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Clinical Trials/NCT06469021
NCT06469021
Enrolling By Invitation
Not Applicable

Effectiveness of Rehabilitation With Technology-Based Systems in Adolescent Idiopathic Scoliosis

hande tunc2 sites in 1 country30 target enrollmentOctober 14, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Scoliosis; Adolescence
Sponsor
hande tunc
Enrollment
30
Locations
2
Primary Endpoint
Cobb Angle
Status
Enrolling By Invitation
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 14, 2024
End Date
December 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
hande tunc
Responsible Party
Sponsor Investigator
Principal Investigator

hande tunc

Doctor of Philosophy Candidate (PhD(c))

Istanbul Medipol University Hospital

Eligibility Criteria

Inclusion Criteria

  • Being diagnosed with Adolescent Idiopathic Scoliosis,
  • Girls 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

Outcomes

Primary Outcomes

Cobb Angle

Time Frame: At the beginning of the study and sixth month of the study

In the treatment of scoliosis, the Cobb angle is considered the most important outcome for the evaluation of treatment efficacy. The Cobb angle is measured from anteroposterior graphs taken during standing. Measurements will be taken by a blinded assessor via SurgiMap web application to eliminate individual errors. Measurements will be made from radiographs taken at the beginning and sixth month of treatment because of the radiation exposure.

Posterior Trunk Symmetry Index (POTSI)

Time Frame: At the beginning of the study, third month and sixth month of the study

POTSI is a method that makes it possible to evaluate the trunk asymmetry of an individual with AIS from the posterior and objectively scores the cosmetic effect. It is based on certain calculations performed on a posterior photograph of the individual. The score calculated in POTSI analysis consists of the sum of 6 indices. In order to prevent possible calculation errors and standardize the measurements, the cases will be evaluated with a mobile application named POTSIApp.

Walter Reed Visuel Assessment Scale (WRVAS)

Time Frame: At the beginning of the study, third month and sixth month of the study

WRVAS is a scale that scores the severity of curvature by focusing on the person's perception of posture. It is divided into 7 parameters including body curvature, rib prominence, lumbar prominence, head-rib-pelvis positional relationship, head-pelvis relationship, shoulder level and scapula rotation. A high score means that the perceived deformity is high.

Secondary Outcomes

  • Single Leg Balance Test(At the beginning of the study, third month and sixth month of the study)
  • The Physical Activity Participation Motivation Scale (PAPMS)(At the beginning of the study, third month and sixth month of the study)
  • The System Usability Scale (SUS)(At the beginning of the study, third month and sixth month of the study)
  • Angle of Trunk Rotation(At the beginning of the study, third month and sixth month of the study)

Study Sites (2)

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