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

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual therapy
Virtual reality
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring Adolescent idiopathic scoliosis, Manual therapy, Virtual reality, Core stabilization exercises

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Virtual reality group

Manual therapy group

Combine group

Arm Description

Virtual reality supported core stabilization exercises will be performed.

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

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Walter Reed Visual Assessment Scale
It was designed to measure physical deformity as perceived by patients with idiopathic scoliosis. The scale assesses seven aspects of the deformity: spinal curvature, rib prominence, flank prominence, deformity/alignment of the thorax with respect to the pelvis, trunk imbalance, shoulder asymmetry and scapular asymmetry. Scores for each catagory range from 1 (no deformity) to 5 (the worst deformity), and the total score is generated from the sum of the scores from the seven domains.
Scoliosis Research Society-22
Scale is a simple and practical quality of life questionnaire specially created for individuals with scoliosis. SRS includes parameters such as pain, self-image/appearance, function/activity, mental health, and satisfaction with treatment. It is also stated that it is effective in evaluating the changes that occur with treatment. The questionnaire has a total of 22 items that are scored from 1 (worst) to 5 (best) for each item.

Full Information

First Posted
May 7, 2023
Last Updated
September 21, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05861856
Brief Title
Manual Therapy and Virtual Reality Supported in Patient With Adolescent Idiopathic Scoliosis
Official Title
Comparison of the Efficiency of Manual Therapy and Virtual Reality Supported Core Stabilization Exercises in Patient With Adolescent Idiopathic Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 29, 2023 (Actual)
Primary Completion Date
October 4, 2023 (Anticipated)
Study Completion Date
November 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
Adolescent idiopathic scoliosis, Manual therapy, Virtual reality, Core stabilization exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality group
Arm Type
Active Comparator
Arm Description
Virtual reality supported core stabilization exercises will be performed.
Arm Title
Manual therapy group
Arm Type
Active Comparator
Arm Description
Mobilization for the spine, mobilization and relaxation methods for the soft tissues around the spine will be performed.
Arm Title
Combine group
Arm Type
Active Comparator
Arm Description
Both virtual reality supported core stabilization exercises and manual therapy techniques will be applied.
Intervention Type
Other
Intervention Name(s)
Manual therapy
Intervention Description
Mobilization for the spine, mobilization and relaxation methods for the soft tissues around the spine will be performed.
Intervention Type
Other
Intervention Name(s)
Virtual reality
Intervention Description
Virtual reality supported core stabilization exercises will be performed.
Primary Outcome Measure Information:
Title
Cobb angle
Description
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.
Time Frame
Change from pretreatment and 8 weeks after treatment.
Title
Angle of Trunk Rotation
Description
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
Time Frame
Change from pretreatment and 8 weeks after treatment.
Secondary Outcome Measure Information:
Title
Walter Reed Visual Assessment Scale
Description
It was designed to measure physical deformity as perceived by patients with idiopathic scoliosis. The scale assesses seven aspects of the deformity: spinal curvature, rib prominence, flank prominence, deformity/alignment of the thorax with respect to the pelvis, trunk imbalance, shoulder asymmetry and scapular asymmetry. Scores for each catagory range from 1 (no deformity) to 5 (the worst deformity), and the total score is generated from the sum of the scores from the seven domains.
Time Frame
Change from pretreatment and 8 weeks after treatment.
Title
Scoliosis Research Society-22
Description
Scale is a simple and practical quality of life questionnaire specially created for individuals with scoliosis. SRS includes parameters such as pain, self-image/appearance, function/activity, mental health, and satisfaction with treatment. It is also stated that it is effective in evaluating the changes that occur with treatment. The questionnaire has a total of 22 items that are scored from 1 (worst) to 5 (best) for each item.
Time Frame
Change from pretreatment and 8 weeks after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eylem Kucuk, PhDc
Phone
+905067025859
Email
eylemkucuk@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ertuğrul Deniz Köse, PhDc
Phone
+905056740998
Email
ertugruldenizkose@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eylem Küçük
Organizational Affiliation
Amasya University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eylem Küçük, PhDc
Phone
+905067025859
Email
eylemkucuk@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD, all IPD that underlie results in a publication
IPD Sharing Time Frame
2 years
IPD Sharing Access Criteria
upon request

Learn more about this trial

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

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