Trunk Proprioception in Adolescent Idiopathic Scoliosis

Scoliosis Idiopathic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05326256
• Other study ID #: 2022/008
• Status: Completed
• Phase: N/A
• Start date: February 2, 2022
• Est. completion date: April 17, 2023

Study information

• Verified date: April 2023
• Source: Hasan Kalyoncu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 17, 2023
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic
• Scoliosis; Adolescence

Intervention

Other:
• Exercise training- PSSE
Barcelona Scoliosis Physical Therapy School (BSPTS) method exercises
• Exercise training- PSSE with vestibular exercises
Vestibular exercises added to Barcelona Scoliosis Physical Therapy School (BSPTS) exercises

Locations

Country	Name	City	State
Turkey	Hasan Kalyoncu University	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of Quality of Life according to brace- The Brace Questionnaire	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
Primary	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.	Baseline, after the 12 weeks of exercise training
Primary	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.	Baseline, after the 12 weeks of exercise training
Primary	Change of Dynamic balance, spatial orientation	Assement of dynamic balance with Fukuda-Utenberger stepping test	Baseline, after the 12 weeks of exercise training
Primary	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)	Baseline, after the 12 weeks of exercise training
Primary	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)	Baseline, after the 12 weeks of exercise training
Primary	Change of Health-Related Quality of Life	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
Primary	Change of Body Asymmetry	Body asymmetry assessment with POTSI (Postural Trunk Symmetry Index)	Baseline, after the 12 weeks of exercise training
Secondary	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.	Baseline, after the 12 weeks of exercise training
Secondary	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.	Baseline, after the 12 weeks of exercise training
Secondary	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.	Baseline, after the 12 weeks of exercise training
Secondary	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.	Baseline, after the 12 weeks of exercise training
Secondary	Change of Pain	Pain assessment with Visual Analogue Scale	Baseline, after the 12 weeks of exercise training
Secondary	Change of Flexibility	Flexibility assessment with forward and side bending test	Baseline, after the 12 weeks of exercise training
Secondary	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.	Once a week for 12 weeks