be added. Individuals will be reminded to practice active self-correction during exercises and daily activities. In literature, there is no fixed protocol for exercise duration and frequency, but it is recommended to do exercises 2-3 times a week for 45 minutes or 20 minutes daily.

Also known as: SEAS group
BBAT groupSEAS group

Body awareness movements will be performed in lying, sitting, and standing positions. Then, they will be varied by incorporating walking, running, and voice use. The patient will be asked to perform these movements with a specific rhythm and coordination. BBAT aims to enhance body awareness and create a more realistic body image by normalizing posture, balance, and muscle tension. The training process will involve gradually increasing awareness of the relationship with the floor, the vertical axis, centering, breathing, and flow. During this therapy process, the goal is to improve the individual's awareness of themselves and their surroundings, helping them adopt the "here and now" experience and later apply it in daily life. At the end of each session, time will be given for the patient to respond to their experience and express their thoughts. There is variability in the application duration in the literature.

Also known as: BBAT group
BBAT group

Eligibility Criteria

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

You may qualify if:

  • Being diagnosed with adolescent idiopathic scoliosis
  • Being between the ages of 10 and 17
  • Having scoliosis of 15° or greater
  • Not having received previous treatment for scoliosis and not receiving any other treatment during this study
  • Risser stage 0-4
  • Willing to participate in the study

You may not qualify if:

  • Having any spinal/bone deformity in addition to scoliosis (such as hyperkyphosis, pectus, etc.)
  • Wearing a brace
  • Having congenital scoliosis
  • Having any rheumatological, neuromuscular, neurological, cardiovascular, or pulmonary pathology
  • Having a regular history or habit of physical activity
  • Having undergone scoliosis surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Physiotherapy and Rehabilitation, Hacettepe, Ankara, 06000

Ankara, Turkey (Türkiye)

Location

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

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Gözde Yağcı, Prof. Dr.

    Hacettepe University

    STUDY DIRECTOR
  • Sena Yaylacı, MSc, PT

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sena Nur YAYLACI, MSc, PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant's parents.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: In this study, treatment duration is planned to be 16 weeks. The Scientific Exercises Approach to Scoliosis (SEAS) group will receive 60 minutes of SEAS in the clinic once a week, along with a 40-minute home exercise assignment. The other group will receive 30 minutes of SEAS and 30 minutes of Basic Body Awareness Therapy (BBAT) in the clinic onca a week, and both SEAS and BBAT exercises for 20 minutes each as home assignments. Non-drug clinical research and method comparison clinical research.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 24, 2025

First Posted

March 3, 2025

Study Start

April 1, 2025

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

April 15, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations