Spinal DeformityASDNCT04812730
Multimodal Bio-mechanical Analysis of Adult Spinal Deformity With Sagittal Plane Misalignment
A study testing 2D versus 3D analysis of EOS stereo radiographic analysis, Static versus dynamic analysis and Pre- versus postoperative analysis in people with Spinal Deformity, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Deformity
- What is being tested?
- 2D versus 3D analysis of EOS stereo radiographic analysis, Static versus dynamic analysis and Pre- versus postoperative analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2016to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Ability to walk at least 50 meters distance independently without a walking aid
- Sagittal malalignment: PI-LL ≥ 25 degrees; sagittal vertical axis >5cm; pelvic tilt >25° and/or thoracic kyphosis > 60° and/or coronal malalignment: thoracic scoliosis 30 ≥ degrees; thoracolumbar/lumbar scoliosis ≥ 30 degrees; global coronal malalignment >3cm, posterior spinal fusion > 4 levels + iliac fixation.
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- Ability and willingness of patient to attend follow-up visits and complete patient questionnaires
- Completed patient informed consent
- Control group
- Asymptomatic adults not suffering from a spinal deformity leading to a pathological sagittal alignment presenting as volunteer in the University Hospitals Leuven, Belgium
- Age >=45 years old
- Scoring at least 27 out of 30 on Mini Mental State Examination
- Ability to walk at least 1000 meters distance independently without a walking aid
- Ability and willingness of patient to attend follow-up visits and complete patient questionnaires
- Completed patient informed consent
Who cannot join
- Pathological group
- Age < 45 years old
- Absence of adult spinal deformity
- Scoring less than 25 out of 30 on Mini Mental State Examination
- Non-ability to walk at least 50 meters distance independently, with or without a walking aid.
- Missing patient informed consent
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- Patients presenting with a neurological disease affecting balance other than Parkinson's disease such as stroke and/or Vestibular lesion
- Patients with a current history of diagnosed musculoskeletal disorders of the trunk and/or lower extremities affecting the motor performance such as severe hip arthrosis with or without flexion contracture, severe knee arthrosis, severe ankle arthrosis, severe leg length discrepancy (> 3 cm)
- BMI>30
- Control group
- Age < 45 years old
- Backpain and/or Sciatica at time of the study
- Presence of adult spinal deformity leading to a pathological sagittal alignment
- Scoring less than 27 out of 30 on Mini Mental State Examination
- Non-ability to walk at least 1000 meters distance independently without a walking aid
- Missing patient informed consent
- Patients presenting with a neurological disease affecting balance such as Stroke, Parkinson's disease and/or Vestibular lesion
- Patients with a current history of diagnosed musculoskeletal disorders of the trunk and/or lower extremities affecting the motor performance such as severe hip arthrosis with or without flexion contracture, severe knee arthrosis, severe ankle arthrosis, severe leg length discrepancy (> 3 cm)
- BMI > 27
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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. Spinal alignment has to allow an individual to stand pain free with minimal muscular energy expenditure. This concept is reflected in the "Cone of Economy" principle by Jean Dubousset. Sagittal plane misalignment in spinal deformities challenges balance mechanisms used for maintenance of an upright posture. The current state of the art diagnostic work-up of spinal deformities is mainly a static 2D radiological evaluation in Scoliosis Research Society (SRS) free standing position with analysis of the spinopelvic parameters as described by Duval-Beaupmet and others.
Until now sagittal balance has been assessed by dropping a vertical plumb line from C7 vertebral body center and quantifying the distance of the sacral plate from this vertical (Sagittal Vertical Axis or SVA). Others measure the T1 spinopelvic inclination angle (T1-SPI). SVA, T1-SPI and pelvic tilt are correlated with self-reported disability and health related quality of life scores (HRQL) compared to age- and sex-related normal subjects.
Literature suggests a multifactorial etiology of impaired balance capacity with neurological or vestibular disease, muscular atrophy in mm erector spinae, increasing age, low back pain and history of spinal surgery. 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. Several compensatory mechanisms in sagittal balance disorders are identified in the static situation. Intra-spinal mechanisms like hyperextension of lumbar discs, retrolisthesis of lumbar vertebrae, reduction of thoracic kyphosis, and pelvic back tilt and extra-spinal mechanisms like knee flessum and ankle extension are suggested to act as compensatory mechanisms. In literature, a strong correlation between the occurrence of knee flessum and lack of lumbar lordosis is seen. To understand these mechanisms 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. With regard to clinical balance tests the Fullerton Advanced Balance Scale (FAB scale) is presented as a reliable tool to predict wether or not higher-functioning older adults will fall. The FAB scale is a reliable and valid tool in Parkinson disease with minimal ceiling effect and shows promising results in detecting small balance disturbances.The use of these balance tests in patients suffering from spinal deformity with sagittal imbalance has not been validated in literature till now. Last but not least the use of instrumented movement analysis to examen gait in subjects with spinal deformity is unconventional. Subjects with fixed sagittal balance are reported to have a significant slower walking speed and poorer endurance score relative to age matched controls. An inadequate use of pelvic tilt during walking is also observed. Subjects with forward inclination of the trunk present with abnormal kinematics and kinetics of the lower limbs during walking compared to age- and sex-related normal subjects. When deformity exceeds the primary compensation mechanisms, additional mechanisms, such as crouch gait, are used to reorient the trunk to a more vertical position.
