Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000649415
Ethics application status
Approved
Date submitted
18/12/2007
Date registered
20/12/2007
Date last updated
20/12/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Dysfunctional Patellar Misalignment at the passage from the supine to the sitting position and vice versa in patients with a negative anamnesis for muscular or bone-relevant trauma.
Scientific title
Evaluation of Dysfunctional Patellar Misalignment at the passage from the supine to the sitting position and vice versa in patients with a negative anamnesis for muscular or bone-relevant trauma.
Universal Trial Number (UTN)
Trial acronym
PFD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysfunctional patellar misalignment 2642 0
Condition category
Condition code
Musculoskeletal 2757 2757 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Slight somatic differences, when not due to specific causes, prove the existence of Fluctuating Asymmetry (FA). FAs are defined as a casual loss of perfect symmetry, highlighted at level of symmetrical body segments and caused by environmental stressors. They are inversely related with the general psycho-physical condition of the subject. In this study that has involved in eight years 3700 subjects, we have highlighted and described the presence of asymmetry both in tonic and phasic activation of symmetrical muscular groups. We named this asymmetrical activation as Functional Dysmetria (FD). We might assume that FD is determined by a neuropsychomotor attitude deriving from the adaptation at environmental stress, as observed for FAs. We could also suppose that the asymmetrical tonic and phasic activation of symmetrical muscular groups may determine those alterations of structural charge, this causing those modifications in skeleton morphology typical of FAs. The observation has been carried out with subject in supine position, in sitting position, during the passage from supine to sitting position and vice versa. So as to quantify misalignment and then FD, we employed a not invasive calibre that we have specifically devised, with 1-mm-resolution. The measurements, were taken with the subject in supine position, in sitting position. After each check the subject was asked to descend the bed and walk a dozen steps; afterwards they laid down again on the bed for a new survey. All this was repeated three consecutive times for each subject.
Intervention code [1] 2378 0
Diagnosis / Prognosis
Comparator / control treatment
No treatment. Between each consecutive observation and measurement we took five minutes and we took fifteen minutes after the first and second session.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3644 0
The observation of the presence of asymmetrical both in tonic and phasic activation of symmetrical muscular groups and patellar misalignment at the passage from the supine to the sitting position and vice versa and the quantification of this misalignment with a non invasive calibre that we have specifically devised, with 1-mm-resolution.
Timepoint [1] 3644 0
The observational and measurement trial consisted of two following sessions. In every session we have take three observations and measurements: immediately, after five minutes the second and after other five minutes the third session. The second session like the first one was carried out after fifteen minutes.
Secondary outcome [1] 6119 0
Detect the presence of patellar misalignment at the passage from the supine to the sitting position and vice versa and the quantification of this misalignment with a non invasive calibre that we have specifically devised, with 1-mm-resolution.
Timepoint [1] 6119 0
The observational and measurement trial consisted of two following sessions. In every session we have take three observations and measurements: immediately, after five minutes the second and after other five minutes the third session. The second session like the first one was carried out after fifteen minutes.

Eligibility
Key inclusion criteria
Healthy subjects, with a negative anamnesis for muscular or bone-relevant trauma and patologies during the last 2 years
Minimum age
2 Years
Maximum age
97 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects, with positive anamnesis for muscular or bone-relevant trauma in the last 2 years. Congenital malformation and other musculoskeletal or neurologically-known pathologies

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/1997
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3700
Accrual to date
Final
Recruitment outside Australia
Country [1] 714 0
Italy
State/province [1] 714 0

Funding & Sponsors
Funding source category [1] 2896 0
Charities/Societies/Foundations
Name [1] 2896 0
Istituto Rinaldi Fontani
Country [1] 2896 0
Italy
Primary sponsor type
Charities/Societies/Foundations
Name
Istituto Rinaldi Fontani
Address
Via Nazionale 23 50123 Firenze
Country
Italy
Secondary sponsor category [1] 2617 0
Charities/Societies/Foundations
Name [1] 2617 0
Societa di Ottimizzazione Neuro Psico Fisica e CRM Terapia
Address [1] 2617 0
Via Nazionale 23 50123 Firenze
Country [1] 2617 0
Italy

Ethics approval
Ethics application status
Approved

Summary
Brief summary
It is generally agreed that, in absence of orthopaedic pathologies, a misalignment of certain body segments may be highlighted in a certain group of examined subjects. These misalignments are especially evident at level of pelvis and Lower Limbs (LLs). This observation lead us to believe that this was an ordinary phenomenon of postural neuropsychomotor attitude, consequence of a dysfunctional adaptation to environmental stress, exactly as for Fluctuating Asymmetry. Through the observation of a wide sample of 3700 subjects, we could detect the presence of an asymmetry in tonic and phasic activation of symmetrical muscular groups in LLs. This activation will show through a misalignment of upper and lower right and left patellar margins, misalignment which will invert by moving from supine to sitting position while the subject is lying on the visiting bed . We named this phenomenon as Functional Dysmetria (FD), which we believe to be upheld by postural neuropsychomotor mechanisms, as expression of a dysfunctional adaptive attitude in response to the interaction between subject and environment. FD may be compared to an actual difference in length of LLs, but not necessarily is to be associated with a real heterometry, from which it must therefore be kept aside. We chose the definition of “Dysmetria” to underline both the dysfunctional (from the Greek d?? = difficulty to perform, and µ?t??? = measurement) and functional components, as the phenomenon is apparently not the consequence of organic injuries. In conclusion, the analysis of the results shows that every examined subject had both the misalignment of the considered reperes and a FD of LLs, highlighted at the passage from the supine to the sitting position and vice versa. The average value of misalignment is 6.21 mm (StDev = 0.38). The values of misalignment vary among subjects and are not related to age or sex. Furthermore, the examined values do not modify upon repositioning of the subject and are stable in time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28249 0
Address 28249 0
Country 28249 0
Phone 28249 0
Fax 28249 0
Email 28249 0
Contact person for public queries
Name 11406 0
Vania Fontani M.D.
Address 11406 0
Via Nazionale 23 50123 Firenze
Country 11406 0
Italy
Phone 11406 0
+39 055 290307
Fax 11406 0
Email 11406 0
[email protected]
Contact person for scientific queries
Name 2334 0
Salvatore Rinaldi M.D.
Address 2334 0
Via Nazionale 23 50123 Firenze
Country 2334 0
Italy
Phone 2334 0
+39 055 290307
Fax 2334 0
Email 2334 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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