Parkinson DiseaseBHOHBNCT06012032
Application of BHOHB SPINAL-METER and CervicalMeter for Posture Assessment
An observational study of Parkinson Disease and Osteoporosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Osteoporosis, Scoliosis
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 17 Feb 2022to 17 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients affected by dysmorphisms and paramorphisms of the spine due to degenerative orthopedic and neurological pathologies, who undergo rehabilitation at the FPG Hospitalization and Rehabilitation Services clinic.
Who may be able to join
- 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
Who cannot join
- Psychiatric pathologies,
- Cognitive impairment (MMSE<23),
- Inability to stand and walk.
- Failure to sign the informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Gianpaolo Ronconi
Roma, 00168
gianpaolo ronconi, 3477123940, gianpaolo.ronconi@unicatt.it
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Parkinson Disease, Osteoporosis, Scoliosis, Postural; Defect
- Medical subject headings
- Parkinson Disease, Osteoporosis, Scoliosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb angle
radiographic angle measuring the degree of scoliosis in the frontal plane
Measured: 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
Secondary outcomes (4)
Berg Balance scale
balance scale
Measured: 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
balance and deambulation scale
Measured: 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
NRS numeric rating scale for pain
visual analogical scale for pain assessment
Measured: 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
assessment of static balance
Measured: This is a baseline evaluation. The study does not include further evaluations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start17 Feb 2022
- Primary completion17 Feb 2024 (estimated)
- Study completion17 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- gianpaolo ronconi, Principal investigator, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012032
- Sponsor's protocol ID
- 4381
- Acronym
- BHOHB
- Status last verified
- Aug 2023
- First submitted
- 10 Mar 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc. 1986 Feb;34(2):119-26. doi: 10.1111/j.1532-5415.1986.tb05480.x. No abstract available.
PubMed 3944402Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.
PubMed 1468055EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
PubMed 10109801Cohen L, Kobayashi S, Simic M, Dennis S, Refshauge K, Pappas E. Non-radiographic methods of measuring global sagittal balance: a systematic review. Scoliosis Spinal Disord. 2017 Oct 3;12:30. doi: 10.1186/s13013-017-0135-x. eCollection 2017.
PubMed 29026895
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06012032
- Acronym / sponsor ID
- BHOHB / 4381
- Conditions
- Parkinson Disease, Osteoporosis, Scoliosis, Postural; Defect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 17 Feb 2024 (estimated)
- Study completion
- 17 Feb 2024 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by dysmorphisms and paramorphisms of the spine due to degenerative orthopedic and neurological pathologies, who undergo rehabilitation at the FPG Hospitalization and Rehabilitation Services clinic.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Psychiatric pathologies,
- Cognitive impairment (MMSE<23),
- Inability to stand and walk.
- Failure to sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cobb angle
Time frame: 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
4 secondary outcomes
Berg Balance scale
Time frame: 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
Time frame: 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
NRS numeric rating scale for pain
Time frame: 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
Time frame: This is a baseline evaluation. The study does not include further evaluations.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Background: PubMed 3944402Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc. 1986 Feb;34(2):119-26. doi: 10.1111/j.1532-5415.1986.tb05480.x. No abstract available.
- Background: PubMed 1468055Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.
- Background: PubMed 10109801EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
- Background: PubMed 29026895Cohen L, Kobayashi S, Simic M, Dennis S, Refshauge K, Pappas E. Non-radiographic methods of measuring global sagittal balance: a systematic review. Scoliosis Spinal Disord. 2017 Oct 3;12:30. doi: 10.1186/s13013-017-0135-x. eCollection 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
gianpaolo ronconi principal investigator
Catholic University of the Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Osteoporosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronconi (3477123940, gianpaolo.ronconi@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb angle (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06012032, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.