Evaluation of Deterioration in Body Posture of Older Patients During Gait Compared to Stance

University Medical Centre Ljubljana

Status: Completed

Conditions: Sagittal Balance; Degenerative Spine Disease

Treatments: Diagnostic Test: Muscle strength and body composition measurement; Diagnostic Test: Questionnaires and pain assessment; Diagnostic Test: Standing sagittal whole spine X-ray; Diagnostic Test: Dynamic test

Study type: Observational

Funder types: Other

Identifiers

NCT06557837

AOS-Startup-23-028 (Other Grant/Funding Number)

0120-22/2023/47

Details and patient eligibility

About

The goal of this observational study is to analyze how spinal alignment changes when walking compared to standing still in adults aged 50 to 80 years who have sagittal imbalance. The main questions we aim to answer are:

1. Do patients with radiological parameters indicative of sagittal imbalance experience a statistically significant deterioration in sagittal balance during walking compared to a control group?
2. Do radiographs taken after six minutes of walking provide comparable results to dynamic measurements during the walking test?
3. Do patients with a greater deterioration in sagittal balance during walking show poorer clinical self-assessment scores?
4. Is there a significant correlation between parameters obtained using established diagnostic methods and the degree of sagittal balance deterioration during walking?

Participants will be divided into two groups: patients with radiological indicators of sagittal imbalance and a control group of healthy individuals with back pain of similar age. Participants will:

1. Complete questionnaires about their back pain and mobility.
2. Have X-ray images taken of their spine before and after walking for six minutes.
3. Undergo muscle strength tests and gait analysis using motion capture and electromyography (EMG) to monitor muscle activity while walking.

Enrollment: 64 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pelvic incidence-lumbar lordosis deficit (PI-LL) greater than 10 or sagittal vertical axis (SVA) greater than 4 centimeters
• The main symptom is low back pain
• Age between 50-80 years.

Exclusion criteria

• Symptoms of spinal stenosis
• Previous instrumented spinal surgery
• Cobb angle greater than 30°
• Symptoms of hip or knee arthrosis
• Symptoms of vascular intermittent claudication
• Cardio-pulmonary disease that lowers the patient's physical capability
• Neuromuscular disease

Trial design

64 participants in 2 patient groups

Patients with sagittal imbalance

Description:

Patients that have pelvic incidence-lumbar lordosis deficit (PI-LL) greater than 10 or sagittal vertical axis (SVA) greater than 4 centimetres on X-ray imaging.

Treatment:

Diagnostic Test: Dynamic test

Diagnostic Test: Standing sagittal whole spine X-ray

Diagnostic Test: Questionnaires and pain assessment

Diagnostic Test: Muscle strength and body composition measurement

Control group

Description:

Participants with normal pelvic incidence-lumbar lordosis deficit (PI-LL) and sagittal vertical axis (SVA) on X-ray imaging.

Treatment:

Diagnostic Test: Dynamic test

Diagnostic Test: Standing sagittal whole spine X-ray

Diagnostic Test: Questionnaires and pain assessment

Diagnostic Test: Muscle strength and body composition measurement

Sponsor of this trial

Lead Sponsor

University Medical Centre Ljubljana

Collaborating Sponsor

AO Foundation, AO Spine