Active Video Game-Based Exercise Training and Stability Training After AIS Surgery
NCT Number: NCT06498232
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adolescent Idiopathic Scoliosis|Spinal Fusion
Interventions: OTHER: Active Video Based Exercises|OTHER: Stabilization and Strengthening Exercises|OTHER: Waiting List-Spine protection principles training
Sponsor: Istanbul University - Cerrahpasa (IUC)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 51
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-15
Completion Date: 2026-03-30
Locations: Istanbul University-Cerrahpasa, Istanbul, Turkey

Summary:
The purpose of this clinical trial is to investigate the effects of "Active Video-Based Exercises (AVTE) on postural control and balance in comparison with stabilization exercises is (AIS) after Posterior Spinal Fusion (PSF) surgery. Fifty-one patients with AIS after PSF surgery will be randomly divided into groups as Group I-AVTE Group, Group II-Exercise Group, Group III-Control Group, and a 12-week program will be applied. Evaluations will be performed at baseline, 12 and 24 weeks. The primary evaluations will be postural stability and balance; secondary evaluations will be pain, trunk muscle strength, mobility, endurance, core stabilization, function, quality of life, and satisfaction.

Primary Outcome Measures: Postural Stability Test, The postural stability of the participants will be evaluated with the "Postural Stability Test" on a static surface via the postural stability assessment system., 12 weeks, 6 months|Stability Limits Test, The postural stability of the participants will be evaluated with the "Stability Limits Test" on a static surface via the postural stability assessment system., 12 weeks, 6 months|Sensory Integration Test, The static and dynamic balance of the participants will be evaluated with the "Sensory Integration Test" via the postural stability assessment system., 12 weeks, 6 months|One-Legged Posture Test, The static and dynamic balance of the participants will be evaluated with the "One-Legged Posture Test" via the postural stability assessment system., 12 weeks, 6 months
Secondary Outcome Measures: Spine Pain, Numerical Pain Scale, which is frequently preferred by clinicians in determining and monitoring pain severity, will be used in pain assessment because it is easily applicable, can be done in a short time, can be repeated and the test is easy to understand. In this scale, patients will be asked to score the severity of their pain between 0 and 10, where 0 means "no pain" and 10 means "unbearable pain.", 12 weeks, 6 months|The forward bending test, The forward bending test will be used to evaluate trunk flexibility in the sagittal plane. The patient is asked to sit tall on a hard surface with both knees extended, feet 15 cm apart from each other, leaning on a 25 cm long step, and reach the feet with his hands while his elbows are extended without flexing his knees. The distance between the third finger and the foot will be measured with a ruler and recorded as "cm"., 12 weeks, 6 months|The side bending test, The side bending test will be used to evaluate trunk flexibility in the frontal plane. During the test, the patient will be asked to lean to the right and left side respectively, without leaving his back to the wall. The distance between the third finger and the ground will be measured with the help of a 50 cm long rigid ruler and recorded in "cm".

In all evaluation sessions, each measurement will be repeated three times by the same physiotherapist, and the average of the measurements., 12 weeks, 6 months|Trunk Isometric Muscle Strength, Evaluation of trunk flexion, extension, and right-left lateral flexion isometric muscle strength will be performed with a manual muscle testing device, which is an objective, valid, and reliable method. Trunk flexion evaluation will be performed in the 30-degree supine position, trunk extension in the prone position, and lateral flexion in the sitting position., 12 weeks, 6 months|Lateral Bridge Test, One of the three trunk muscle endurance tests created by McGill, the lateral bridge test will be evaluated. Before the test, the required test position will be explained to the participant and he/she will be asked to try the appropriate position., 12 weeks, 6 months|Trunk Extension Test, One of the three trunk muscle endurance tests created by McGill, the trunk extension test will be evaluated. Before the test, the required test position will be explained to the participant and he/she will be asked to try the appropriate position., 12 weeks, 6 months|Trunk Flexion Test, One of the three trunk muscle endurance tests created by McGill, consisting of the trunk flexion test, will be evaluated. Before the test, the required test position will be explained to the participant and he/she will be asked to try the appropriate position., 12 weeks, 6 months|Core Stabilization, Core stabilization evaluation will be performed in supine and prone positions with the Stabilizer Pressure Feedback Unit. The "Shermann core stabilization test," which is valid and reliable in the supine position, will be used. This test consists of 5 increasingly difficult levels. The measurement will be repeated 3 times with 30-second rest periods, and the maximum value will be recorded., 12 weeks, 6 months|Sock Test, Valid and reliable sock test, will be used to evaluate the functional level of the cases.

