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临床试验/NCT06498232
NCT06498232Enrolling By Invitation不适用

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

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2024年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
51
试验地点
1
主要终点
Stability Limits Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Group I- Active Video Based Group

Experimental

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.

干预措施: Active Video Based Exercises (Other)

Group II- Exercise Group

Experimental

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.

干预措施: Stabilization and Strengthening Exercises (Other)

Group III- Control Group

Other

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.

干预措施: Waiting List-Spine protection principles training (Other)

结局指标

主要结局

Stability Limits Test

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • The side bending test(12 weeks, 6 months)
  • Trunk Isometric Muscle Strength(12 weeks, 6 months)
  • Spine Pain(12 weeks, 6 months)
  • Pick-up Test(12 weeks, 6 months)
  • Sock Test(12 weeks, 6 months)
  • Pebble Test(12 weeks, 6 months)
  • Adolescent Physical Activity Questionnaire (14-20 years old)(12 weeks, 6 months)
  • The forward bending test(12 weeks, 6 months)
  • Lateral Bridge Test(12 weeks, 6 months)
  • Trunk Extension Test(12 weeks, 6 months)
  • Core Stabilization(12 weeks, 6 months)
  • Pedometer(12 weeks, 6 months)
  • Trunk Flexion Test(12 weeks, 6 months)
  • Treatment Satisfaction(12 weeks, 6 months)
  • Child Physical Activity Questionnaire (8-14 years old)(12 weeks, 6 months)
  • Scoliosis-Specific Quality of Life(12 weeks, 6 months)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse Zengin Alpozgen

Assoc. Prof.

Istanbul University - Cerrahpasa

研究点 (1)

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