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Completed

NCT Number: NCT05326256

Trunk Proprioception in Adolescent Idiopathic Scoliosis

Aims of this clinical research:

* To investigate trunk proprioception in all three planes in individuals with adolescent idiopathic scoliosis (AIS), * To investigate the pelvis orientation sense in all three planes in individuals with adolescent idiopathic scoliosis, * To investigate whether trunk proprioception and pelvis orientation sense are improved with Physiotherapy Scoliosis Specific Exercises (PSSE) in AIS, * To investigate whether trunk proprioception and pelvis orientation sense are improved with vestibular exercise training to be added to PSSE exercises in AIS, * Comparison of the effects of different exercise training on trunk proprioception and pelvis orientation sense in AIS * To examine the parameters that may be associated with the improvement of trunk proprioception of different exercise training (health-related quality of life, perception of cosmetic deformity, scoliosis-related clinical features such as Cobb angle, axial trunk rotation, curve type, etc.).

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Key information

Conditions

Scoliosis Idiopathic Behavior Bone Diseases Motor Activity Musculoskeletal Diseases Scoliosis Scoliosis; Adolescence Spinal Curvatures Spinal Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasan Kalyoncu University

Gaziantep, Turkey (Türkiye)

About this study

This clinical study includes examining trunk proprioception and pelvis orientation in all three planes, pain, flexibility, health-related quality of life, perception of cosmetic deformity, dynamic balance, and the effectiveness of different exercise training in individuals aged 10-18 years with a diagnosis of adolescent idiopathic scoliosis and who have PSSE indication.

As the control group; healthy peers with the same characteristics as the exercise groups will be included and they have a negative result of Adam's forward bending test, they do not have any postural disorders.

As a result of the randomization to be applied to the individuals, they will be divided into two groups: PSSE exercise group and vestibular exercise group (vestibular exercises added to PSSE exercises).

Initial assessments will be given to all individuals. Exercise training groups will participate in a 45-minute exercise session with the supervisor, twice a week for 12 weeks. Before exercise training, individuals and their parents will be informed about education and daily life activities.

Apart from the exercises performed under the supervision of a physiotherapist, individuals will be given a home exercise program, and the family and the individual will be asked to keep a diary to evaluate their compliance with the exercise, and the exercise compliance will be evaluated with a phone call every week.

When the exercise training is completed, the training groups will be evaluated as post-training assessments.

In the statistical analysis of data; the values of the control group will be used as normative and will be compared with the data of individuals with scoliosis. The data of the training groups before and after the training program will be compared, and the data of the different exercise groups will be compared with each other.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with adolescent idiopathic scoliosis,
  • Aged 10-18,
  • Have Physiotherapy Scoliosis Specific Exercises (PSSE) indications,
  • Individuals and her/his parents volunteered to participate in the study.

Exclusion criteria

  • Any contraindication that will prevent the individual from participating to exercise training,
  • Have had spinal surgery before,
  • Have any mental problems,
  • The fact that scoliosis is not idiopathic but has arisen for different reasons (neurological, congenital, etc.),
  • The apex of the curve is thoracal-6 vertebrae and above,
  • Any neurological, psychiatric, muscular, rheumatic, renal, cardiovascular, pulmonary, tumoral, or orthopedic disease.

Treatment and study plan

Exercise training- PSSE

Other

Barcelona Scoliosis Physical Therapy School (BSPTS) method exercises

Exercise training- PSSE with vestibular exercises

Other

Vestibular exercises added to Barcelona Scoliosis Physical Therapy School (BSPTS) exercises

Primary outcomes

  1. Change of Trunk Proprioception

    Time frame: Baseline, after the 12 weeks of exercise training

    Thoracic position sense is measured by active angle reproduction using GyKo (Microgate, Bolzano, Italy) inertial system. The system component is located on the trunk at the level of C7-T1 vertebrae. The individual to be measured is standing, for example, the individual to flexion the trunk to 30 degrees and is shown to target angle. Then, the individual is asked to close his eyes and come to the target angle actively. The measurement is repeated 3 times. All data are read from the screen.

