NCT06800924

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Jun 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Jun 2024Jun 2026

Study Start

First participant enrolled

June 6, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

January 24, 2025

Last Update Submit

March 25, 2026

Conditions

Anorexia Nervosa

Keywords

Anorexia nervosaSpinal mobilityPosture

Outcome Measures

Primary Outcomes (4)

  • Lateral flexion

    Idiag M360 scan tool (Idiag, Fehraltorf, Switzerland); flexion expressed in degrees

    Baseline

  • Lumbar flexion

    IIdiag M360 scan tool (Idiag, Fehraltorf, Switzerland); flexion expressed in degrees

    Baseline

  • Lumbar extension

    IIdiag M360 scan tool (Idiag, Fehraltorf, Switzerland); extension expressed in degrees

    Baseline

  • Thoracic extension

    IIdiag M360 scan tool (Idiag, Fehraltorf, Switzerland); extension expressed in degrees

    Baseline

Study Arms (2)

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

Other: Postural and mobility analysis

Normal weight

Normal-weight adult women (age: ≥ 18 years; BMI: 18.5-24.9 kg/m2), recruited from the medical/nursing and research staff.

Other: Postural and mobility analysis

Interventions

Postural and mobility analysisOTHER

Postural and mobility parameters were obtained with the use of the Idiag M360 scan tool (Idiag, Fehraltorf, Switzerland)

Anorexia NervosaNormal weight

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • Female sex
  • Age 18 years and older
  • BMI: 18.5-24.9 kg/m2
  • Recruited from the medical/nursing and research staff
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2025

First Posted

January 30, 2025

Study Start

June 6, 2024

Primary Completion

October 16, 2024

Study Completion (Estimated)

June 30, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

IT(1)