CorsetNCT07170813
Effects of Different Hyperextension Braces on Spinal Mobility
A study testing Spinal hyperextension brace in people with Corset and Spinal Mobility, run by Mustafa Tahsin Ozer at 1 site in Turkey (Türkiye).
Trial summary
This project aims to investigate the effects of different hyperextension braces (Jewett and Spinomed) on spinal mobility and posture. Hyperextension braces are commonly prescribed to limit spinal flexion and regulate load distribution, especially in cases of spinal injuries and postural disorders. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Corset, Spinal Mobility, Posture
- What is being tested?
- Spinal hyperextension brace
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young adults aged 18-35.
- Body mass index (BMI) between 18.5 and 24.9 kg/m2
Who cannot join
- Having experienced pain, discomfort, or discomfort in the upper back, waist, or lower extremities in the last 4 weeks on the Nordic Musculoskeletal System Questionnaire.
- A score above 20 on the Oswestry Disability Questionnaire.
- Having a condition related to spinal malalignment identified by a specialist physician (such as scoliosis, hyperkyphosis, hypokyphosis, Schuerman's kyphosis).
- Having a history of congenital hip dislocation.
- Having had surgery on the lower extremities or spine.
- Having a neurological disease or medication use that could cause balance loss.
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- Having engaged in regular exercise in the last 6 months.
- Having a history of regular brace use in the last 6 months.
- Having a rheumatic disease affecting the axial skeleton.
- Having a diagnosis of a disease related to the axial skeleton, such as spondylosis, spondylolisthesis, spinal stenosis, or disc herniation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Different Hyperextension Braces on Spinal Mobility
This project aims to investigate the effects of different hyperextension braces (Jewett and Spinomed) on spinal mobility and posture. Hyperextension braces are commonly prescribed to limit spinal flexion and regulate load distribution, especially in cases of spinal injuries and postural disorders. However, their objective impact on spinal biomechanics remains unclear.
Purpose and Scope The study will be conducted on 30 healthy participants aged 18-35.
Read more
Spinal mobility, posture, and movement analysis will be assessed using a dual inclinometer and the PostureScreen mobile application.
Evaluations will be performed under three conditions:
- Without a brace
- With a Jewett brace
- With a Spinomed brace (applied in randomized order)
Assessments will include four-direction spinal mobility and postural analysis during daily life activities such as standing, squatting, and single-leg stance.
Hypotheses H0: Hyperextension braces do not restrict spinal mobility. H1: Hyperextension braces restrict spinal mobility. H2: Hyperextension braces do not alter body alignment during movements. H3: Hyperextension braces alter body alignment during movements.
Methodology
The study is designed as a cross-sectional trial.
Each measurement will be repeated three times. Data will be analyzed statistically using ANOVA or Kruskal-Wallis tests depending on distribution.
Ethical approval has been obtained (Yalova University, Protocol No: 2024/4).
Expected Contributions Academic: Results are expected to be presented at the Congress of the International Society of Biomechanics (2025) and published in a high-impact Q1 journal such as Spine.
Clinical: Findings will provide objective data on the effectiveness of hyperextension braces, guiding clinicians and physiotherapists in brace selection.
Educational: The project will also contribute to the training of young researchers, offering hands-on experience in research design and execution
- Conditions
- Corset, Spinal Mobility, Posture
- Being tested
- Spinal hyperextension brace
- Keywords
- Posture, movement, biomechanics, corset, spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal hyperextension braceOther
The Jewett brace is a hyperextension spinal orthosis designed to limit spinal flexion and promote proper posture by applying anterior and posterior forces to the thoracolumbar spine. It is commonly used for spinal fractures, postural disorders, and to reduce spinal load. Participants will wear the Jewett brace during the intervention phase, and spinal mobility and posture will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Spinomed | Experimental | In this study, the effects of the Spinomed brace on spinal mobility will be evaluated. Participants will be fitted with the Spinomed brace for a defined period, and spinal range of motion will subsequently be assessed. Measurements will be performed using the dual inclinometer method, which provides an objective and reliable evaluation of spinal movements, including flexion, extension, lateral flexion, and rotation. The data obtained will be analyzed to determine the impact of the Spinomed brace on spinal mobility and to contribute to evidence-based clinical practice. Receives: Other: Spinal hyperextension brace |
| Jewett | Experimental | In this study, the effects of the Jewett brace on spinal mobility will be evaluated. Participants will be fitted with the Jewett brace for a defined period, and spinal range of motion will subsequently be assessed. Measurements will be performed using the dual inclinometer method, which provides an objective and reliable evaluation of spinal movements, including flexion, extension, lateral flexion, and rotation. The data obtained will be analyzed to determine the impact of the Jewett brace on spinal mobility and to contribute to evidence-based clinical practice. Receives: Other: Spinal hyperextension brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal Mobility (Range of Motion)
Sppinal ROM in flexion, extension, and lateral flexions will be measured using dual inclinometers to assess the impact of each brace.
Measured: 11 months
Secondary outcomes (1)
Postural Alignment Scores via PostureScreen App
Postural alignment will be assessed using the PostureScreen mobile application. Key parameters such as head shift, shoulder asymmetry, and thoracic kyphosis will be recorded to evaluate the impact of each brace condition.
