Ignite Creation Date:
2024-07-17 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498232
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-12
First Post:
2024-06-27
Brief Title:
Active Video Game-Based Exercise Training and Stability Training After AIS Surgery
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
Effects of Structured Active Video Game-Based Exercise Training and Stabilization Training on Postural Control and Balance After Scoliosis Surgery in Adolescents
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None