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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Pathological group

Age >= 45 years

Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity

Scoring at least 25 out of 30 on Mini Mental State Examination

Disqualifiers

Pathological group

Age < 45 years old

Absence of adult spinal deformity

Scoring less than 25 out of 30 on Mini Mental State Examination

Trial design

Design model

Single group

Treatments tested in this trial

  • 2D versus 3D analysis of EOS stereo radiographic analysis

    Other intervention

    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

  • Static versus dynamic analysis

    Other intervention

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

  • Pre- versus postoperative analysis

    Other intervention

    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.

  • Reliability of the dynamic evaluation

    Other intervention

    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

Treatment groups

265 Participants
are divided into 4 treatment groups
Group A: ASD with decompensated sagittal misalignmentOther 4 interventions
Group B: ASD with compensated sagittal misalignmentOther 4 interventions
Group C: ASD without sagittal misalignmentOther 4 interventions
Group D: Control groupOther 3 interventions

Trial outcomes

Primary outcomes

1

Health-Related Quality of Life (HRQL) score

To evaluate the domains related to physical, mental, emotional, and social functioning

Time frame
up to 2 years
2

Postoperative state of the art radiographic evaluation (EOS/CT)

To investigate whether a state of the art correction of a spinal deformity causes a change in the dynamic function of the individual

Time frame
up to 2 years
3

Postoperative state of the art radiographic evaluation (EOS/CT) in correlation with HRQL

To investigate the correlation of radiographic evaluation with HRQL

Time frame
up to 2 years
4

3D motion analysis and balance tests

3D motion analysis and balance tests are combined to investigate the correlation with the static EOS stereo radiographic evaluation/CT/MRI

Time frame
up to 2 years

Secondary outcomes

1

Falls Efficacy Scale-International (FES-I)

To measure the concerns about falling

Time frame
up to 2 years
2

EuroQol-5D-3L

To evaluate mobility, self-care, daily activities, pain / discomfort and anxiety / depression

Time frame
up to 2 years
3

Mini-Mental State Examination (MMSE)

To evaluate cognitive functions: attention and orientation, memory, registration, recollection, calculation, language and praxis.

Time frame
up to 2 years
4

Karnofsky Performance Score (KPS)

To determine the ability of patient to tolerate therapies in illness. The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death.

Time frame
up to 2 years

Other outcomes

Sponsors and contacts

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