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Trunk Proprioception in Adolescent Idiopathic Scoliosis

Primary Purpose

Scoliosis Idiopathic, Scoliosis; Adolescence

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise training- PSSE
Exercise training- PSSE with vestibular exercises
Sponsored by
Hasan Kalyoncu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis Idiopathic focused on measuring scoliosis, adolescent, proprioception, exercise

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hasan Kalyoncu University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PSSE Group

Vestibular Exercise Group

Arm Description

Physiotherapy Scoliosis Specific Exercises (PSSE), 45-minute exercise session with the supervisor, twice a week for 12 weeks

Vestibular exercises to be added to PSSE exercises, 45-minute exercise session with the supervisor, twice a week for 12 weeks

Outcomes

Primary Outcome Measures

Change of Trunk Proprioception
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.
Change of Pelvis Orientation Sense
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.
Change of Dynamic balance, spatial orientation
Assement of dynamic balance with Fukuda-Utenberger stepping test
Change of Cosmetic Deformity Perception
Perception of cosmetic deformity assessment with Walter Reed Visual Evaluation Scale and Turkish version of The Spinal Appearance Questionnaire (SAQ)
Change of Cosmetic Deformity Perception according to Individual, Parent and Physiotherapist
Perception of cosmetic deformity assessment with Turkish version of The Spinal Appearance Questionnaire (SAQ)
Change of Health-Related Quality of Life
Health-Related Quality of Life Assessment with Turkish version of Scoliosis Research Society-22 (SRS-22) Questionnaire
Change of Body Asymmetry
Body asymmetry assessment with POTSI (Postural Trunk Symmetry Index)

Secondary Outcome Measures

Enroll of the Cobb Angle
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.
Enroll of the Risser sign
Risser sign is observed that the state of ossification of the iliac apophysis on radiographs as the standard method of quantifying the skeletal maturity.
Enroll of the clinical features of scoliosis
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.
Change of Angle of Trunk Rotation
Angle of trunk rotation is measured with scoliometer on Adam's forward bending test regarding the size of the hump of the trunk.
Change of Pain
Pain assessment with Visual Analogue Scale
Change of Flexibility
Flexibility assessment with forward and side bending test
Evaluation of exercise training compliance
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.

Full Information

First Posted
February 24, 2022
Last Updated
April 18, 2023
Sponsor
Hasan Kalyoncu University
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1. Study Identification

Unique Protocol Identification Number
NCT05326256
Brief Title
Trunk Proprioception in Adolescent Idiopathic Scoliosis
Official Title
Investigation of Trunk Proprioception and the Efficacy of Different Exercise Training on Trunk Proprioception in Adolescent Idiopathic Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
February 2, 2023 (Actual)
Study Completion Date
April 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic, Scoliosis; Adolescence
Keywords
scoliosis, adolescent, proprioception, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants in the training groups and the statistical assessor will not be informed about which group the individuals belong to.
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PSSE Group
Arm Type
Experimental
Arm Description
Physiotherapy Scoliosis Specific Exercises (PSSE), 45-minute exercise session with the supervisor, twice a week for 12 weeks
Arm Title
Vestibular Exercise Group
Arm Type
Experimental
Arm Description
Vestibular exercises to be added to PSSE exercises, 45-minute exercise session with the supervisor, twice a week for 12 weeks
Intervention Type
Other
Intervention Name(s)
Exercise training- PSSE
Intervention Description
Barcelona Scoliosis Physical Therapy School (BSPTS) method exercises
Intervention Type
Other
Intervention Name(s)
Exercise training- PSSE with vestibular exercises
Intervention Description
Vestibular exercises added to Barcelona Scoliosis Physical Therapy School (BSPTS) exercises
Primary Outcome Measure Information:
Title
Change of Trunk Proprioception
Description
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.
Time Frame
Baseline, after the 12 weeks of exercise training
Title
Change of Pelvis Orientation Sense
Description
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.
Time Frame
Baseline, after the 12 weeks of exercise training
Title
Change of Dynamic balance, spatial orientation
Description
Assement of dynamic balance with Fukuda-Utenberger stepping test
Time Frame
Baseline, after the 12 weeks of exercise training
Title
Change of Cosmetic Deformity Perception
Description
Perception of cosmetic deformity assessment with Walter Reed Visual Evaluation Scale and Turkish version of The Spinal Appearance Questionnaire (SAQ)
Time Frame
Baseline, after the 12 weeks of exercise training
Title
Change of Cosmetic Deformity Perception according to Individual, Parent and Physiotherapist
Description
Perception of cosmetic deformity assessment with Turkish version of The Spinal Appearance Questionnaire (SAQ)
Time Frame
Baseline, after the 12 weeks of exercise training
Title
Change of Health-Related Quality of Life
Description
Health-Related Quality of Life Assessment with Turkish version of Scoliosis Research Society-22 (SRS-22) Questionnaire
Time Frame
Baseline, after the 12 weeks of exercise training
Title
Change of Body Asymmetry
Description
Body asymmetry assessment with POTSI (Postural Trunk Symmetry Index)
Time Frame
Baseline, after the 12 weeks of exercise training
Secondary Outcome Measure Information:
Title
Enroll of the Cobb Angle
Description
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.
Time Frame
Baseline, after the 12 weeks of exercise training
Title
Enroll of the Risser sign
Description
Risser sign is observed that the state of ossification of the iliac apophysis on radiographs as the standard method of quantifying the skeletal maturity.
Time Frame
Baseline, after the 12 weeks of exercise training
Title
Enroll of the clinical features of scoliosis
Description
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.
Time Frame
Baseline, after the 12 weeks of exercise training
Title
Change of Angle of Trunk Rotation
Description
Angle of trunk rotation is measured with scoliometer on Adam's forward bending test regarding the size of the hump of the trunk.
Time Frame
Baseline, after the 12 weeks of exercise training
Title
Change of Pain
Description
Pain assessment with Visual Analogue Scale
Time Frame
Baseline, after the 12 weeks of exercise training
Title
Change of Flexibility
Description
Flexibility assessment with forward and side bending test
Time Frame
Baseline, after the 12 weeks of exercise training
Title
Evaluation of exercise training compliance
Description
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.
Time Frame
Once a week for 12 weeks
Other Pre-specified Outcome Measures:
Title
Change of Quality of Life according to brace- The Brace Questionnaire
Description
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.
Time Frame
Baseline, after the 12 weeks of exercise training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Hasan Kalyoncu University
City
Gaziantep
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Trunk Proprioception in Adolescent Idiopathic Scoliosis

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