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

NCT06498232 | Enrolling By Invitation

• 1 other identifier: AkyurekE1
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis; Spinal Fusion

Keywords

scoliosis; postural control; active video-based exercises; stabilization training; scoliosis surgery; post-op rehabilitation; balance

Outcome Measures

Primary Outcomes (4)

• Postural Stability Test

  The postural stability of the participants will be evaluated with the "Postural Stability Test" on a static surface via the postural stability assessment system.

  12 weeks, 6 months

• Stability Limits Test

  The postural stability of the participants will be evaluated with the "Stability Limits Test" on a static surface via the postural stability assessment system.

  12 weeks, 6 months

• Sensory Integration Test

  The static and dynamic balance of the participants will be evaluated with the "Sensory Integration Test" via the postural stability assessment system.

  12 weeks, 6 months

• One-Legged Posture Test

  The static and dynamic balance of the participants will be evaluated with the "One-Legged Posture Test" via the postural stability assessment system.

  12 weeks, 6 months

Secondary Outcomes (16)

• Spine Pain

  12 weeks, 6 months

• The forward bending test

  12 weeks, 6 months

• The side bending test

  12 weeks, 6 months

• Trunk Isometric Muscle Strength

  12 weeks, 6 months

• Lateral Bridge Test

  12 weeks, 6 months

Study Arms (3)

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.

Other: Active Video Based Exercises

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.

Other: Stabilization and Strengthening Exercises

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.

Other: Waiting List-Spine protection principles training

Interventions

Active Video Based Exercises OTHER

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 an additional balance board and bosu.

Group I- Active Video Based Group

Stabilization and Strengthening Exercises OTHER

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 breathing exercises, stretching exercises will be performed for the trunk, upper and lower extremities.

Group II- Exercise Group

Waiting List-Spine protection principles training OTHER

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 in the intervention group will be applied to participants who wish to do so, with the same protocol and duration.

Group III- Control Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Ayse Zengin Alpozgen, Assoc. Prof.

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Turgut Akgül, Prof.

  Istanbul University

  STUDY CHAIR

• Elçin Akyurek, Msc

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 12, 2024
• Study Start: April 15, 2024
• Primary Completion: September 30, 2025
• Study Completion: March 30, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-07

Locations

TU (1)