Active Video Game-Based Exercise Training and Stability Training After AIS Surgery
- Conditions
- Adolescent Idiopathic ScoliosisSpinal Fusion
- Interventions
- Other: Stabilization and Strengthening ExercisesOther: Active Video Based ExercisesOther: Waiting List-Spine protection principles training
- Registration Number
- NCT06498232
- Lead Sponsor
- Istanbul University - Cerrahpasa (IUC)
- Brief 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.
- Detailed Description
Posterior Spinal Fusion (PSF) is considered the gold standard in the surgical treatment of Adolescent Idiopathic Scoliosis (AIS) as it provides successful results in terms of deformity correction. However, it has been emphasized in many studies that postoperative rehabilitation should be planned to reduce pain and movement limitations of individuals after surgery and to increase their activity and participation levels. It is stated that postoperative rehabilitation programs should especially include stabilization, proprioception, and postural balance training. Postoperative rehabilitation after spinal surgery can consist of "stabilization exercises" or can be done with "Active Video-Based Exercises (AVTE)". However, no study was found in the literature investigating the effects of these two methods on postural control and balance in AIS patients who underwent PSF surgery. The primary aim of the study is to investigate the effects of AVTE on postural control and balance in comparison with stabilization exercises in patients with AIS after PSF surgery. The secondary purpose of these exercise trainings is; to comparatively examine its effects on pain, trunk muscle strength, mobility, endurance, core stabilization, function, quality of life, and satisfaction. It is thought that this study may be an effective, innovative, technology-based approach that will contribute to the improvement of postoperative postural control and balance in AIS patients.
Cases that meet the inclusion criteria of the study will be divided into 3 groups by randomization. These groups are Group 1: Video-Based Exercise Group, Group 2: Stabilization Exercise Group, Group 3: Control Group.
The participants included in the study will be evaluated as described below. Primary evaluation parameters; There will be postural stability and static and dynamic balance. Secondary evaluation parameters will be pain, trunk mobility, muscle strength, endurance, core stabilization, functional level, physical activity level, quality of life, and satisfaction. All evaluations will be performed by an investigator blinded to the intervention method.
Participants in the experimental group will receive a total of 24 sessions of Video-Based Exercise or Stabilization Exercise treatment, 2 days a week, for 12 weeks, under the supervision of a physiotherapist, while participants in the control group will be placed on a waiting list.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 51
- Having been diagnosed with Adolescent Idiopathic Scoliosis by an orthopedic specialist
- Being between the ages of 10 and 18
- The Cobb angle determined on the anteroposterior radiograph must be over 45 degrees before surgery.
- Having had posterior spinal fusion surgery
- Between 8th week and 6 months postoperatively
- Ability to understand and follow instructions
- Volunteering to participate in the study
- Complications that prevent rehabilitation after surgery (such as postoperative cerebrospinal fluid leak, paraparesis, hemiparesis)
- Neuromuscular, rheumatic disease or vestibular problems that may affect balance, vision-related diseases
- Orthopedic problems that may prevent participation in the exercise program
- Serious lung complications associated with surgery
- Any other exercise or physical activity that may affect trunk muscle strength or balance
- Patients who cannot understand and follow instructions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group II- Exercise Group Stabilization and Strengthening Exercises Participants will be included in a total of 24 sessions of progressive, configured exercise program, supervised by a physiotherapist, 2 days a week for 12 weeks. The exercise program will be divided into 4 phases: 1-3, 4-6, 7-9, and 10-12 weeks. Sessions will last 40 minutes in total, including 5 minutes of warm-up, 30 minutes of stabilization, strengthening, and balance exercises, and 5 minutes of cool-down. Group I- Active Video Based Group Active Video Based Exercises Participants will play progressive, configured games with Nintendo Wii, supervised by a physiotherapist, 2 days a week for 12 weeks, for a total of 24 sessions. The game schedule will be divided into 4 phases: 1-3, 4-6, 7-9, and 10-12 weeks. Sessions will last 40 minutes in total, including 5 minutes of warm-up, 30 minutes of balance and sports games, and 5 minutes of cool-down. Group III- Control Group Waiting List-Spine protection principles training Participants in the control group will be placed on a waiting list for 12 weeks. Participants in the control group will be given a 30-minute spine protection principles training and the things to pay attention to will be explained. Participants will not receive any exercise intervention for 12 weeks and will be able to continue their routine physical activities.
- Primary Outcome Measures
Name Time Method Stability Limits Test 12 weeks, 6 months The postural stability of the participants will be evaluated with the "Stability Limits Test" on a static surface via the postural stability assessment system.
Sensory Integration Test 12 weeks, 6 months The static and dynamic balance of the participants will be evaluated with the "Sensory Integration Test" via the postural stability assessment system.
One-Legged Posture Test 12 weeks, 6 months The static and dynamic balance of the participants will be evaluated with the "One-Legged Posture Test" via the postural stability assessment system.
Postural Stability Test 12 weeks, 6 months The postural stability of the participants will be evaluated with the "Postural Stability Test" on a static surface via the postural stability assessment system.
- Secondary Outcome Measures
Name Time Method The side bending test 12 weeks, 6 months 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.Trunk Isometric Muscle Strength 12 weeks, 6 months 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.
Spine Pain 12 weeks, 6 months 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."
Pick-up Test 12 weeks, 6 months 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.Sock Test 12 weeks, 6 months 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.Pebble Test 12 weeks, 6 months 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.Adolescent Physical Activity Questionnaire (14-20 years old) 12 weeks, 6 months 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.
The forward bending test 12 weeks, 6 months 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".
Lateral Bridge Test 12 weeks, 6 months 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.
Trunk Extension Test 12 weeks, 6 months 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.
Core Stabilization 12 weeks, 6 months 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.
Pedometer 12 weeks, 6 months 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.
Trunk Flexion Test 12 weeks, 6 months 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.
Treatment Satisfaction 12 weeks, 6 months 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.
Child Physical Activity Questionnaire (8-14 years old) 12 weeks, 6 months 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.
Scoliosis-Specific Quality of Life 12 weeks, 6 months 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).
Trial Locations
- Locations (1)
Istanbul University-Cerrahpasa
š¹š·Istanbul, Turkey