Status:
ACTIVE_NOT_RECRUITING
Multimodal Bio-mechanical Analysis of Adult Spinal Deformity With Sagittal Plane Misalignment
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Spinal Deformity
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief 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 necess...
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 necess...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT04812730
Start Date
January 1 2016
End Date
December 1 2028
Last Update
November 8 2024
Active Locations (1)
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1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000