Measuring balance and trunk strength in adults with spinal deformity
Official title: Development and Reliability of a Balance Assessment Scale and Trunk Strength Measurement Protocol to Measure Functionality in Adults With Spinal Deformity
Run by Universitaire Ziekenhuizen KU Leuven · NCT04642456 · Data updated 2026-11-12
See if new balance tests and trunk-strength measurements can show functional differences between adults with spinal deformity and people without deformity.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 79 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Status | Recruiting |
| Started | May 1, 2021 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | March 9, 2026 |
| Trial ID | NCT04642456 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with a diagnosed adult spinal deformity who can walk at least 50 meters unaided and have no neurologic, vestibular, or lower-extremity musculoskeletal disorders are ideal candidates.
✕Probably not a fit
Patients who are non-ambulatory, have neurologic or vestibular disease, significant lower-extremity musculoskeletal disorders, or are outside the 18–79 age range are unlikely to qualify or receive benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study combines standardized trunk-strength tests and balance assessments with EOS stereoradiographic full-body imaging to capture 3D spinal alignment and muscle condition. Adults with diagnosed spinal deformity will be compared to control adults without back problems to build the first clinical and normative database for these measures. Researchers will relate functional test results to specific features of the spinal deformity and to muscle condition seen on imaging. The goal is to provide objective, dynamic 3D information that can inform future clinical decision-making for adult spinal deformity care.
Why it matters
Potential benefit: If successful, this could give clinicians objective 3D function data to better personalize treatment and help reduce common undesired surgical outcomes like postoperative shoulder imbalance.
How similar studies have gone: Prior work has applied EOS imaging and strength testing to spinal alignment, but integrating 3D dynamic functional measures into clinical decision-making for adult spinal deformity is relatively novel and not yet widely proven.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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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
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.