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New treatment option for Spinal Deformity
Official title Multimodal Bio-mechanical Analysis of Adult Spinal Deformity With Sagittal Plane Misalignment
ClinicalTrials.gov ID: NCT04812730
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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 ≥...
- 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
- 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...
- 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...
- BMI \> 27
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Vlaams-Brabant, Belgium
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Vlaams-Brabant, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.