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

NCT06557837 | Completed

• 2 other identifiers: 0120-22/2023/47AOS-Startup-23-028
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 2

Brief 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. 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. 2.Do radiographs taken after six minutes of walking provide comparable results to dynamic measurements during the walking test?
3. 3.Do patients with a greater deterioration in sagittal balance during walking show poorer clinical self-assessment scores?
4. 4.Is there a significant correlation between parameters obtained using established diagnostic methods and the degree of sagittal balance deterioration during walking?
5. 5.Complete questionnaires about their back pain and mobility.
6. 6.Have X-ray images taken of their spine before and after walking for six minutes.
7. 7.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

Outcome Measures

Primary Outcomes (4)

• Change in C7-STS During Gait

  The change in the value of the C7 - sagittal trunk shift (C7-STS) will be measured at five points during the dynamic test. The measurement is in millimeters. C7-STS is defined as the distance between vertical line through the marker placed on spinous process C7 and the marker on spinous process L5.

  Within 2 months from enrollment

• Change in AM-STS During Gait

  The change in the value of the Auditory meatus - sagittal trunk shift (AM-STS) will be measured at five points during the dynamic test. The measurement is in millimeters. AM-STS is defined as the distance between vertical line through the middle of the markers placed on each side of the head just above the ear and the middle of the markers placed on both greater trochanters.

  Within 2 months from enrollment

• Change in SVA on X-ray During Walking

  A comparison of the Sagittal Vertical Axis (SVA) in an upright stance, as captured by X-ray imaging, before and after 6 minutes of continuous walking. The measurement is in millimeters. SVA is measured as the horizontal distance between a vertical line from the center of the C7 vertebra and the posterior superior corner of the sacrum on a sagittal X-ray.

  At enrollment

• Change in CAM-HA on X-ray During Walking

  A comparison of the Center of Auditory Meatus to Hip Axis Plumbline (CAM-HA) in an upright stance, as captured by X-ray imaging, before and after 6 minutes of continuous walking. The measurement is in millimeters. CAM-HA is measured as the horizontal distance between a vertical line from the center of auditory meatus and the axis of the femoral heads on a sagittal X-ray.

  At enrollment

Secondary Outcomes (25)

• Change in PA During Gait

  Within 2 months from enrollment

• Change in LLA During Gait

  Within 2 months from enrollment

• Change in TKA During Gait

  Within 2 months from enrollment

• Change in STA During Gait

  Within 2 months from enrollment

• Change in GTA During Gait

  Within 2 months from enrollment

Study Arms (2)

Patients with sagittal imbalance

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.

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

Control group

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

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

Interventions

Questionnaires and pain assessment DIAGNOSTIC_TEST

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.

Control group; Patients with sagittal imbalance

Standing sagittal whole spine X-ray DIAGNOSTIC_TEST

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.

Control group; Patients with sagittal imbalance

Dynamic test DIAGNOSTIC_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.

Control group; Patients with sagittal imbalance

Muscle strength and body composition measurement DIAGNOSTIC_TEST

Participants have their body composition analyzed and the maximum isometric strength of their paraspinal and abdominal muscles measured using the Dr. Wolff BackCheck device.

Control group; Patients with sagittal imbalance

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are selected from the outpatient clinic at the specialized orthopedic department of the University Medical Centre Ljubljana.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• AO Foundation, AO Spine: collaborator

Study Sites (2)

Faculty of Sport, University of Ljubljana

Ljubljana, 1000, Slovenia

Location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Interventions

Pain Measurement; Muscle Strength

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 16, 2024
• Study Start: September 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SL (2)