ScoliosisNCT06341465
Investigation of the Effects of Exercise and Kinesiological Taping on Spinal Deformities and Serum Markers in Individuals With Scoliosis
A study testing Just Exercise, Exercise and Taping in people with Scoliosis and Scoliosis Idiopathic, run by Hacettepe University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis, Scoliosis Idiopathic, Musculoskeletal Deformity
- What is being tested?
- Just Exercise, Exercise and Taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- 4 Apr 2024to 4 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 21 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The individuals who agree to the study conditions and will continue with the treatment protocol.
- 18-21 years
- Individuals with scoliosis
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Scoliosis, Scoliosis Idiopathic, Musculoskeletal Deformity
- Being tested
- Just Exercise, Exercise, Taping
- Keywords
- Scoliosis, Exercise
- Medical subject headings
- Scoliosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Just ExerciseOther
Schroth exercises are including rotational breathing, correction techniques, positioning, mobilization, and three-dimensional exercises specific to their curvature.
ExerciseOther
Schroth exercises are including rotational breathing, correction techniques, positioning, mobilization, and three-dimensional exercises specific to their curvature.
TapingOther
Kinesiological taping will be applied as a tone enhancer or tone reducer according to the the concave and convex sides of the curve.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | For 12 weeks, participants will receive rotational breathing, correction techniques, positioning, mobilization, and three-dimensional exercises specific to their curvature twice a week. Receives: Other: Just Exercise |
| Exercise and taping group | Experimental | 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. Receives: Other: Exercise; Other: Taping |
| Healthy people | No intervention | Healthy individuals without scoliosis will be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk rotation
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.
Measured: At the beginning of the study and three months later
Cobb angles
At the beginning and end of the study, participants will have their Cobb angle evaluated from anterior-posterior and posterior-anterior X-ray images.
Measured: At the beginning of the study and three months later
Serum markers
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.
Measured: At the beginning of the study and three months later
Secondary outcomes (2)
Quality of life with scoliosis people
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.
Measured: At the beginning of the study and three months later
Body image assessment
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.
Measured: At the beginning of the study and three months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start4 Apr 2024 (estimated)
- Primary completion4 Jul 2024 (estimated)
- Study completion4 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups. Schroth exercise group (n=19), schroth exercise and kinesiological taping group (n=19), healthy people (n=19).
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgül Dıngırdan, Sakarya Applied Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341465
- Sponsor's protocol ID
- HÜ- FTR- BD- 3
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Exercise and Kinesiological Taping on Spinal Deformities
- ClinicalTrials.gov ID
- NCT06341465
- Acronym / sponsor ID
- HÜ- FTR- BD- 3
- Conditions
- Scoliosis, Scoliosis Idiopathic, Musculoskeletal Deformity
- Keywords
- Scoliosis, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 4 Apr 2024 (estimated)
- Primary completion
- 4 Jul 2024 (estimated)
- Study completion
- 4 Jul 2024 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 groups. Schroth exercise group (n=19), schroth exercise and kinesiological taping group (n=19), healthy people (n=19).
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Just ExerciseFor 12 weeks, participants will receive rotational breathing, correction techniques, positioning, mobilization, and three-dimensional exercises specific to their curvature twice a week. |
| Exercise and taping group | Experimental | Other: Exercise, Other: TapingFor 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. |
| Healthy people | No intervention | –Healthy individuals without scoliosis will be included. |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The individuals who agree to the study conditions and will continue with the treatment protocol.
- 18-21 years
- Individuals with scoliosis
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Just ExerciseSchroth exercises are including rotational breathing, correction techniques, positioning, mobilization, and three-dimensional exercises specific to their curvature. | Other | Exercise group |
| ExerciseSchroth exercises are including rotational breathing, correction techniques, positioning, mobilization, and three-dimensional exercises specific to their curvature. | Other | Exercise and taping group |
| TapingKinesiological taping will be applied as a tone enhancer or tone reducer according to the the concave and convex sides of the curve. | Other | Exercise and taping group |
Primary outcome
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.
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.
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.
2 secondary outcomes
Quality of life with scoliosis people
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Just Exercise, Exercise and Taping in people with Scoliosis and Scoliosis Idiopathic, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birgül Dıngırdan, Masters degree (05444694932, birguldingirdan@subu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk rotation (time frame: At the beginning of the study and three months later). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.