Looking at balance and movement in adults with sagittal spinal misalignment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.