In the sock test, the patient will be asked to sit in a high place so that his feet do not touch the ground, and to lift one leg and put on the socks with both hands without his feet touching the chair. After testing each leg once, the patient will be given a score between 0-3. Lower values in the scoring will represent better performance., 12 weeks, 6 months|Pick-up Test, Valid and reliable pick-up test will be used to evaluate the functional level of the cases.

In the picking test, the patient will be asked to pick up a piece of paper from the floor and the patient's performance will be evaluated using a 4-point ordinal scale. Lower values in the scoring will represent better performance., 12 weeks, 6 months|Pebble Test, Valid and reliable pebble test will be used to evaluate the functional level of the cases.

In the pebble test, the participant will be asked to lift a 5 kg weight from the ground to the table (76 cm) and bring it back to the ground, and the number of lifts will be recorded., 12 weeks, 6 months|Child Physical Activity Questionnaire (8-14 years old), The physical activity levels of the participants will be evaluated with the Child Physical Activity Questionnaire (8-14 years old), which provides valuable data and is valid and reliable in evaluating physical activity in healthy adolescents. Participants' high scores in the survey evaluation indicate that their physical activity levels have increased., 12 weeks, 6 months|Adolescent Physical Activity Questionnaire (14-20 years old), The physical activity levels of the participants will be evaluated with the Adolescent Physical Activity Questionnaire (14-20 years old) which provides valuable data and is valid and reliable in evaluating physical activity in healthy adolescents. Participants' high scores in the survey evaluation indicate that their physical activity levels have increased., 12 weeks, 6 months|Pedometer, The physical activity levels of the participants will be evaluated with the pedometer, which provides objective data and is valid and reliable in evaluating physical activity in healthy adolescents. Participants will be instructed to wear the pedometer on their right or left hip side (non-dominant side) over their clothing or belt. The number of steps taken by participants during a week will be recorded. Participants' increase in the number of steps on the pedometer indicate that their physical activity levels have increased., 12 weeks, 6 months|Scoliosis-Specific Quality of Life, Scoliosis Research Society Questionnaire -30 (SRS-30) is a simple and practical quality of life questionnaire that is most frequently used to evaluate the quality of life in scoliosis patients and has been translated into our language and has validity and reliability, created specifically for individuals with scoliosis. Each question is scored from 1 (worst) to 5 (best) in the survey, which evaluates five domains: function, pain, self-image, mental health (five questions each), and treatment satisfaction (two questions)., 12 weeks, 6 months|Treatment Satisfaction, Participants' satisfaction with the treatment will be evaluated with the Global Rating of Change (GRC). GRC is used quite frequently, especially in the field of the musculoskeletal system. This scale is designed to determine the extent of improvement or deterioration of the patient over time. It also indicates the effect of an intervention or the clinical course of a condition. In the GRC scale, the patient is asked to indicate the difference between their current health status and their health status before a specific point in time. The questions asked, the number of points on the scale, and the labels assigned to the scale points may vary. A 7-point scale (-3: much worse, -2: worse, -1: slightly worse, 0: the same, 1: slightly better, 2: quite better, 3: much better) will be used in our study., 12 weeks, 6 months