Structured 3D Exercise and the Conventional Exercise Program for Scoliosis in Children With Rheumatic Disease

June 13, 2023 updated by: Eylül Pınar KISA, Biruni University

Comparison of the Effectiveness of the Structured 3D Exercise and the Conventional Exercise Program for Scoliosis in Children With Rheumatic Disease

Usage including cases followed up with rheumatism diagnosis and treatment in Istanbul University-Cerrahpasa Medical Faculty Pediatric Rheumatology Clinic, Physiotherapy and Rehabilitation Unit. The study included 50 patients with a spinal x-ray scoliosis problem, aged 8-16 years, who were diagnosed with rheumatism at least 6 months ago, whose medical treatment was stable, Risser 0-4 and exercise indication (Cobb = 10-45ͦ). Patients with additional neurological diagnosis against rheumatism, who have received any previous treatment for a spine problem, who have a mental state and who do not have the consent of their family will not be included. The cases will be divided into 2 groups by method. In the first group (n = 25), structured 3-dimensional scoliosis exercises are taught in the clinic, and the second group (n = 25) is taught conventional physiotherapy applications (posture-core applications-bennet protocols) in the clinic, and both groups are followed by the WTE method.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The demographic and clinical characteristics of all subjects willing to participate in the study will be questioned with the "Sociodemographic Data Form". Sociodemographic data form; pain, age, gender, height, weight, type of rheumatism, how many years ago the patient was diagnosed, the presence of rheumatism and scoliosis in the family, the drugs used, exercise habits, exacerbation history, whether they used a device before, and the awareness of the family about scoliosis. The trunk rotation angles with the forward bend test and the Cobb angle with the SubrotoAngleAid application via x-ray. Respiratory functions will be evaluated with portable spirometer, body awareness will be evaluated with Walter Reed Visual Assessment Scale, and quality of life will be evaluated with Scoliosis Research Association Scale-22 (SRS-22). After the evaluations, in the first treatment session in the clinic, the cases in the first group; Body awareness, respiratory control, differences between rotational and normal breathing, posture exercises and core stabilization exercises will be taught and family training will be provided. In the next session, a home program will be created by applying 3D scoliosis exercises that are structured according to the needs of the patients. Body awareness, respiratory control, posture exercises and core stabilization exercises will be taught and family training will be given to the patients in the second group in the first treatment session. In the next session, conventional exercises for the needs of the cases will be taught and a home exercise program will be created. Both groups will be interviewed for 2-week periods using the WTE method, and the exercises will be progressed gradually as needed. At the beginning of the treatment and in the 6th month, all evaluations will be repeated and the effectiveness of the exercises will be investigated. SPSS (Statistical Package for Social Sciences) (SPSS 21.0) statistical program will be used in the statistical analysis of the data. In all statistical analyzes, p <0.05 will be considered significant.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İ̇stanbul, Turkey, 34720
        • Eylül Pınar Kısa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Cases with a diagnosis of rheumatism in whom scoliosis problems were detected by spine X-ray,
  • be between the ages of 8-16,
  • Being between 0-4 in the riser,
  • Being in exercise indication (Cobb=10-45 ˚)

Exclusion Criteria:

  • Having an additional neurological or orthopedic diagnosis other than scoliosis accompanying rheumatism and affecting treatment results
  • Having had any surgery on the spine
  • Have had previous scoliosis treatment poor mental state

