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NCT07170813
Effects of Different Hyperextension Braces on Spinal Mobility
NA trial testing Spinal hyperextension brace in Corset in 30 participants. Enrolling by invitation.
1 October 2025
Quick facts
| Lead sponsor | Mustafa Tahsin Ozer |
|---|---|
| Phase | NA |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 30 |
| Start date | 1 October 2025 |
| Primary completion | 1 October 2025 |
| Estimated completion | 30 August 2026 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Spinal hyperextension brace
Conditions studied
- Corset — all drugs for Corset →
- Spinal Mobility — all drugs for Spinal Mobility →
- Posture — all drugs for Posture →
Sponsor
Mustafa Tahsin Ozer
Who can join
Adults 18 to 35, any sex, with Corset or Spinal Mobility. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07170813 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mustafa Tahsin Ozer
- Last refreshed: 12 September 2025
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