Application of BHOHB SPINAL-METER and CervicalMeter for Posture Assessment

NCT06012032 | Unknown

• 1 other identifier: 4381
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Osteoporosis; Scoliosis; Postural; Defect

Outcome Measures

Primary Outcomes (1)

• Cobb angle

  radiographic angle measuring the degree of scoliosis in the frontal plane

  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

  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

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Psychiatric pathologies,
• Cognitive impairment (MMSE\<23),
• Inability to stand and walk.
• Failure to sign the informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Gianpaolo Ronconi

Roma, 00168, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 3944402 BACKGROUND

• Berg 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.

  PMID: 1468055 BACKGROUND

• EuroQol 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.

  PMID: 10109801 BACKGROUND

• Cohen 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.

  PMID: 29026895 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Osteoporosis; Scoliosis

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Curvatures; Spinal Diseases

Study Officials

• gianpaolo ronconi

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronconi

CONTACT

3477123940; gianpaolo.ronconi@unicatt.it

gianpaolo ronconi

CONTACT

3477123940; gianpaolo.ronconi@unicatt.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: August 25, 2023
• Study Start: February 17, 2022
• Primary Completion: February 17, 2024
• Study Completion: February 17, 2024
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

IT (1)