NCT06753383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 31, 2024

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2025

Completed
Last Updated

March 31, 2026

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

December 16, 2024

Last Update Submit

March 27, 2026

Conditions

Keywords

Adolescent Idiopathic Scoliosisvirtual reality based rehabilitationRespiratory Muscle StrengthPosterior Fusion Surgeryspinal mobilitykinesiophobiaspinopelvic parameter

Outcome Measures

Primary Outcomes (2)

  • Spinal Mobility

    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.

    6 weeks

  • Respiratory Muscle Strength

    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.

    6 weeks

Secondary Outcomes (4)

  • Spinopelvic Parameters

    6 weeks

  • Physical Activity

    6 weeks

  • Kinesiophobia

    6 weeks

  • Scoliosis Quality of Life

    6 weeks

Study Arms (2)

Virtual Reality Based Exercise Group

EXPERIMENTAL

The Virtual Reality Based Exercise Group will be given an exercise program based on the games in Kinect Sports Ultimate (Soccer, Basketball, Skiing, Tennis, Baseball, Volleyball, Boxing, Track \& Field) for 30 minutes a day for a total of 6 weeks, 2 days a week. The games include movements such as lateral flexion, extension and flexion of the torso and upper limb movements, running, short-urea standing on one leg, jumping.

Other: To the Virtual Reality Based Exercise

Control Group

ACTIVE COMPARATOR

The participants who make up the control group will be followed up with a routine physiotherapy and rehabilitation program for 6 weeks.

Other: Routine physiotherapy and rehabilitation program

Interventions

After posterior fusion surgery, a rehabilitation program will be applied to individuals with AIS using Kinect Sports Ultimate for 30 minutes per day for a total of 6 weeks, 2 days a week.

Virtual Reality Based Exercise Group

14 patients with posterior fusion AIS routinely in the postoperative clinic for 6 weeks. the physiotherapy program used will be applied.

Control Group

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Faculty of Medicine Department of Orthopedics and Traumatology

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (3)

  • Hawes MC. The use of exercises in the treatment of scoliosis: an evidence-based critical review of the literature. Pediatr Rehabil. 2003 Jul-Dec;6(3-4):171-82. doi: 10.1080/0963828032000159202.

    PMID: 14713583BACKGROUND
  • Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.

    PMID: 29435499BACKGROUND
  • Dahl-Popolizio S, Loman J, Cordes CC. Comparing Outcomes of Kinect Videogame-Based Occupational/Physical Therapy Versus Usual Care. Games Health J. 2014 Jun;3(3):157-61. doi: 10.1089/g4h.2014.0002. Epub 2014 Apr 17.

    PMID: 26196174BACKGROUND

MeSH Terms

Conditions

Kinesiophobia

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Berk NIMETOGLU, Medical Doctor

    Istanbul University Faculty of Medicine Department of Orthopedics and Traumatology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

December 16, 2024

First Posted

December 31, 2024

Study Start

July 10, 2024

Primary Completion

January 7, 2025

Study Completion

February 20, 2025

Last Updated

March 31, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

it has been stated that it is necessary to protect the patient information contained in the patient rights regulation, and since the data must be stored, no sharing will be made. If necessary, the data will be shared collectively. Data will not be shared individually.

Locations