Application in Rehabilitation of BHOHB SPINAL-METER and CervicalMeter for the Assessment of Posture in Patients With Dysmorphisms and Paramorphisms of the Spine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Cobb angle
研究概览
简要总结
The postural observation of the patient has an important role for the evaluation and monitoring of orthopedic and neurological degenerative pathologies. The study of the effects of rehabilitation in the treatment of postural alterations depends on the validity, sensitivity and specificity of the tool used.
The radiographic evaluation of the spine in the standard anteroposterior and lateral projections is the gold standard and provides a standardized and objective measure of the dysmorphisms and paramorphisms of the spine, although it requires exposure to X-rays and with costs of the method especially in the need to repeat the radiological examination in time.
Non-radiological tools for postural assessment have been proposed in the literature, with uncertain judgments by the various authors regarding their validity and reliability, due to the heterogeneity and poor quality of the studies in this regard.
The aim of this study is to evaluate the effectiveness of a new posture analysis methodology (BHOHB SPINAL-METER ® and CervicalMeter®) in measuring spine dysmorphisms and paramorphisms in adult patients affected by orthopedic and neurological degenerative pathologies, who carry out rehabilitation at the Policlinico Gemelli Foundation (FPG) Hospitalization and Rehabilitation Services clinic. In particular, the correspondence of radiological and clinical data with the reports obtained from the "BHOHB SPINAL-METER ® and CervicalMeter®" will be considered and the relationship between the data obtained with the two methods and the characteristics of pain, disability, balance and quality of life will be observed of patients suffering from orthopedic and neurological disease with dysmorphisms and paramorphisms of the spine, belonging to the rehabilitation clinic who agree to participate in the study.
详细描述
Setting: outpatients ward, UOSA( "Unità operativa semplice ambulatoriale" simple outpatient operating unit) Rehabilitation Service Hospitalization and FPG Rehabilitation Services.
Duration of the study: 1 year
Goals:
Primary endpoint: evaluation of the correlation of radiological and clinical reports with those obtained from the device under study; in particular, the measurement of the radiological Cobb angle (from standard X-ray in orthostatism, on a single plate in the anteroposterior projection) of the patient will be correlated with that evaluated with the BHOHB SPINAL-METER® and CervicalMeter® Secondary end point: evaluation of the effects of postural alteration measured radiologically and with the "BHOHB SPINAL-METER ® and CervicalMeter®" on static and dynamic balance, on spine pain and on the quality of life of patients, evaluated respectively with the measures Berg Balance scale, Tinetti Gait Evaluation, NRS (Numeric rating Scale) and with stabilometric examination, which are performed routinely in outpatient visits.
Calculation of the sample size: Based on the current literature on the results obtained via RX and on the data of the new instrument held by the investigators, in order to estimate a Pearson correlation coefficient equal to 0.90, with a width of the interval of 0.10 and a bilateral confidence interval of 95%, it is considered necessary to enroll a minimum number of patients equal to 62.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged > 18 years
- •MMSE >23
- •Subjects affected by orthopedic and neurological degenerative pathologies and with dysmorphisms or paramorphisms of the spine, capable of maintaining an upright position and ambulating without aids.
- •Signature of the informed consent
排除标准
- •Psychiatric pathologies,
- •Cognitive impairment (MMSE<23),
- •Inability to stand and walk.
- •Failure to sign the informed consent
结局指标
主要结局
Cobb angle
时间窗: This is a baseline evaluation. The study does not include further evaluations. We aimed to perform a one-time comparison of the Cobb's angle measured through BHOHB SPINAL-METER versus standard spinal radiography
radiographic angle measuring the degree of scoliosis in the frontal plane
次要结局
- NRS numeric rating scale for pain(This is a baseline evaluation. The study does not include further evaluations. NRS score goes from 0 to 10. Higher scores correspond to worse pain perception.)
- stabilometric test(This is a baseline evaluation. The study does not include further evaluations.)
- Berg Balance scale(This is a baseline evaluation. The study does not include further evaluations. The Berg balance scale score goes from 0 to 56 points. Higher scores indicate low/no balance deficit and low/no risk of falling.)
- Tinetti scale(This is a baseline evaluation. The study does not include further evaluations. The Tinetti scale score goes from 0 to 26. The higher scores indicate a lower risk of falls)