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Clinical Trials/NCT06557837
NCT06557837
Completed
N/A

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

University Medical Centre Ljubljana2 sites in 1 country64 target enrollmentSeptember 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Degenerative Spine Disease
Sponsor
University Medical Centre Ljubljana
Enrollment
64
Locations
2
Primary Endpoint
Change in AM-STS During Gait
Status
Completed
Last Updated
last year

Overview

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. 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.
Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
May 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Armand Dominik Škapin

Principal Investigator

University Medical Centre Ljubljana

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in AM-STS During Gait

Time Frame: Within 2 months from enrollment

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.

Change in C7-STS During Gait

Time Frame: Within 2 months from enrollment

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.

Change in SVA on X-ray During Walking

Time Frame: At enrollment

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.

Change in CAM-HA on X-ray During Walking

Time Frame: At enrollment

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.

Secondary Outcomes

  • 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 GTA During Gait(Within 2 months from enrollment)
  • Change in TK on X-ray During Walking(At enrollment)
  • Additional Question: Does your body lean forward during gait?(At enrollment)
  • Change in STA During Gait(Within 2 months from enrollment)
  • Change in SS on X-ray During Walking(At enrollment)
  • Change in PT on X-ray During Walking(At enrollment)
  • Change in LL on X-ray During Walking(At enrollment)
  • Additional Question: Is it hard for you to stand upright?(At enrollment)
  • Maximum Isometric Strength of the Paraspinal Muscles(Within 2 months from enrollment)
  • Maximum Isometric Strength of the Abdominal Muscles(Within 2 months from enrollment)
  • Change in PI-LL on X-ray During Walking(At enrollment)
  • Change in OD-HA on X-ray During Walking(At enrollment)
  • Oswestry Disability Index (ODI) Questionnaire(At enrollment)
  • Change in Angle of the hip on X-ray During Walking(At enrollment)
  • Change in GT on X-ray During Walking(At enrollment)
  • EQ-5D-5L Questionnaire(At enrollment)
  • Visual Analogue Score (VAS) for low back pain(At enrollment)
  • Body Fat Mass(Within 2 months from enrollment)
  • Body Fat Percentage(Within 2 months from enrollment)
  • Skeletal Muscle Mass(Within 2 months from enrollment)
  • Total Body Water(Within 2 months from enrollment)
  • Extracellular Water / Total Body Water(Within 2 months from enrollment)

Study Sites (2)

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