- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05326256
Trunk Proprioception in Adolescent Idiopathic Scoliosis
Investigation of Trunk Proprioception and the Efficacy of Different Exercise Training on 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.).
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Gaziantep, Turkey
- Hasan Kalyoncu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PSSE Group
Physiotherapy Scoliosis Specific Exercises (PSSE), 45-minute exercise session with the supervisor, twice a week for 12 weeks
|
Barcelona Scoliosis Physical Therapy School (BSPTS) method exercises
|
Experimental: Vestibular Exercise Group
Vestibular exercises to be added to PSSE exercises, 45-minute exercise session with the supervisor, twice a week for 12 weeks
|
Vestibular exercises added to Barcelona Scoliosis Physical Therapy School (BSPTS) exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, after the 12 weeks of exercise training
|
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.
|
Baseline, after the 12 weeks of exercise training
|
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
|
Baseline, after the 12 weeks of exercise training
|
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)
|
Baseline, after the 12 weeks of exercise training
|
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)
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Baseline, after the 12 weeks of exercise training
|
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
|
Baseline, after the 12 weeks of exercise training
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Change of Body Asymmetry
Time Frame: Baseline, after the 12 weeks of exercise training
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Body asymmetry assessment with POTSI (Postural Trunk Symmetry Index)
|
Baseline, after the 12 weeks of exercise training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, after the 12 weeks of exercise training
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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.
|
Baseline, after the 12 weeks of exercise training
|
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.
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Baseline, after the 12 weeks of exercise training
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Change of Angle of Trunk Rotation
Time Frame: Baseline, after the 12 weeks of exercise training
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Angle of trunk rotation is measured with scoliometer on Adam's forward bending test regarding the size of the hump of the trunk.
|
Baseline, after the 12 weeks of exercise training
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Change of Pain
Time Frame: Baseline, after the 12 weeks of exercise training
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Pain assessment with Visual Analogue Scale
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Baseline, after the 12 weeks of exercise training
|
Change of Flexibility
Time Frame: Baseline, after the 12 weeks of exercise training
|
Flexibility assessment with forward and side bending test
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Baseline, after the 12 weeks of exercise training
|
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.
|
Once a week for 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, after the 12 weeks of exercise training
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/008
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
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