Evaluation of Deterioration in Body Posture of Older Patients During Gait Compared to Stance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in AM-STS During Gait
研究概览
简要总结
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:
- Do patients with radiological parameters indicative of sagittal imbalance experience a statistically significant deterioration in sagittal balance during walking compared to a control group?
- Do radiographs taken after six minutes of walking provide comparable results to dynamic measurements during the walking test?
- Do patients with a greater deterioration in sagittal balance during walking show poorer clinical self-assessment scores?
- 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:
- Complete questionnaires about their back pain and mobility.
- Have X-ray images taken of their spine before and after walking for six minutes.
- Undergo muscle strength tests and gait analysis using motion capture and electromyography (EMG) to monitor muscle activity while walking.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in AM-STS During Gait
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Armand Dominik Škapin
Principal Investigator
University Medical Centre Ljubljana