Classification of the Sagittal Profile of the Spine in Asymptomatic Elderly Subjects
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Classification of Roussouly type
研究概览
简要总结
Principal aim The main purpose of the study is to describe the distribution of the sagittal profile in elderly subjects in order to bridge the gap present in this type of screening, evaluated in the literature for adults only (i.e. 160 subjects considered by Roussouly et al. in 2005). This classification assigns an integer value from 1 to 4 in relation to the evaluation of alignment of the lumbar spine and pelvis in the sagittal plane. The population description is therefore divided into four categories. The extension of this classification to elderly can provide useful support for the clinical evaluation and the specific treatment of the elderly patients.
Secondary aims The study aims in addition to evaluate the relation between the spine sagittal profile and the objective indexes obtained from the assessment of fall-risk and gait cycle analysis. Accordingly, a subgroup of 40 subjects out of the 160 will be evaluated. This subgroup will consider the subjects older than or equal to 74 years, where the risk of falling is most likely to be expected.
详细描述
Introduction:
The classification of spine sagittal profile can be an essential prediction factor for the specific prevention and treatment of patient's pathologies. Despite high variability, sagittal alignment can be accurately measured by radiographic examination and is fully replicable. To this regard, a classification of the lumbar profile and pelvis in the sagittal plane was proposed by Roussouly et al. Specifically, four different typologies can be recognized. These typologies classify the profile of the lumbar curve and are directly related to the quantification of the pelvic inclination. The study by Roussouly et al. examined 160 asymptomatic subjects aged between 18 and 45 years and confirmed the high inter-individual variability of the sagittal profile. Unfortunately, this classification has not been extended to elderly. In this regard, it has been shown that peculiar changes in the sagittal profile are particularly evident in aging, such as the advancement of the average sagittal axis and the tendency to decrease of the degree of lumbar lordosis.
According to that, extending the classification of the spine sagittal alignment in elderly results of prime importance. Furthermore, extending this classification will also provide useful information supporting the clinical evaluation and the specific treatment of elderly patients (e.g. better understanding the association between spine alignment and the development of degenerative alterations). In addition to this primary objective, this study aims to assess the relation between postural imbalance (due to alterations of the sagittal profile) and motor functionality in elderly. A subgroup of the enrolled subjects, equal to one quarter of the total size, will undergo fall-risk assessment and gait cycle analysis. This subgroup will account subjects older than or equal to 74 years, where the risk of falling is more likely to occur. The objective indices obtained from these analyses will be put in relation with the classification of the spine sagittal profile.
Aims of the study:
The primary aim of this study is to classify the spine sagittal profile in elderly asymptomatic subjects (older than or equal to 60 years) through the semi-automatic analysis of low dose radiographic images obtained through a validated radiographic system (EOS Imaging System, France). The study will evaluate 160 subjects, at least 40 of whom will have an age greater than or equal to 74 years. According to Roussouly et al., the classification of the spine alignment will assign an integer value ranging from 1 to 4, in relation to the evaluation of the lumbar spine and pelvis in the sagittal plane. Secondary aim of the study will be to investigate the relation between the classification of spine sagittal profile and the objective indexes characterizing the fall-risk and the gait cycle analysis. This assessment will take into account the subgroup of 40 subjects aged 74 years or more.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •older than or equal to 60 years
- •subscription of informed consent
排除标准
- •Significant painful episodes linked to the spine in the last 2 years
- •Early surgical interventions involving the spine
- •scoliosis or other spine pathologies (vertebral, neurological, muscular)
- •Obesity (BMI> 30 kg / m2)
研究组 & 干预措施
X-ray examination, fall-risk and gait
simultaneous acquisition in upright position of two full-body radiographic images, one in the coronal plane and one in the sagittal plane. In addition, 40 out of 160 subjects will undergo fall-risk assessment and gait cycle analysis evaluation.
干预措施: X-ray examination (Radiation)
X-ray examination, fall-risk and gait
simultaneous acquisition in upright position of two full-body radiographic images, one in the coronal plane and one in the sagittal plane. In addition, 40 out of 160 subjects will undergo fall-risk assessment and gait cycle analysis evaluation.
干预措施: fall-risk assessment (Other)
X-ray examination, fall-risk and gait
simultaneous acquisition in upright position of two full-body radiographic images, one in the coronal plane and one in the sagittal plane. In addition, 40 out of 160 subjects will undergo fall-risk assessment and gait cycle analysis evaluation.
干预措施: gait cycle analysis (Other)
结局指标
主要结局
Classification of Roussouly type
时间窗: Through study completion, an average of 18 months
This classification assigns an integer value ranging from 1 to 4, in relation to the evaluation of lumbar spine and pelvis alignment in the sagittal plane. It will be acquired to describe subjects' population, and correlations with fall-risk and gait cycle indexes will be checked for.
Subject's weight
时间窗: Through study completion, an average of 18 months
Subject's weight (kg) will be acquired to describe subjects' population
Subject's height
时间窗: Through study completion, an average of 18 months
Subject's height (cm) will be acquired to describe subjects' population
Pelvic incidence
时间窗: Through study completion, an average of 18 months
Pelvic incidence (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
Thoracic kyphosis
时间窗: Through study completion, an average of 18 months
Thoracic kyphosis (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
Lumbar lordosis
时间窗: Through study completion, an average of 18 months
Lumbar lordosis (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
Sacral slope
时间窗: Through study completion, an average of 18 months
Sacral slope (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
Pelvic tilt
时间窗: Through study completion, an average of 18 months
Pelvic tilt (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
Lateral pelvic inclination
时间窗: Through study completion, an average of 18 months
Lateral pelvic inclination (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
Pelvic torsion
时间窗: Through study completion, an average of 18 months
Pelvic torsion (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
次要结局
- Gait analysis: maximum hip extension(Through study completion, an average of 18 months)
- Gait analysis: maximum hip flexion moment(Through study completion, an average of 18 months)
- Gait analysis: maximum hip extension moment(Through study completion, an average of 18 months)
- Functional forward flexion(Through study completion, an average of 18 months)
- CoP sway area(Through study completion, an average of 18 months)
- Gait analysis: stance phase(Through study completion, an average of 18 months)
- Fall-risk score(Through study completion, an average of 18 months)
- Gait analysis: swing phase(Through study completion, an average of 18 months)
- Gait analysis: stride length(Through study completion, an average of 18 months)
- Gait analysis: average walking speed(Through study completion, an average of 18 months)
- Gait analysis: average step cadence(Through study completion, an average of 18 months)
- Gait analysis: maximum hip flexion(Through study completion, an average of 18 months)