Clinical trial NCT06469021: Effectiveness of Rehabilitation with Technology-Based Systems in Adolescent Idiopathic Scoliosis
Official title: Effectiveness of Rehabilitation with Technology-Based Systems in Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Scoliosis; Adolescence
Keywords: Scoliosis
Virtual Reality
Technology Based Rehabilitation
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the effect of technology-based exercises on treatment success in adolescents with idiopathic scoliosis.

Within the scope of the study, thirty patients with AIS will be randomly allocated to two groups. The control group will apply a program with conventional approaches consisting of a combination of structured three-dimensional scoliosis exercises, core stabilization and balance exercises. Patients in the intervention group will perform structured three-dimensional scoliosis exercises, core stabilization and balance exercises similarly to the control group. However, patients in the intervention group will perform core stabilization and balance exercises with virtual reality games for twenty-four weeks. Patients' Cobb angle, Pediatric Berg Balance Scale (balance), Posterior Trunk Asymmetry Index (POTSI) (cosmetic), Walter Reed Visual Assessment Scale (WRVAS)(cosmetic), System Usability Scale (system usability) and Physical Activity Participation Motivation Scale (PAPMS) (motivation) parameters will be assess at the beginning of treatment, third and six month.

Detailed description: Adolescent idiopathic scoliosis (AIS) is a three-dimensional structural deformity in growing children, not associated with a cause, in which lateral deviation of the spine over 10° is accompanied by rotation. The magnitude of the Cobb angle is used to classify the severity of scoliosis. In immature AIS cases, if the Cobb angle is between 25°-40°, bracing and exercise therapy is applied. Exercise in AIS is performed to reduce clinical symptoms, improve cosmetics and prevent curve progression. Corrective exercises based on sensorimotor and kinesthetic principles include self-correction in front of a mirror, three-dimensional breathing techniques and home exercise programs.

Virtual reality applications (VRA) are three-dimensional computer simulations that give the individual the feeling of "being anywhere" and provide various information (light, sound and others) to the sensory organs. VRS is based on motor learning principles. The possibility of repetitive movements and computer feedback results in positive changes at the cortical level. In addition, the virtual environment increases the motivation of the individual and ensures active participation in the treatment.

A review of the literature reveals that there are very limited studies on technology-based applications or virtual reality in scoliosis rehabilitation. To the best of our knowledge, it has been observed that there is no long-term rehabilitation protocol applied on the basis of rehabilitative game therapy in AIS rehabilitation.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with Adolescent Idiopathic Scoliosis,
* Girls and boys aged between 10-15,
* Being the Cobb angle between 25-40 degrees,
* Being using three dimensional brace,
* Being immature (Risser 0-2 or Sanders 1-4 phase)
* Regular follow-ups (0-3-6 months)

Exclusion Criteria:

* Presence of previous spinal surgery,
* Progression resulting in the necessity of surgery,
* Participation in any exercise therapy program,
* Playing sports at a professional level,
* Cardiac and respiratory dysfunction and/or concomitant systemic disease,
* Health (mental, orthopedic) problems that prevent exercise

Primary outcomes:
measure: Cobb Angle
timeFrame: At the beginning of the study and sixth month of the study
measure: Posterior Trunk Symmetry Index (POTSI)
timeFrame: At the beginning of the study, third month and sixth month of the study
measure: Walter Reed Visuel Assessment Scale (WRVAS)
timeFrame: At the beginning of the study, third month and sixth month of the study
Secondary outcomes:
measure: Single Leg Balance Test
timeFrame: At the beginning of the study, third month and sixth month of the study
measure: The Physical Activity Participation Motivation Scale (PAPMS)
timeFrame: At the beginning of the study, third month and sixth month of the study
measure: The System Usability Scale (SUS)
timeFrame: At the beginning of the study, third month and sixth month of the study
measure: Angle of Trunk Rotation
timeFrame: At the beginning of the study, third month and sixth month of the study
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Training and Reserach Hospital
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
References: