Effectiveness of Virtual Reality- Based Rehabilitation Program in Individuals With Adolescent Idiopathic Scoliosis After Posterior Fusion Surgery

Not Applicable

• Conditions: Adolescent Idiopathic Scoliosis (AIS)

• Registration Number: NCT06753383
• Lead Sponsor: Elif Yagmur Ozger

Brief Summary

The aim of this clinical study is to investigate the effect of virtual reality based rehabilitation program on kinesiophobia, respiratory muscle strength, spinal mobility, physical activity, spinopelvic parameters and quality of life after posterior fusion surgery in individuals diagnosed with Adolescent Idiopathic Scoliosis (AIS). The main questions it aims to answer are:

* Does a virtual reality based rehabilitation program after posterior fusion surgery have an effect on kinesiophobia, respiratory muscle strength, spinal mobility, physical activity, spinopelvic parameters and quality of life in individuals diagnosed with AIS?

* Is the virtual reality-based rehabilitation program after posterior fusion surgery more effective for individuals diagnosed with AIS than the routine physiotherapy and rehabilitation program applied in the clinic?

They will compare it with the \[routine physiotherapy and rehabilitation program\] to see if the virtual reality-based rehabilitation program is effective in individuals with AIS after posterior fusion.

Participants :

After being evaluated in terms of kinesiophobia, respiratory muscle strength, spinal mobility, physical activity, spinopelvic parameters and quality of life, the Virtual Reality-Based Exercise Group will be given an exercise program via the games in Kinect Sports Ultimate for 30 minutes a day for a total of 6 weeks, 2 days . At the end of the 6 week, the participants will be re-evaluated and the results will be compared according to the control group.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-10
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-22
• Study First Posted: 2024-12-31
• Primary Completion: 2025-04-25
• Status Verified: 2025-07
• Study Completion: 2025-07-21
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-24

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Diagnosed with AIS December 10-18
• Underwent posterior spinal fusion surgery
• Post-operative (post-op) 6.during the week and after
• Absence of vision, speech and hearing problems
• Regular participation in the program to be implemented
• Volunteering of individuals

Exclusion Criteria

• Have a history of previous spinal surgery
• Have any contraindications to exercise
• Have a mental problem
• Have a neuromuscular, mesenchymal, rheumatic disease
• Have pulmonary and cardiac complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Spinal Mobility	6 weeks	The spinal mobility of the participants will be measured with the modified Schober test before and after 6 weeks of treatment. When the person is in an upright position, the lumbosacral junction and 10 cm above will be marked, and a third marker will be placed 5 cm below the lumbosacral junction. After the anterior flexion, which is performed as far forward as possible, the distance between the top and bottom deceleration will be measured and the test will be terminated.
Respiratory Muscle Strength	6 weeks	The respiratory muscle strength of the participants will be measured according to the criteria of the American Thoracic Society /European Respiratory Society using a portable, electronic intraoral pressure measuring device. After the maximum expiration, the participant will be asked to perform maximal inspiration lasting at least 1.5 seconds in the residual volume. At the total lung capacity after maximum inspiration, the person will be asked to perform a maximum expiration lasting at least 1.5 seconds against the closed system. The tests will be applied in a sitting position with the nose closed with a soft latch. Of at least three measurements that are technically acceptable and do not differ by more than 5 cmH₂O from each other, the highest one will be recorded.

Secondary Outcome Measures

Name	Time	Method
Spinopelvic Parameters	6 weeks	All the spinal anterior, posterior and lateral spine ortho x-rays of the participants and spinal parameters and pelvic parameters will be measured before and after virtual reality based rehabilitation applications and the effect of virtual reality based rehabilitation program on the sagittal balance of the spine will be examined
Physical Activity	6 weeks	Individuals with AIS will be taught to use pedometers and will be asked to use the device from the moment they get up in the morning until the moment they go to bed at night for 6 weeks, to record the number of steps values before going to bed at night.
Kinesiophobia	6 weeks	Participants' fear of movement will be questioned using the TAMPA Kinesiophobia scale. The minimum score that can be taken from the scale is 17 and the maximum score is 68. High scores indicate that the patient's fear of movement is high.
Scoliosis Quality of Life	6 weeks	The Scoliosis Research Society-22 Questionnaire (SRS-22) will be used to evaluate the health-related quality of life of individuals with AIS before and after rehabilitation practices performed via virtual reality. The score range for each item ranges from zero (worst) to five (best). Decembers are applied to the following items. The sum of the points received from all the questions will be divided by the total number of questions and the total score will be obtained. A high score indicates that the quality of life is increasing, a low score indicates that it is decreasing.

Trial Locations

Locations (1)

Istanbul University Faculty of Medicine Department of Orthopedics and Traumatology; 🇹🇷 Istanbul, Fatih, Turkey