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

NCT ID: NCT05861856

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-29

Study Completion Date

2023-11-12

Brief Summary

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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.

Detailed Description

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Male and female volunteer patients who were diagnosed with "Adolescent Idiopathic Scoliosis" and referred to physical therapy and met the inclusion criteria will be included in the study. Patients whose families and themselves agreed to participate voluntarily in this study will be randomly divided into three groups and included in the study. Virtual reality supported core stabilization exercises (stability enhancing exercises for the muscles around the spine), manual therapy (mobilization for the spine, mobilization and relaxation methods for the soft tissues around the spine) techniques for the second group, and both virtual reality supported core stabilization exercises and exercises for the third group were given to the third group. Manual therapy techniques will also be applied. The treatment program was planned as a total of 16 sessions, 2 days a week for 8 weeks. This study was planned as single-blind for the purpose of impartiality of the evaluation.

Conditions

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Adolescent Idiopathic Scoliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Virtual reality group

Virtual reality supported core stabilization exercises will be performed.

Group Type ACTIVE_COMPARATOR

Virtual reality

Intervention Type OTHER

Virtual reality supported core stabilization exercises will be performed.

Manual therapy group

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

Group Type ACTIVE_COMPARATOR

Manual therapy

Intervention Type OTHER

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

Combine group

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

Group Type ACTIVE_COMPARATOR

Manual therapy

Intervention Type OTHER

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

Virtual reality

Intervention Type OTHER

Virtual reality supported core stabilization exercises will be performed.

Interventions

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Manual therapy

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

Intervention Type OTHER

Virtual reality

Virtual reality supported core stabilization exercises will be performed.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Eylem KÜÇÜK

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eylem Küçük

Role: PRINCIPAL_INVESTIGATOR

Amasya University

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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HacettepeUEK

Identifier Type: -

Identifier Source: org_study_id