Trunk Proprioception in Adolescent Idiopathic Scoliosis

April 18, 2023 updated by: Merve Karatel, Hasan Kalyoncu University

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

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

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Gaziantep, Turkey
        • Hasan Kalyoncu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
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
Change of Body Asymmetry
Time Frame: Baseline, after the 12 weeks of exercise training
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
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.
Baseline, after the 12 weeks of exercise training
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.
Baseline, after the 12 weeks of exercise training
Change of Pain
Time Frame: Baseline, after the 12 weeks of exercise training
Pain assessment with Visual Analogue Scale
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2022

Primary Completion (Actual)

February 2, 2023

Study Completion (Actual)

April 17, 2023

Study Registration Dates

First Submitted

February 24, 2022

First Submitted That Met QC Criteria

April 5, 2022

First Posted (Actual)

April 13, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2022/008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Scoliosis Idiopathic

Clinical Trials on Exercise training- PSSE

3
Subscribe