The currently used trunk model in movement analysis in UZ Leuven has been developed by Heyrman et al after the work of Leardini et al. Armand et al also considered the thorax not as one rigid segment and presented the use of an optimal marker placement set on the thorax for clinical gait analysis. However they did not include markers on the head. Heyrman et al showed in their study with cerebral palsy children (CP) that increased altered trunk movements during gait were related to a lower performance on the Trunk Control Measurement Scale (TCMS) in sitting, indicating the presence of an underlying trunk control deficit. These authors were thus able to show a correlation between a clinical postural test like the TCMS and trunk-and lower limb parameters during gait. However, they could not find a significant correlation between overall altered trunk movements and altered lower limb movements during gait in a CP population and concluded that observed thorax movements during gait, most likely are the resultant of both compensatory movements for lower limb deficits and an underlying trunk control deficit. The current concept of thinking is that in an adult spinal deformity population with sagittal plane misalignment the observed altered movements in the lower limbs during standing and gait are compensatory for the forward inclination of the trunk. 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
- Being tested
- 2D versus 3D analysis of EOS stereo radiographic analysis, Static versus dynamic analysis, Pre- versus postoperative analysis, Reliability of the dynamic evaluation
- Keywords
- Sagittal plane misalignment, Trunk and lower limb, Motion analysis, EOS stereo radiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D versus 3D analysis of EOS stereo radiographic analysisOther
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 analysisOther
The use of clinical postural tests and instrumented movement analysis to evaluate the importance of muscle fatigue and compensation mechanisms
Pre- versus postoperative analysisOther
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 evaluationOther
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
| Study group | Role | What they receive |
|---|---|---|
| ASD with decompensated sagittal misalignment | Other | Adults suffering from a spinal deformity with a decompensated sagittal misalignment Receives: Other: 2D versus 3D analysis of EOS stereo radiographic analysis; Other: Static versus dynamic analysis; Other: Pre- versus postoperative analysis; Other: Reliability of the dynamic evaluation |
| ASD with compensated sagittal misalignment | Other | Adults suffering from a spinal deformity with a compensated sagittal misalignment Receives: Other: 2D versus 3D analysis of EOS stereo radiographic analysis; Other: Static versus dynamic analysis; Other: Pre- versus postoperative analysis; Other: Reliability of the dynamic evaluation |
| ASD without sagittal misalignment | Other | Adults suffering from a spinal deformity without a sagittal misalignment Receives: Other: 2D versus 3D analysis of EOS stereo radiographic analysis; Other: Static versus dynamic analysis; Other: Pre- versus postoperative analysis; Other: Reliability of the dynamic evaluation |
| Control group | Other | Asymptomatic adults not suffering from a spinal deformity Receives: Other: 2D versus 3D analysis of EOS stereo radiographic analysis; Other: Static versus dynamic analysis; Other: Reliability of the dynamic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life (HRQL) score
To evaluate the domains related to physical, mental, emotional, and social functioning
Measured: up to 2 years
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
Measured: up to 2 years
Postoperative state of the art radiographic evaluation (EOS/CT) in correlation with HRQL
To investigate the correlation of radiographic evaluation with HRQL
Measured: up to 2 years
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
Measured: up to 2 years
3D motion analysis and balance tests to investigate the dynamic function
3D motion analysis and balance tests are combined to investigate whether a state of the art correction of a spinal deformity causes a change in the dynamic function of the individual
Measured: up to 2 years
3D motion analysis and balance tests in correlation with HRQL
3D motion analysis and balance tests are combined to investigate the correlation with HRQL (Health-Related Quality of Life)
Measured: up to 2 years
Static EOS stereo radiographic evaluation
To investigate whether a state of the art correction of a spinal deformity causes a change in the dynamic function of the individual
Measured: up to 2 years
Physical activity
Physical activity will be measured using a step counter (Garmin, Vivofit 4), which is a feasible and reliable parameter to measure physical activity in spinal surgery patients up to one-year post-op
Measured: up to 2 years
Secondary outcomes (5)
Falls Efficacy Scale-International (FES-I)
To measure the concerns about falling
Measured: up to 2 years
EuroQol-5D-3L
To evaluate mobility, self-care, daily activities, pain / discomfort and anxiety / depression
Measured: up to 2 years
Mini-Mental State Examination (MMSE)
To evaluate cognitive functions: attention and orientation, memory, registration, recollection, calculation, language and praxis.
Measured: up to 2 years
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.
Measured: up to 2 years
Cumulative Illness Rating Scale
To determine the presence of comorbidities. The scale format provides for 13 relatively independent areas grouped under body systems. Ratings are made on a 5-point "degree of severity" scale, ranging from "none" to "extremely severe".
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study startJan 2016
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DeformityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lieven Moke, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812730
- Sponsor's protocol ID
- S58082
- Acronym
- ASD
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2021
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No