Manual Therapy and Virtual Reality Supported in Patient With Adolescent Idiopathic Scoliosis

NCT05861856 | Completed DMC

• 1 other identifier: HacettepeUEK
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescent Idiopathic Scoliosis is a three-dimensional deformity of the trunk and spine of unknown cause seen in adolescents. There are various conservative treatment methods to treat scoliosis. Manual therapy and exercises are a few of these treatments. There are studies showing that manual therapy reduces the severity of curvature, increases range of motion, modulates tissue/muscle extensibility, improves soft tissue movement limitation, relieves pain, and increases psychological well-being in scoliosis patients. In order to treat scoliosis, there are various exercise applications that are applied specifically to scoliosis, from physiotherapy applications. Core stabilization is one of the exercise methods that aim to keep the spine in the center. Virtual reality, on the other hand, is a three-dimensional simulation model that gives its participants the feeling of reality and allows mutual communication with a dynamic environment created by computers. Virtual reality is a method that provides the opportunity to work with task-based techniques by creating stimulating and entertaining environments, using people's interests and motivations. In a study, it was stated that two of the scoliosis-specific exercises were done through video-assisted games, but they stated that there was no difference because the number of exercises was low. Therefore, in this study, it was aimed to apply core stabilization exercises to scoliosis patients with virtual reality application and to investigate their effects on recovery in patients. In addition, it is planned to investigate whether the severity of the curvature in patients decreases further and whether it has an effect on other healing parameters by using the virtual reality treatment application together with manual treatment.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Adolescent idiopathic scoliosis; Manual therapy; Virtual reality; Core stabilization exercises

Outcome Measures

Primary Outcomes (2)

• Cobb angle

  The most accepted way of scoliosis evaluation is Cobb angle measurement performed on frontal plane x-ray. The Cobb angle is the curvature of the spine, and measuring it is essential for determining the severity of scoliosis, selecting the best course of action, and monitoring the progression or regression of cases following treatment. The Cobb angle measure as the vertically intersecting angle after determining the vertebrae above the apex and below the apex, which are the most tilted from the concave side of the curvature of the spine.

  Change from pretreatment and 8 weeks after treatment.

• Angle of Trunk Rotation

  It assessed with a Bunnell scoliometer is a type of inclinometer that measures the asymmetry of the degree of axial rotation on both sides of the body. Assessment is in a standing, forward-bending position bent-over position (arms dangling, palms pressed together) with the pelvis horizontal, and subject standing on a foot template

  Change from pretreatment and 8 weeks after treatment.

Secondary Outcomes (2)

• Walter Reed Visual Assessment Scale

  Change from pretreatment and 8 weeks after treatment.

• Scoliosis Research Society-22

  Change from pretreatment and 8 weeks after treatment.

Study Arms (3)

Virtual reality group

ACTIVE COMPARATOR

Virtual reality supported core stabilization exercises will be performed.

Other: Virtual reality

Manual therapy group

ACTIVE COMPARATOR

Mobilization for the spine, mobilization and relaxation methods for the soft tissues around the spine will be performed.

Other: Manual therapy

Combine group

ACTIVE COMPARATOR

Both virtual reality supported core stabilization exercises and manual therapy techniques will be applied.

Other: Manual therapy; Other: Virtual reality

Interventions

Manual therapy OTHER

Mobilization for the spine, mobilization and relaxation methods for the soft tissues around the spine will be performed.

Combine group; Manual therapy group

Virtual reality OTHER

Virtual reality supported core stabilization exercises will be performed.

Combine group; Virtual reality group

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients diagnosed with AIS
• Age 10-16 years
• Cobb angle was between 10° and 25
• Risser sing did not exceed 4
• Informed consent forms were signed by the parents and children

You may not qualify if:

• Used brace,
• Had previous spinal surgery, inferior limb length difference,
• Could not exercise due to another injury/diagnosis,
• Had neuromuscular, psychiatric, cardiovascular, respiratory insufficiency and mental disability

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Eylem Küçük

  Amasya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: May 17, 2023
• Study Start: July 29, 2023
• Primary Completion: October 4, 2023
• Study Completion: November 12, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2 years
• Access Criteria: upon request

Locations

TU (1)