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CorsetStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Tahsin Ozer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mustafa Tahsin Ozer, Izmir University of Economics
- Investigators
- Zeynep İclal Sag, Study director, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170813
- Sponsor's protocol ID
- 2024/4
- Other IDs
- Yalova University
- Status last verified
- Sep 2025
- First submitted
- 11 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Hyperextension Braces on Spinal Mobility
- ClinicalTrials.gov ID
- NCT07170813
- Acronym / sponsor ID
- 2024/4
- Conditions
- Corset, Spinal Mobility, Posture
- Keywords
- Posture, movement, biomechanics, corset, spine
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mustafa Tahsin OzerUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 12 Sep 2025 (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.
This project aims to investigate the effects of different hyperextension braces (Jewett and Spinomed) on spinal mobility and posture. Hyperextension braces are commonly prescribed to limit spinal flexion and regulate load distribution, especially in cases of spinal injuries and postural disorders. However, their objective impact on spinal biomechanics remains unclear.
Purpose and Scope The study will be conducted on 30 healthy participants aged 18-35.
Spinal mobility, posture, and movement analysis will be assessed using a dual inclinometer and the PostureScreen mobile application.
Evaluations will be performed under three conditions:
- Without a brace
- With a Jewett brace
- With a Spinomed brace (applied in randomized order)
Assessments will include four-direction spinal mobility and postural analysis during daily life activities such as standing, squatting, and single-leg stance.
Hypotheses H0: Hyperextension braces do not restrict spinal mobility. H1: Hyperextension braces restrict spinal mobility. H2: Hyperextension braces do not alter body alignment during movements. H3: Hyperextension braces alter body alignment during movements.
Methodology
The study is designed as a cross-sectional trial.
Each measurement will be repeated three times. Data will be analyzed statistically using ANOVA or Kruskal-Wallis tests depending on distribution.
Ethical approval has been obtained (Yalova University, Protocol No: 2024/4).
Expected Contributions Academic: Results are expected to be presented at the Congress of the International Society of Biomechanics (2025) and published in a high-impact Q1 journal such as Spine.
Clinical: Findings will provide objective data on the effectiveness of hyperextension braces, guiding clinicians and physiotherapists in brace selection.
Educational: The project will also contribute to the training of young researchers, offering hands-on experience in research design and execution
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinomed | Experimental | Other: Spinal hyperextension braceIn this study, the effects of the Spinomed brace on spinal mobility will be evaluated. Participants will be fitted with the Spinomed brace for a defined period, and spinal range of motion will subsequently be assessed. Measurements will be performed using the dual inclinometer method, which provides an objective and reliable evaluation of spinal movements, including flexion, extension, lateral flexion, and rotation. The data obtained will be analyzed to determine the impact of the Spinomed brace on spinal mobility and to contribute to evidence-based clinical practice. |
| Jewett | Experimental | Other: Spinal hyperextension braceIn this study, the effects of the Jewett brace on spinal mobility will be evaluated. Participants will be fitted with the Jewett brace for a defined period, and spinal range of motion will subsequently be assessed. Measurements will be performed using the dual inclinometer method, which provides an objective and reliable evaluation of spinal movements, including flexion, extension, lateral flexion, and rotation. The data obtained will be analyzed to determine the impact of the Jewett brace on spinal mobility and to contribute to evidence-based clinical practice. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy young adults aged 18-35.
- Body mass index (BMI) between 18.5 and 24.9 kg/m2
Key exclusion criteria (10 listed)
- Having experienced pain, discomfort, or discomfort in the upper back, waist, or lower extremities in the last 4 weeks on the Nordic Musculoskeletal System Questionnaire.
- A score above 20 on the Oswestry Disability Questionnaire.
- Having a condition related to spinal malalignment identified by a specialist physician (such as scoliosis, hyperkyphosis, hypokyphosis, Schuerman's kyphosis).
- Having a history of congenital hip dislocation.
- Having had surgery on the lower extremities or spine.
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 |
|---|---|---|
| Spinal hyperextension braceThe Jewett brace is a hyperextension spinal orthosis designed to limit spinal flexion and promote proper posture by applying anterior and posterior forces to the thoracolumbar spine. It is commonly used for spinal fractures, postural disorders, and to reduce spinal load. Participants will wear the Jewett brace during the intervention phase, and spinal mobility and posture will be assessed. | Other | Jewett, Spinomed |
Primary outcome
Spinal Mobility (Range of Motion)
Time frame: 11 months
Sppinal ROM in flexion, extension, and lateral flexions will be measured using dual inclinometers to assess the impact of each brace.
1 secondary outcome
Postural Alignment Scores via PostureScreen App
Time frame: 11 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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.
Zeynep İclal Sag study director
University of Yalova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal hyperextension brace in people with Corset and Spinal Mobility, run by Mustafa Tahsin Ozer at 1 site in Turkey (Türkiye).
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 2 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal Mobility (Range of Motion) (time frame: 11 months). 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 12 Sep 2025.