Effectiveness of Rehabilitation With Technology-Based Systems in Adolescent Idiopathic Scoliosis
NCT Number: NCT06469021
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Scoliosis; Adolescence
Interventions: OTHER: Conservative Approach|OTHER: Rehabilitative Game Therapy
Sponsor: hande tunc
Sex: FEMALE
Age: CHILD
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-06
Locations: Istanbul Medipol University, Istanbul, Turkey

Summary:
The aim of this study was to investigate the effect of technology-based exercises on treatment success in adolescents with idiopathic scoliosis.

Within the scope of the study, thirty patients with AIS will be randomly allocated to two groups. The control group will apply a program with conventional approaches consisting of a combination of structured three-dimensional scoliosis exercises, core stabilization and balance exercises. Patients in the intervention group will perform structured three-dimensional scoliosis exercises, core stabilization and balance exercises similarly to the control group. However, patients in the intervention group will perform core stabilization and balance exercises with virtual reality games for twenty-four weeks. Patients' Cobb angle, Pediatric Berg Balance Scale (balance), Posterior Trunk Asymmetry Index (POTSI) (cosmetic), Walter Reed Visual Assessment Scale (WRVAS)(cosmetic), System Usability Scale (system usability) and Physical Activity Participation Motivation Scale (PAPMS) (motivation) parameters will be assess at the beginning of treatment, third and six month.

Primary Outcome Measures: Cobb Angle, In the treatment of scoliosis, the Cobb angle is considered the most important outcome for the evaluation of treatment efficacy. The Cobb angle is measured from anteroposterior graphs taken during standing. Measurements will be taken by a blinded assessor via SurgiMap web application to eliminate individual errors. Measurements will be made from radiographs taken at the beginning and sixth month of treatment because of the radiation exposure., At the beginning of the study and sixth month of the study|Posterior Trunk Symmetry Index (POTSI), POTSI is a method that makes it possible to evaluate the trunk asymmetry of an individual with AIS from the posterior and objectively scores the cosmetic effect. It is based on certain calculations performed on a posterior photograph of the individual. The score calculated in POTSI analysis consists of the sum of 6 indices. In order to prevent possible calculation errors and standardize the measurements, the cases will be evaluated with a mobile application named POTSIApp., At the beginning of the study, third month and sixth month of the study|Walter Reed Visuel Assessment Scale (WRVAS), WRVAS is a scale that scores the severity of curvature by focusing on the person's perception of posture. It is divided into 7 parameters including body curvature, rib prominence, lumbar prominence, head-rib-pelvis positional relationship, head-pelvis relationship, shoulder level and scapula rotation. A high score means that the perceived deformity is high., At the beginning of the study, third month and sixth month of the study
Secondary Outcome Measures: The Pediatric Balance Scale (PBBS), The Pediatric Balance Scale is a 14-question test that functionally assesses balance. It is a functional assessment that includes many maneuvers that will challenge balance based on daily activities. High scores indicate good balance performance., At the beginning of the study, third month and sixth month of the study|The Physical Activity Participation Motivation Scale (PAPMS), The Physical Activity Participation Motivation Scale (PAPMS) is a Likert-type scale used to assess the motivation levels of individuals for physical activity. The scale consists of 3 sub-dimensions (individual reasons, environmental reasons and lack of reason dimension) and a total of 16 questions in 5-point Likert type. High values are associated with high motivation level., At the beginning of the study, third month and sixth month of the study|The System Usability Scale (SUS), The System Usability Scale (SUS) is a scale used to evaluate usability. It is a 10-item Likert-type scale that can be used individually and allows general usability evaluation. High scores on the scale indicate that systems are usable., At the beginning of the study, third month and sixth month of the study|Angle of Trunk Rotation, The scoliometer is a specially designed inclinometer that is easy to use, inexpensive, reliable and practical for the clinical assessment of scoliosis. inexpensive, reliable and practical for the clinical assessment of scoliosis. Inside the scoliometer is a metal sphere that moves in the water bed and higher degrees indicates increased degree of body rotation. In the forward bending position, the scoliometer is placed vertically on the axial axis of the spine perpendicular to the spinous process of the vertebra and measured, At the beginning of the study, third month and sixth month of the study