Clinical trial NCT06498232: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Spinal Fusion
Keywords: scoliosis
postural control
active video-based exercises
stabilization training
scoliosis surgery
post-op rehabilitation
balance
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 51
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Postural Stability Test
timeFrame: 12 weeks, 6 months
measure: Stability Limits Test
timeFrame: 12 weeks, 6 months
measure: Sensory Integration Test
timeFrame: 12 weeks, 6 months
measure: One-Legged Posture Test
timeFrame: 12 weeks, 6 months
Secondary outcomes:
measure: Spine Pain
timeFrame: 12 weeks, 6 months
measure: The forward bending test
timeFrame: 12 weeks, 6 months
measure: The side bending test
timeFrame: 12 weeks, 6 months
measure: Trunk Isometric Muscle Strength
timeFrame: 12 weeks, 6 months
measure: Lateral Bridge Test
timeFrame: 12 weeks, 6 months
measure: Trunk Extension Test
timeFrame: 12 weeks, 6 months
measure: Trunk Flexion Test
timeFrame: 12 weeks, 6 months
measure: Core Stabilization
timeFrame: 12 weeks, 6 months
measure: Sock Test
timeFrame: 12 weeks, 6 months
measure: Pick-up Test
timeFrame: 12 weeks, 6 months
measure: Pebble Test
timeFrame: 12 weeks, 6 months
measure: Child Physical Activity Questionnaire (8-14 years old)
timeFrame: 12 weeks, 6 months
measure: Adolescent Physical Activity Questionnaire (14-20 years old)
timeFrame: 12 weeks, 6 months
measure: Pedometer
timeFrame: 12 weeks, 6 months
measure: Scoliosis-Specific Quality of Life
timeFrame: 12 weeks, 6 months
measure: Treatment Satisfaction
timeFrame: 12 weeks, 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ayse Zengin Alpozgen, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Turgut Akgül, Prof.
role: STUDY_CHAIR
affiliation: Istanbul University - Cerrahpasa
name: Elçin Akyurek, Msc
role: PRINCIPAL_INVESTIGATOR
References: