Active Video Game-Based Exercise Training and Stability Training After AIS Surgery

NCT ID: NCT06498232

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2026-03-30

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.

Conditions

Adolescent Idiopathic Scoliosis; Spinal Fusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group I- Active Video Based Group

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 Type: EXPERIMENTAL

Active Video Based Exercises

Intervention Type: OTHER

Warm-up and cool-down will consist of aerobic games (Step, Hula Hoop, Rhythm Parade Dance, Run) available in Nintendo Wii. Balance games will consist of Penguin Slide, Soccer Heading, Table Tilt, Balance Bubble, Ski Slalom, Ski Jump, Tilt City, and Snowboard Slalom. Among the sports games, Bowling, Boxing, Tennis, and Baseball will be included in the program. In all games, progress will be made by increasing the difficulty levels, and in balance games, the game will be made more difficult with an additional balance board and bosu.

Group II- Exercise Group

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 Type: EXPERIMENTAL

Stabilization and Strengthening Exercises

Intervention Type: OTHER

Warm-up exercises will consist of active dynamic warm-up exercises. Stabilization and strengthening exercises; extremity movements will begin with teaching respiratory control in supine, prone, sitting, crawling, squat, and standing positions, and will be made more difficult with the addition of exercise tires and exercise balls. Balance exercises will start from static positions and move on to dynamic positions with the inclusion of different surfaces. In the cooling exercises, in addition to breathing exercises, stretching exercises will be performed for the trunk, upper and lower extremities.

Group III- Control Group

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.

Group Type: OTHER

Waiting List-Spine protection principles training

Intervention Type: OTHER

Participants will be placed on a waiting list. Following the initial evaluations, participants will be informed that they will be included in an exercise program at the end of 6 months. During this process, participants in the control group will be called by phone at the 6th, 12th, and 18th weeks to question their status and to remind them that they will start the exercise program after a while. It will be evaluated at the end of 6 months, and the end of the study, exercise training approaches in the intervention group will be applied to participants who wish to do so, with the same protocol and duration.

Interventions

Active Video Based Exercises

Warm-up and cool-down will consist of aerobic games (Step, Hula Hoop, Rhythm Parade Dance, Run) available in Nintendo Wii. Balance games will consist of Penguin Slide, Soccer Heading, Table Tilt, Balance Bubble, Ski Slalom, Ski Jump, Tilt City, and Snowboard Slalom. Among the sports games, Bowling, Boxing, Tennis, and Baseball will be included in the program. In all games, progress will be made by increasing the difficulty levels, and in balance games, the game will be made more difficult with an additional balance board and bosu.

Intervention Type: OTHER

Stabilization and Strengthening Exercises

Warm-up exercises will consist of active dynamic warm-up exercises. Stabilization and strengthening exercises; extremity movements will begin with teaching respiratory control in supine, prone, sitting, crawling, squat, and standing positions, and will be made more difficult with the addition of exercise tires and exercise balls. Balance exercises will start from static positions and move on to dynamic positions with the inclusion of different surfaces. In the cooling exercises, in addition to breathing exercises, stretching exercises will be performed for the trunk, upper and lower extremities.

Intervention Type: OTHER

Waiting List-Spine protection principles training

Participants will be placed on a waiting list. Following the initial evaluations, participants will be informed that they will be included in an exercise program at the end of 6 months. During this process, participants in the control group will be called by phone at the 6th, 12th, and 18th weeks to question their status and to remind them that they will start the exercise program after a while. It will be evaluated at the end of 6 months, and the end of the study, exercise training approaches in the intervention group will be applied to participants who wish to do so, with the same protocol and duration.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Ayse Zengin Alpozgen

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayse Zengin Alpozgen, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Turgut Akgül, Prof.

Role: STUDY_CHAIR

Istanbul University

Elçin Akyurek, Msc

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Locations

Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AkyurekE1

Identifier Type: -

Identifier Source: org_study_id