- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06800924
Posture and Spinal Mobility in Anorexia Nervosa (SPINALAN)
Analysis of Posture and Spinal Mobility in Women Suffering From Anorexia Nervosa
The primary objective of the study is to compare the results of the postural and mobility analysis obtained with the use of the Idiag M360 instrument in adult women with anorexia nervosa and in a control group represented by age-matched normal-weight women.
Secondary objectives will be to correlate the results obtained from previous postural analyses with anthropometric parameters, the duration and onset of the disease, and the presence/date of onset of secondary amenorrhea.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Verbania
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Oggebbio, Verbania, Italy, 28824
- Istituto Auxologico Italiano IRCCS, Site Piancavallo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The subjects admitted to the study will be recruited at the beginning of hospitalization in the Division of Eating and Nutrition Disorders (END), Istituto Auxologico Italiano, IRCCS, Piancavallo (VB), Italy. Thirty women suffering from anorexia nervosa clinically diagnosed based on the DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders 5; American Psychiatric Association, 2013), aged ≥ 18 years, will be studied.
As a control group, 30 normal-weight adult women (age: ≥ 18 years; BMI: 18.5-24.9 kg/m2) will be recruited from the medical/nursing and research staff.
Description
Anorexia Nervosa:
Inclusion Criteria:
- Female sex
- Age 18 years and older
- Anorexia nervosa clinically diagnosed based on the DSM-5 criteria
- Hospitalized in the Division of Eating and Nutrition Disorders (END), Istituto Auxologico Italiano, IRCCS, Piancavallo (VB), Italy
Exclusion Criteria:
- Absence of signed informed consent
- Musculoskeletal or neurological conditions (leg length discrepancy, spinal deformities, and physical disabilities caused by surgery)
- Treatment with anti-inflammatory drugs
Normal Weight:
Inclusion Criteria:
- Female sex
- Age 18 years and older
- BMI: 18.5-24.9 kg/m2
- Recruited from the medical/nursing and research staff
Exclusion Criteria:
- Absence of signed informed consent
- Musculoskeletal or neurological conditions (leg length discrepancy, spinal deformities, and physical disabilities caused by surgery)
- Treatment with anti-inflammatory drugs
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Anorexia Nervosa
Women suffering from anorexia nervosa clinically diagnosed based on the DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders 5; American Psychiatric Association, 2013), aged ≥ 18 years
|
Postural and mobility parameters were obtained with the use of the Idiag M360 scan tool (Idiag, Fehraltorf, Switzerland)
|
|
Normal weight
Normal-weight adult women (age: ≥ 18 years; BMI: 18.5-24.9
kg/m2), recruited from the medical/nursing and research staff.
|
Postural and mobility parameters were obtained with the use of the Idiag M360 scan tool (Idiag, Fehraltorf, Switzerland)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lateral flexion
Time Frame: Baseline
|
Idiag M360 scan tool (Idiag, Fehraltorf, Switzerland); flexion expressed in degrees
|
Baseline
|
|
Lumbar flexion
Time Frame: Baseline
|
IIdiag M360 scan tool (Idiag, Fehraltorf, Switzerland); flexion expressed in degrees
|
Baseline
|
|
Lumbar extension
Time Frame: Baseline
|
IIdiag M360 scan tool (Idiag, Fehraltorf, Switzerland); extension expressed in degrees
|
Baseline
|
|
Thoracic extension
Time Frame: Baseline
|
IIdiag M360 scan tool (Idiag, Fehraltorf, Switzerland); extension expressed in degrees
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01C416
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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