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

NCT ID: NCT06469021

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-14
• Study Completion Date: 2027-12-31

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.

Conditions

Scoliosis; Adolescence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group:

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).

Group Type: ACTIVE_COMPARATOR

Conservative Approach

Intervention Type: OTHER

Structured scoliosis exercises will be prescribed by the physiotherapist according to the severity of the curvature and cosmetics of the individuals. In a one session period, 5-minute warm-up and cool-down periods, 20 minutes of scoliosis exercises, 10 minutes of core stabilization exercises and 10 minutes of balance training will be applied. The exercises will start from an easy level and the level of difficulty will be gradually increased. The assessments will be evaluated in three stages: at the beginning of treatment, at the third month of treatment and at the end of treatment (sixth month).

Rehabilitative Game Based Exercise Group

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).

Group Type: EXPERIMENTAL

Rehabilitative Game Therapy

Intervention Type: OTHER

Structured scoliosis exercises will be prescribed by the physiotherapist according to the severity of the curvature and cosmetics of the patients and will be applied to the patients with a conventional approach. In a one-session period, 5-minute warm-up and cool-down periods, 20 minutes of scoliosis exercises, 10 minutes of core stabilization exercises, and 10 minutes of balance training will be applied in the clinical setting. Home exercises will be performing with the SmartPose system differently from the control group. The SmartPose system is a special software system that enables the user to perform movements with a tablet or phone without the need for any sensors.

Interventions

Conservative Approach

Structured scoliosis exercises will be prescribed by the physiotherapist according to the severity of the curvature and cosmetics of the individuals. In a one session period, 5-minute warm-up and cool-down periods, 20 minutes of scoliosis exercises, 10 minutes of core stabilization exercises and 10 minutes of balance training will be applied. The exercises will start from an easy level and the level of difficulty will be gradually increased. The assessments will be evaluated in three stages: at the beginning of treatment, at the third month of treatment and at the end of treatment (sixth month).

Intervention Type: OTHER

Rehabilitative Game Therapy

Structured scoliosis exercises will be prescribed by the physiotherapist according to the severity of the curvature and cosmetics of the patients and will be applied to the patients with a conventional approach. In a one-session period, 5-minute warm-up and cool-down periods, 20 minutes of scoliosis exercises, 10 minutes of core stabilization exercises, and 10 minutes of balance training will be applied in the clinical setting. Home exercises will be performing with the SmartPose system differently from the control group. The SmartPose system is a special software system that enables the user to perform movements with a tablet or phone without the need for any sensors.

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

hande tunc

OTHER

Sponsor Role: lead

Responsible Party

hande tunc

Doctor of Philosophy Candidate (PhD(c))

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Gaziosmanpasa Training and Reserach Hospital

Istanbul, , Turkey (Türkiye)

Istanbul Medipol University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-10840098-202.3.02-3224

Identifier Type: -

Identifier Source: org_study_id