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

H

hande tunc

Status

Invitation-only

Conditions

Scoliosis; Adolescence

Treatments

Other: Conservative Approach
Other: Rehabilitative Game Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06469021
E-10840098-202.3.02-3224

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

Female

Ages

10 to 15 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Control Group:
Active Comparator group
Description:
The control group will perform the structured three-dimensional scoliosis exercise, core stabilization, and balance exercise with conventional methods at the clinic and home setting for twenty-four weeks. In the clinical setting, patients will perform their exercise for 2 days a week for 12 weeks, 1 day a week for the next 12 weeks, under the supervision of a physiotherapist. Patients will be asked to perform their exercises as a home exercise program on the remaining days (home exercise program 3 days a week for the first 12 weeks, 4 days a week after week 12).
Treatment:
Other: Conservative Approach
Rehabilitative Game Based Exercise Group
Experimental group
Description:
The Rehabilitative Game-Based Exercise group will perform the structured three-dimensional scoliosis exercise with conventional methods similar to the control group. Differently, technology-based systems (BeCure Systems) will be used in the implementation of core stabilization and balance exercises. Patients will be asked to perform their exercises as a home exercise program on the remaining days (home exercise program 3 days a week for the first 12 weeks, 4 days a week after week 12).
Treatment:
Other: Rehabilitative Game Therapy

Trial contacts and locations

2

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Central trial contact

Hande TUNÇ, Phd(c); Devrim TARAKCI, Assoc.Prof.Dr.

Data sourced from clinicaltrials.gov

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