Actively Recruiting

Phase Not Applicable
Age: 18Years - 79Years
All Genders
Healthy Volunteers
NCT04812730

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

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-03-13

265

Participants Needed

1

Research Sites

674 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 79Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 45 years or older
  • Diagnosis of adult congenital, degenerative, idiopathic, or iatrogenic spinal deformity (pathological group)
  • Mini Mental State Examination score of at least 25 out of 30 (pathological group)
  • Ability to walk at least 50 meters independently without a walking aid (pathological group)
  • Sagittal malalignment defined as pelvic incidence minus lumbar lordosis ≥ 25 degrees; sagittal vertical axis > 5 cm; pelvic tilt > 25°; thoracic kyphosis > 60°; and/or coronal malalignment with thoracic scoliosis ≥ 30 degrees; thoracolumbar/lumbar scoliosis ≥ 30 degrees; global coronal malalignment > 3 cm; posterior spinal fusion of more than 4 levels plus iliac fixation
  • Ability and willingness to attend follow-up visits and complete questionnaires
  • Completed informed consent
  • Age 45 years or older (control group)
  • No spinal deformity causing pathological sagittal alignment (control group)
  • Mini Mental State Examination score of at least 27 out of 30 (control group)
  • Ability to walk at least 1000 meters independently without a walking aid (control group)
  • Ability and willingness to attend follow-up visits and complete questionnaires (control group)
  • Completed informed consent (control group)
Not Eligible

You will not qualify if you...

  • Age under 45 years
  • No adult spinal deformity (pathological group)
  • Mini Mental State Examination score less than 25 out of 30 (pathological group)
  • Unable to walk at least 50 meters independently, with or without a walking aid (pathological group)
  • Missing informed consent
  • Neurological diseases affecting balance other than Parkinson's disease, such as stroke or vestibular lesions
  • Current musculoskeletal disorders of trunk or lower limbs affecting motor performance, including severe hip, knee, or ankle arthrosis, or leg length discrepancy greater than 3 cm
  • Body mass index (BMI) over 30 (pathological group)
  • Back pain and/or sciatica at time of study (control group)
  • Presence of adult spinal deformity causing pathological sagittal alignment (control group)
  • Mini Mental State Examination score less than 27 out of 30 (control group)
  • Unable to walk at least 1000 meters independently without a walking aid (control group)
  • Neurological diseases affecting balance such as stroke, Parkinson's disease, or vestibular lesions (control group)
  • Current musculoskeletal disorders of trunk or lower limbs affecting motor performance, including severe hip, knee, or ankle arthrosis, or leg length discrepancy greater than 3 cm (control group)
  • Body mass index (BMI) over 27 (control group)

AI-Screening

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Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

Actively Recruiting

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Research Team

L

Lieven Moke

CONTACT

L

Lennart Scheys

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

4

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