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: schroth group
This arm was planned as the exercise group which includes Schroth 3-Dimensional scoliosis exercise.
Other: Schroth 3-Dimensional scoliosis exercise
Schroth 3-Dimensional scoliosis exercises
Experimental: conventional group
This arm was planned as the exercise group which includes conventional scoliosis exercise.
Other: conventional scoliosis exercise
conventional scoliosis exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cobb angle
Time Frame: 0-6 month
Measuring the scoliosis angle on x-ray is the most commonly used method. The Cobb angle is most commonly used to measure the magnitude of the curve. Measurements are made on a standing posteroanterior spine radiograph as standard. To determine the boundaries of the scoliosis, a line is drawn parallel to the upper line of the vertebra with the greatest deviation. Similarly, for the lower border, a line is drawn parallel to the lowest vertebra. Vertical lines are drawn parallel to these two lines and the angle between the two lines is measured. This angle is defined as the scoliosis angle (Cobb angle). Radiological imaging will only be applied to children who are considered to be in need by the doctor as a result of physical examination. The measurement of the Cobb angle will be made on the X-ray via the SubrotoAngleAid application.
0-6 month
Trunk rotation with Scoliometer
Time Frame: 0-6 month
The trunk rotation angle will be measured with a scoliometer. It is an easy to use, reliable, practical and specially designed inclinometer in the clinical evaluation of scoliosis. It is accepted as a clinical evaluation method used in addition to radiological methods in determining the efficacy of treatment and the prognosis of scoliosis.
0-6 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical deformity assesment using with The Walter Reed Visual Assessment Scale (WRVAS)
Time Frame: 0-6 month
The Walter Reed Visual Assessment Scale (WRVAS) developed to evaluate the physical deformity perceived by patients with idiopathic scoliosis. Walter Reed Visual Evaluation Scale evaluates deformity from 7 aspects; spine curvature, rib protrusion, lumbar protrusion, thorax deformity relative to pelvis (alignment disorder), trunk imbalance, shoulder and scapula asymmetry. For each of the 7 questions that make up the Walter Reed visual assessment scale, there is an answer section consisting of 5 different pictures indicating different degrees of deformity. Each deformity is scored with these pictures as a minimum of "1" and a maximum of "5". The scale will be filled in by the therapist.
0-6 month
FEV1
Time Frame: 0-6 month
It is a physiological test in which the volume of air an individual inhales or exhales is evaluated as a function of time. Pulmonary function test will be done with a portable spirometer (Contec SP10W). Forced expiration test; calm breathing followed by a forced inspiration followed by an expiration as fast and deep (forced) as possible. During the test, the patient will be placed in a sitting position in a way that is comfortable and the patient will be prevented from breathing in and out of the nose with the nose clip. Maneuvers that may affect the test results such as bending forward and neck flexion during forced expiration will be prevented. Expiration should continue for at least six seconds and eventually plateau. Care will be taken to ensure that there is no leakage in the system.
0-6 month
FVC
Time Frame: 0-6 month
It is a physiological test in which the volume of air an individual inhales or exhales is evaluated as a function of time. Pulmonary function test will be done with a portable spirometer (Contec SP10W). Forced expiration test; calm breathing followed by a forced inspiration followed by an expiration as fast and deep (forced) as possible. During the test, the patient will be placed in a sitting position in a way that is comfortable and the patient will be prevented from breathing in and out of the nose with the nose clip. Maneuvers that may affect the test results such as bending forward and neck flexion during forced expiration will be prevented. Expiration should continue for at least six seconds and eventually plateau. Care will be taken to ensure that there is no leakage in the system.
0-6 month
PEF
Time Frame: 0-6 month
It is a physiological test in which the volume of air an individual inhales or exhales is evaluated as a function of time. Pulmonary function test will be done with a portable spirometer (Contec SP10W). Forced expiration test; calm breathing followed by a forced inspiration followed by an expiration as fast and deep (forced) as possible. During the test, the patient will be placed in a sitting position in a way that is comfortable and the patient will be prevented from breathing in and out of the nose with the nose clip. Maneuvers that may affect the test results such as bending forward and neck flexion during forced expiration will be prevented. Expiration should continue for at least six seconds and eventually plateau. Care will be taken to ensure that there is no leakage in the system.
0-6 month
QUALITY OF LIFE ASSESSMENT
Time Frame: 0-6 month
Scoliosis Research Society Scale-22 (SRS-22)" questionnaire is an inquiry form designed for scoliosis and evaluating quality of life. It consists of 23 questions with five subgroups. These subgroups are; pain, image/appearance, function/activity, mental health, and treatment satisfaction. It is defined as 0 (worst) and 5 (best) points for each question. Patients will be asked to mark the answers that are suitable for them and the form will be filled. (because of pandemic, its not completed)
0-6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biruni University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PhD Thesis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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