Effects of Different Hyperextension Braces on Spinal Mobility

Mustafa Tahsin Ozer

Status: Invitation-only

Conditions: Spinal Mobility; Posture; Corset

Treatments: Other: Spinal hyperextension brace

Study type: Interventional

Funder types: Other

Identifiers

NCT07170813

Yalova University

2024/4

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy young adults aged 18-35.
• Body mass index (BMI) between 18.5 and 24.9 kg/m2

Exclusion criteria

• 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.
• 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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Spinomed

Experimental group

Description:

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.

Treatment:

Other: Spinal hyperextension brace

Jewett

Experimental group

Description:

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.

Treatment:

Other: Spinal hyperextension brace