RecruitingNot ApplicableNCT04812730

Multimodal Bio-mechanical Analysis of Adult Spinal Deformity With Sagittal Plane Misalignment


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

265 participants

Start Date

Jan 1, 2016

Study Type

INTERVENTIONAL

Conditions

Summary

A good understanding of the principles of balance is vital to achieve optimal outcomes when treating spinal disorders. A complex interaction of the neuromotor system and muscular recruitment is necessary for ergonomic balance and deliberate displacement of the human body. Sagittal plane misalignment in spinal deformities challenges balance mechanisms used for maintenance of an upright posture. The occurrence of postoperative complications after spinal deformity correction like under-correction of sagittal misalignment, postoperative reciprocal changes in thoracic kyphosis, proximal junctional kyphosis and failure of instrumentation are possibly due to the current state-of-the art inadequate diagnostic work-up. Investigators do not fully understand the roll of vision and exact strategy of recruitment of neuromuscular units (trunk, pelvis, lower limbs) in patients with sagittal plane misalignment during standing and walking. To understand this, a dynamic evaluation of individuals with spinal deformities is needed. Currently there is only very little research performed in the field of clinical balance tests and instrumented movement analysis in patients with spinal deformity. The challenge for future studies is to further unravel the relation between trunk and lower limb movements, grouped into functional movement patterns. Moreover, additional information on trunk and lower limb kinetics and muscle activity (using dynamic electromyography (EMG)) will highly contribute to the understanding of this functional relationship, and will provide more in-depth insights into compensatory mechanisms of the trunk versus the lower limbs and vice versa.


Eligibility

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is analyzing how spinal deformity — abnormal curvature or alignment of the spine in adults — affects movement, balance, and quality of life using a combination of motion capture analysis, force plates, and muscle activity measurements. Adult spinal deformity can cause significant pain, reduced walking ability, and postural imbalance. Understanding the biomechanics of these patients helps surgeons plan better treatments and set realistic expectations. The study includes two groups: adults with confirmed spinal deformity (pathological group) and healthy adults without spinal problems (control group). Both groups undergo gait analysis and complete questionnaires at multiple time points. You may be eligible if: - You are 45 years or older - Pathological group: You have adult spinal deformity (congenital, degenerative, idiopathic, or iatrogenic) with measurable sagittal or coronal malalignment - Control group: You are healthy without spinal deformity and can walk 1,000 meters independently - You can walk at least 50 meters independently (pathological group) or 1,000 meters (control group) You may NOT be eligible if: - You are under 45 years old - Your BMI is over 30 (pathological group) or 27 (control group) - You have another neurological condition affecting balance (stroke, Parkinson's — except Parkinson's is allowed in pathological group) - You have severe hip, knee, or ankle arthritis or a significant leg length discrepancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHER2D versus 3D analysis of EOS stereo radiographic analysis

The use of EOS stereo radiographic analysis and health related quality of life scores to measure the distance of the center of acoustic meati in the transversal plane with respect to the gravity line

OTHERStatic versus dynamic analysis

The use of clinical postural tests and instrumented movement analysis to evaluate the importance of muscle fatigue and compensation mechanisms

OTHERPre- versus postoperative analysis

The use of EOS stereo radiographic imaging and motion analysis to understand the compensation mechanisms in trunk, pelvis and lower limbs and the correlation between primary and secondary mechanisms.

OTHERReliability of the dynamic evaluation

Repeated measurements of the different aspects of the dynamic evaluation protocol (strenght measurements of trunk muscles, balance evaluation and movement analysis) will serve to evaluate the test-retest reliability and intra-rater reliability of the different protocols


Locations(1)

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

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NCT04812730


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