Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT04642456
Eligibility Criteria:
Inclusion criteria pathological subjects:
1. Adult (\>18 years old) subjects suffering from a adult spinal deformity with sagittal or coronal plane misalignment diagnosed on EOS imaging.
2. Ability to walk at least 50 meters distance independently without a walking aid.
3. No documented neurological disease or vestibular lesion affecting balance nor a current history of musculoskeletal disorders of the lower extremities affecting motor performance.
Inclusion criteria control group:
1. Adults (\> 18 year old)
2. No current history of back pain and spinal deformity.
3. Ability to walk at least 1000 meters distance independently without a walking aid.
4. No documented neurological disease or vestibular lesion affecting balance nor a current history of musculoskeletal disorders of the lower extremities affecting motor performance.
Exclusion criteria ASD patients:
1. Age \< 18 years old and \> 79 years old
2. Absence of adult spinal deformity
3. Non-ability to walk at least 50 meters distance independently, with or without a walking aid.
4. Missing patient informed consent
5. Patients presenting with a neurological disease affecting balance other than Parkinson's disease such as stroke and/or Vestibular lesion
6. Patients with a history of spinal fusion surgery.
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)
Exclusion criteria control group:
1. Age \< 18 years old and \> 79 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. Non-ability to walk at least 1000 meters distance independently without a walking aid
5. Missing patient informed consent
6. Patients presenting with a neurological disease affecting balance such as Stroke, Parkinson's disease 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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT04642456
Study Brief:
Protocol Section:
NCT04642456