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

NCT04812730 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

  • Spinal Deformity

Interventions

OTHER

2D 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

OTHER

Static versus dynamic analysis

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

OTHER

Pre- 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.

OTHER

Reliability 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

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Lieven Moke · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04812730 on ClinicalTrials.gov