Investigation of the Effects of Exercise and Kinesiological Taping on Spinal Deformities and Serum Markers in Individuals With Scoliosis

March 25, 2024 updated by: Birgül Dıngırdan, Hacettepe University

Investigation of the Effects of Exercise and Kinesiological Taping on Spinal Deformities

The aim of this study is to investigate the effects of Schroth exercises and kinesiological taping on spinal deformities and serum markers in young adults with scoliosis. The study will include young adults aged 18-21 with scoliosis. A total of 57 participants will be included in the study. Out of 57 participants, 38 have scoliosis, and 19 are healthy. 38 participants will be randomly divided into 2 groups. One group (n=19) will receive only Schroth exercises, and the other group (n=19) will receive both Schroth exercises and kinesiological taping. The laboratory analyses of proteins associated with autophagy (Beclin-1, LC3, and ATG3) and bone-cartilage metabolism (COMP and MMP-3) will be conducted in the Biomedical Engineering Laboratory of our university. Trunk rotation will be assessed using the Adams Forward Bend Test with scoliometer, quality of life will be evaluated with the SRS-22 Quality of Life questionnaire and Quality of life profile for spinal deformities questionnaire, perception of deformity will be measured using the Walter Reed Visual Assessment Scale, and Cobb angles will be evaluated from anterior-posterior X-ray images.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to investigate the effects of Schroth exercises and kinesiological taping on spinal deformities and serum markers in young adults with scoliosis. The study will include young adults aged 18-21 with scoliosis. A total of 57 participants will be included in the study. Out of 57 participants, 38 have scoliosis, and 19 are healthy. 38 participants will be randomly divided into 2 groups. One group (n=19) will receive only Schroth exercises, and the other group (n=19) will receive both Schroth exercises and kinesiological taping. The laboratory analyses of proteins associated with autophagy (Beclin-1, LC3, and ATG3) and bone-cartilage metabolism (COMP and MMP-3) will be conducted in the Biomedical Engineering Laboratory of our university. Schroth exercises will be administered to both groups twice a week for 12 weeks. Kinesiological taping will be applied twice a week to the group receiving both Schroth exercises and kinesiological taping. Pre-treatment evaluations will include assessments of Cobb angles, trunk rotation, serum markers, quality of life and perception of deformity. Post treatment evaluations will include assessments of trunk rotation, cobb angles, serum markers, quality of life and perception of deformity.

Study Type

Interventional

Enrollment (Estimated)

57

Phase

  • 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 Contact

Study Contact Backup

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The individuals who agree to the study conditions and will continue with the treatment protocol.
  • 18-21 years
  • Individuals with scoliosis

Exclusion Criteria:

  • Individuals with metabolic problems such as diabetes, thyroid issues, kidney problems, etc.
  • Individuals with joint diseases such as septic arthritis, viral arthritis, rheumatoid arthritis, etc.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise group
For 12 weeks, participants will receive rotational breathing, correction techniques, positioning, mobilization, and three-dimensional exercises specific to their curvature twice a week.
Other: Just Exercise
Schroth exercises are including rotational breathing, correction techniques, positioning, mobilization, and three-dimensional exercises specific to their curvature.
Experimental: Exercise and taping group
For 12 weeks, participants will schroth exercises including receive rotational breathing, correction techniques, positioning, mobilization and three dimensional exercises specific to their curvature and kinesiological taping. Kinesiological taping will be applied as a tone enhancer or tone reducer according to the concave and convex sides of the curve.
Other: Exercise
Schroth exercises are including rotational breathing, correction techniques, positioning, mobilization, and three-dimensional exercises specific to their curvature.
Other: Taping
Kinesiological taping will be applied as a tone enhancer or tone reducer according to the the concave and convex sides of the curve.
No Intervention: Healthy people
Healthy individuals without scoliosis will be included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trunk rotation
Time Frame: At the beginning of the study and three months later
This method assesses spinal rotation caused by scoliosis. Individuals were asked to stand with their feet together and shoulders width apart, and then to bend forward. Rotation degrees were measured using a scoliometer.
At the beginning of the study and three months later
Cobb angles
Time Frame: At the beginning of the study and three months later
At the beginning and end of the study, participants will have their Cobb angle evaluated from anterior-posterior and posterior-anterior X-ray images.
At the beginning of the study and three months later
Serum markers
Time Frame: At the beginning of the study and three months later
The laboratory analyses of proteins associated with autophagy (Beclin-1, LC3, and ATG3) and bone-cartilage metabolism (COMP and MMP-3) will be conducted in the Biomedical Engineering Laboratory of our university.
At the beginning of the study and three months later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life with scoliosis people
Time Frame: At the beginning of the study and three months later
The Scoliosis Research Society developed the SRS-22 scale, which is widely accepted for assessing the health-related quality of life in scoliosis patients. Quality of life will be assessed using the SRS-22 questionnaire. The SRS-22 scale consists of 22 questions and 5 subgroups. The subgroups include pain, general appearance (image), spinal function, mental health, and satisfaction with treatment. Scores obtained from each subgroup range from 5 to 25 for pain, general appearance (image), and spinal function, and from 2 to 10 for satisfaction with treatment. Scores are calculated by assigning a response value to each of the 22 questions within a 5-point rating scale. Each statement contains responses ranging from negative to positive. The most negative response receives 1 point, while the most positive receives 5 points. Higher scores on the scale indicate an increase in quality of life, while lower scores indicate a decrease.
At the beginning of the study and three months later
Body image assessment
Time Frame: At the beginning of the study and three months later
Body image assessment will be assessed using the Walter Reed Visual Assessment Scale. WRVAS is a scale developed to evaluate the physical deformity in individuals with scoliosis and the effectiveness of treatment in improving body deformities. It consists of visual representations representing spinal curvature, rib prominence, prominence of the waist, positional relationship of the head-thoracic cage-pelvis, relationship of the head to the pelvis, shoulder level, and scapular rotation. Each deformity in the visuals is scored from a minimum of "1" to a maximum of "5," with higher scores indicating a higher perceived deformity.
At the beginning of the study and three months later

Collaborators and Investigators

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

Sponsor

Hacettepe 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 (Estimated)

April 4, 2024

Primary Completion (Estimated)

July 4, 2024

Study Completion (Estimated)

July 4, 2024

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HÜ- FTR- BD- 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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