NCT06557837

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Degenerative Spine Disease
• Sagittal Balance

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Questionnaires and pain assessment	Participants complete two questionnaires: the Oswestry Disability Index (ODI) and the EQ-5D-5L. They also rate their low back pain using the Visual Analogue Score (VAS) scale and respond to two additional questions about their posture and gait.
DIAGNOSTIC_TEST	Standing sagittal whole spine X-ray	Participants undergo standard preoperative X-ray imaging of the entire spine to capture the upright posture. This imaging is conducted before and after 6-minute of continuous walking to compare changes in spino-pelvic and sagittal balance parameters.
DIAGNOSTIC_TEST	Dynamic test	With the dynamic test, we analyze body movements of participants during gait using 49 reflective markers placed on their bodies according to the Qualisys PAF package: Instituti Ortopedici Rizzoli (IOR) and 10 EMG electrodes on specific leg and back muscles. Participants walk for 6 minutes between two cones set 7 meters apart, while a 12-camera Qualisys Motion Capture System tracks marker movements for comprehensive kinematic analysis. Data are recorded at five key moments: standing before and after the test, and during three phases of gait (at the beginning, middle, and end). Participants are barefoot and dressed in underwear for accurate measurement. Static recordings before and after walking involve stepping on a tensiometric force plate to measure the center of gravity. Before the test, participants perform stretching exercises to ensure consistent preparation.
DIAGNOSTIC_TEST	Muscle strength and body composition measurement	Participants have their body composition analyzed and the maximum isometric strength of their paraspinal and abdominal muscles measured using the Dr. Wolff BackCheck device.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2024-08-16
• Last updated: 2024-08-16

Locations

2 sites across 1 country: Slovenia