NCT04642456 Balance Assessment Scale and Strength Measurement Protocol to Measure Functionality in Adults With Spinal Deformity
| NCT ID | NCT04642456 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Spinal Deformity |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-05-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2021-05-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Develop reliable methods for functional assessment, for trunk strength, of Adult Spinal Deformity (ASD) patients and create a first clinical and normative database 1. Compare functionality of ASD and control subjects 2. Relate functionality of ASD patients to their pathology, in terms of spinal deformity and muscle condition
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)
Contact & Investigator
Lieven Moke
PRINCIPAL INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Frequently Asked Questions
Who can join the NCT04642456 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Spinal Deformity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04642456 currently recruiting?
Yes, NCT04642456 is actively recruiting participants. Contact the research team at lieven.moke@uzleuven.be for enrollment information.
Where is the NCT04642456 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT04642456 clinical trial?
NCT04642456 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Lieven Moke at Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 30 participants.