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Clinical Trials/NCT06498232
NCT06498232
Enrolling By Invitation
Not Applicable

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 site in 1 country51 target enrollmentApril 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adolescent Idiopathic Scoliosis
Sponsor
Istanbul University - Cerrahpasa
Enrollment
51
Locations
1
Primary Endpoint
Stability Limits Test
Status
Enrolling By Invitation
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2024
End Date
March 30, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa
Responsible Party
Principal Investigator
Principal Investigator

Ayse Zengin Alpozgen

Assoc. Prof.

Istanbul University - Cerrahpasa

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

Outcomes

Primary Outcomes

Stability Limits Test

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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