  2. Change of Pelvis Orientation Sense

    Time frame: Baseline, after the 12 weeks of exercise training

    Pelvis orientation sense is measured by active angle reproduction using GyKo (Microgate, Bolzano, Italy) inertial system. The system component is located on the lumbar area at the level of the S1 vertebrae. The individual to be measured is standing, performs the anterior-posterior pelvic tilt motion in her/his pelvis, and is shown to target angle. Then, the individual is asked to close his eyes and come to the target angle actively. The measurement is repeated 3 times. All data are read from the screen.

  3. Change of Dynamic balance, spatial orientation

    Time frame: Baseline, after the 12 weeks of exercise training

    Assement of dynamic balance with Fukuda-Utenberger stepping test

  4. Change of Cosmetic Deformity Perception

    Time frame: Baseline, after the 12 weeks of exercise training

    Perception of cosmetic deformity assessment with Walter Reed Visual Evaluation Scale and Turkish version of The Spinal Appearance Questionnaire (SAQ)

  5. Change of Cosmetic Deformity Perception according to Individual, Parent and Physiotherapist

    Time frame: Baseline, after the 12 weeks of exercise training

    Perception of cosmetic deformity assessment with Turkish version of The Spinal Appearance Questionnaire (SAQ)

  6. Change of Health-Related Quality of Life

    Time frame: Baseline, after the 12 weeks of exercise training

    Health-Related Quality of Life Assessment with Turkish version of Scoliosis Research Society-22 (SRS-22) Questionnaire

  7. Change of Body Asymmetry

    Time frame: Baseline, after the 12 weeks of exercise training

    Body asymmetry assessment with POTSI (Postural Trunk Symmetry Index)

Secondary outcomes

  1. Enroll of the Cobb Angle

    Time frame: Baseline, after the 12 weeks of exercise training

    The Cobb angle is measured on postero-anterior full spine radiographs as the standard method of quantifying the amount of lateral deviation of the spine.

  2. Enroll of the Risser sign

    Time frame: Baseline, after the 12 weeks of exercise training

    Risser sign is observed that the state of ossification of the iliac apophysis on radiographs as the standard method of quantifying the skeletal maturity.

  3. Enroll of the clinical features of scoliosis

    Time frame: Baseline, after the 12 weeks of exercise training

    The classification of Lenke, SRS (Scoliosis Research Society), and BSPTS (Barcelona Scoliosis Physical Therapy School) are determined according to individual's radiographs, results of Adam's forward bending test, and orientation of the trunk position regarding pelvis.

  4. Change of Angle of Trunk Rotation

    Time frame: Baseline, after the 12 weeks of exercise training

    Angle of trunk rotation is measured with scoliometer on Adam's forward bending test regarding the size of the hump of the trunk.

  5. Change of Pain

    Time frame: Baseline, after the 12 weeks of exercise training

    Pain assessment with Visual Analogue Scale

  6. Change of Flexibility

    Time frame: Baseline, after the 12 weeks of exercise training

    Flexibility assessment with forward and side bending test

  7. Evaluation of exercise training compliance

    Time frame: Once a week for 12 weeks

    The compliance of the home exercise program is followed by weekly phone calls with the individual and their parents. At the end of the research, the amount of exercise compliance of the individuals will be determined according to the calculation of recommended and performing exercises.

Other outcomes

  1. Change of Quality of Life according to brace- The Brace Questionnaire

    Time frame: Baseline, after the 12 weeks of exercise training

    In individuals using brace:Turkish version of the Brace Questionnaire (BrQ) is used. The minimum score is 20 and the maximum score is 100 and also, high scores indicate a better quality of life in this scale.

Sponsors and collaborators

Lead sponsor

Hasan Kalyoncu University

Other

Registry information

Official study title

Investigation of Trunk Proprioception and the Efficacy of Different Exercise Training on Trunk Proprioception in Adolescent Idiopathic Scoliosis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 13, 2022
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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