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

NCT06469021 | Enrolling By Invitation DMC

• 1 other identifier: E-10840098-202.3.02-3224
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Scoliosis; Adolescence

Keywords

Scoliosis; Virtual Reality; Technology Based Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Cobb Angle

  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.

  At the beginning of the study and sixth month of the study

• Posterior Trunk Symmetry Index (POTSI)

  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.

  At the beginning of the study, third month and sixth month of the study

• Walter Reed Visuel Assessment Scale (WRVAS)

  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.

  At the beginning of the study, third month and sixth month of the study

Secondary Outcomes (4)

• 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 Arms (2)

Control Group:

ACTIVE COMPARATOR

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).

Other: Conservative Approach

Rehabilitative Game Based Exercise Group

EXPERIMENTAL

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).

Other: Rehabilitative Game Therapy

Interventions

Conservative Approach 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).

Control Group:

Rehabilitative Game Therapy 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.

Rehabilitative Game Based Exercise Group

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• hande tunc: lead

Study Sites (2)

Gaziosmanpasa Training and Reserach Hospital

Istanbul, Turkey (Türkiye)

Location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of Philosophy Candidate (PhD(c))

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: June 21, 2024
• Study Start: October 14, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 16, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)