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

Official title

Effects of Structured Active Video Game-Based Exercise Training and Stabilization Training on Postural Control and Balance After Scoliosis Surgery in Adolescents

Overview

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.

Interventions

• Other 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 a
• 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 b
• 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 i

Primary outcome measures

• Postural Stability Test [Time frame: 12 weeks, 6 months]
• Stability Limits Test [Time frame: 12 weeks, 6 months]
• Sensory Integration Test [Time frame: 12 weeks, 6 months]
• One-Legged Posture Test [Time frame: 12 weeks, 6 months]

Secondary outcome measures (12)

• Spine Pain [Time frame: 12 weeks, 6 months]
• The forward bending test [Time frame: 12 weeks, 6 months]
• The side bending test [Time frame: 12 weeks, 6 months]
• Trunk Isometric Muscle Strength [Time frame: 12 weeks, 6 months]
• Lateral Bridge Test [Time frame: 12 weeks, 6 months]
• Trunk Extension Test [Time frame: 12 weeks, 6 months]
• Trunk Flexion Test [Time frame: 12 weeks, 6 months]
• Core Stabilization [Time frame: 12 weeks, 6 months]
• Sock Test [Time frame: 12 weeks, 6 months]
• Pick-up Test [Time frame: 12 weeks, 6 months]
• Pebble Test [Time frame: 12 weeks, 6 months]
• Child Physical Activity Questionnaire (8-14 years old) [Time frame: 12 weeks, 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Istanbul University-Cerrahpasa — Istanbul

Identifiers

NCT: NCT06498232 · AkyurekE1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