Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT06012032
Status:
UNKNOWN
Last Update Posted:
2023-08-25
First Post:
2023-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of BHOHB SPINAL-METER and CervicalMeter for Posture Assessment
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Study Overview
Official Title:
Application in Rehabilitation of BHOHB SPINAL-METER and CervicalMeter for the Assessment of Posture in Patients With Dysmorphisms and Paramorphisms of the Spine
Status:
UNKNOWN
Status Verified Date:
2023-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BHOHB
Brief Summary:
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.
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.
Detailed Description:
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.
Statistical analysis: Qualitative variables will be described through absolute frequencies and percentages, while quantitative variables as mean and standard deviation or median and interquartile range according to their distribution, which will be tested through the Shapiro-Wilk test.
The evaluation of the degree of correlation between the measurement of the radiological Cobb angle of the patient with that evaluated with the BHOHB SPINAL-METER ® and CervicalMeter® will be performed by calculating the Pearson correlation coefficient, and further exemplified by suitable scatter plots.
The effects of postural alteration measured radiologically and with the BHOHB SPINAL-METER ® and CervicalMeter®, on static and dynamic balance, spine pain and patients' quality of life will be analyzed through univariate and multivariate linear regression models.
A p-value \<0.05 will be considered statistically significant. The statistical analyzes will be performed using the STATA 16 software.
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.
Statistical analysis: Qualitative variables will be described through absolute frequencies and percentages, while quantitative variables as mean and standard deviation or median and interquartile range according to their distribution, which will be tested through the Shapiro-Wilk test.
The evaluation of the degree of correlation between the measurement of the radiological Cobb angle of the patient with that evaluated with the BHOHB SPINAL-METER ® and CervicalMeter® will be performed by calculating the Pearson correlation coefficient, and further exemplified by suitable scatter plots.
The effects of postural alteration measured radiologically and with the BHOHB SPINAL-METER ® and CervicalMeter®, on static and dynamic balance, spine pain and patients' quality of life will be analyzed through univariate and multivariate linear regression models.
A p-value \<0.05 will be considered statistically significant. The statistical analyzes will be performed using the STATA 16 software.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: