Looking at balance and movement in adults with sagittal spinal misalignment
Multimodal Bio-mechanical Analysis of Adult Spinal Deformity With Sagittal Plane Misalignment
This project will try using 3D imaging and motion analysis to see how adults aged 45+ with sagittal plane spinal misalignment stand and walk compared with people without deformity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 265 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT04812730 on ClinicalTrials.gov |
What this trial studies
Researchers will combine EOS stereo-radiography (3D imaging) with dynamic motion analysis and neuromuscular measurements to characterize how the trunk, pelvis, and lower limbs are recruited during standing and walking in adults with sagittal spinal misalignment. The protocol compares static 2D radiographs versus 3D EOS results, and static posture versus dynamic gait, including pre- and postoperative evaluations where applicable. Both a pathological group of symptomatic adults and an asymptomatic control group (age ≥45) will attend in-person testing at UZ Leuven for standardized imaging, motion capture, and questionnaire follow-up. The goal is to clarify mechanisms behind balance failure and postoperative complications so diagnostic work-ups can be improved.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45 or older with symptomatic adult spinal deformity and sagittal malalignment who can walk at least 50 meters independently, score ≥25 on the MMSE, and are willing to attend in-person follow-up visits.
Not a fit: People without sagittal plane deformity, those unable to walk independently, or individuals with significant cognitive impairment are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the work could lead to better diagnostic tests and surgical planning that reduce under-correction and postoperative alignment complications.
How similar studies have performed: Static radiographic measures like SVA and T1-SPI have been linked to outcomes in past work, but multimodal dynamic analyses combining EOS 3D imaging and motion capture remain relatively novel and not yet proven to change care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathological group 1. Age \>= 45 years 2. Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity 3. Scoring at least 25 out of 30 on Mini Mental State Examination 4. Ability to walk at least 50 meters distance independently without a walking aid 5. 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. 6. Ability and willingness of patient to attend follow-up visits and complete patient questionnaires 7. Completed patient informed consent * Control group 1. Asymptomatic adults not suffering from a spinal deformity leading to a pathological sagittal alignment presenting as volunteer in the University Hospitals Leuven, Belgium 2. Age \>=45 years old 3. Scoring at least 27 out of 30 on Mini Mental State Examination 4. Ability to walk at least 1000 meters distance independently without a walking aid 5. Ability and willingness of patient to attend follow-up visits and complete patient questionnaires 6. Completed patient informed consent Exclusion Criteria: * Pathological group 1. Age \< 45 years old 2. Absence of adult spinal deformity 3. Scoring less than 25 out of 30 on Mini Mental State Examination 4. Non-ability to walk at least 50 meters distance independently, with or without a walking aid. 5. Missing patient informed consent 6. Patients presenting with a neurological disease affecting balance other than Parkinson's disease such as stroke and/or Vestibular lesion 7. 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) 8. BMI\>30 * Control group 1. Age \< 45 years old 2. Backpain and/or Sciatica at time of the study 3. Presence of adult spinal deformity leading to a pathological sagittal alignment 4. Scoring less than 27 out of 30 on Mini Mental State Examination 5. Non-ability to walk at least 1000 meters distance independently without a walking aid 6. Missing patient informed consent 7. Patients presenting with a neurological disease affecting balance such as Stroke, Parkinson's disease and/or Vestibular lesion 8. 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) 9. BMI \> 27
Where this trial is running
Leuven, Vlaams-Brabant
- UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Lieven Moke — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Lieven Moke
- Email: lieven.moke@uzleuven.be
- Phone: +32 16 34 08 84
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.