Trunk Proprioception in Adolescent Idiopathic Scoliosis

Sponsor
Hasan Kalyoncu University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05326256
Collaborator
(none)
30
1
2
12.9
2.3

Study Details

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.).

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise training- PSSE
  • Other: Exercise training- PSSE with vestibular exercises
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Participants in the training groups and the statistical assessor will not be informed about which group the individuals belong to.
Primary Purpose:
Treatment
Official Title:
Investigation of Trunk Proprioception and the Efficacy of Different Exercise Training on Trunk Proprioception in Adolescent Idiopathic Scoliosis
Actual Study Start Date :
Feb 2, 2022
Anticipated Primary Completion Date :
Feb 2, 2023
Anticipated Study Completion Date :
Mar 2, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: PSSE Group

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

Other: Exercise training- PSSE
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

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

Outcome Measures

Primary Outcome Measures

  1. Change of Trunk Proprioception [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 [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 [Baseline, after the 12 weeks of exercise training]

    Assement of dynamic balance with Fukuda-Utenberger stepping test

  4. Change of Cosmetic Deformity Perception [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 [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 [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 [Baseline, after the 12 weeks of exercise training]

    Body asymmetry assessment with POTSI (Postural Trunk Symmetry Index)

Secondary Outcome Measures

  1. Enroll of the Cobb Angle [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 [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 [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 [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 [Baseline, after the 12 weeks of exercise training]

    Pain assessment with Visual Analogue Scale

  6. Change of Flexibility [Baseline, after the 12 weeks of exercise training]

    Flexibility assessment with forward and side bending test

  7. Evaluation of exercise training compliance [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hasan Kalyoncu University Gaziantep Turkey

Sponsors and Collaborators

  • Hasan Kalyoncu University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Merve Karatel, Principal Investigator, Hasan Kalyoncu University
ClinicalTrials.gov Identifier:
NCT05326256
Other Study ID Numbers:
  • 2022/008
First Posted:
Apr 13, 2022
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Merve Karatel, Principal Investigator, Hasan Kalyoncu University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2022