Measuring balance and trunk strength in adults with spinal deformity

Development and Reliability of a Balance Assessment Scale and Trunk Strength Measurement Protocol to Measure Functionality in Adults With Spinal Deformity

See if new balance tests and trunk-strength measurements can show functional differences between adults with spinal deformity and people without deformity.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 79 Years
• Sex: All
• Sponsor: Universitaire Ziekenhuizen KU Leuven (Academic / other)
• Locations: 1 site (Leuven, Vlaams-Brabant)
• Trial ID: NCT04642456 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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)

Where this trial is running

Leuven, Vlaams-Brabant

• UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)

Study contacts

• Principal investigator: Lieven Moke — Universitaire Ziekenhuizen KU Leuven
• Study coordinator: Lieven Moke

Conditions Spinal Deformity