NCT05806242

Brief Summary

This study is an observational study that aims to validate the Elderly Mobility Scale (EMS) in Italian (EMS-I) by comparison with the Barthel Index scale, already validated in Italian. Furthermore this study wants to evaluate the inter-rater reliability comparing the scores assigned to the same sample of patients by two independent evaluators. The study population includes 50 elderly in-patients eligible for physiotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

October 23, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

March 28, 2023

Last Update Submit

October 19, 2023

Conditions

Keywords

elderly subjectsrehabilitationElderly Mobility Scale

Outcome Measures

Primary Outcomes (1)

  • Italian Elderly Mobility Scale (EMS) in Italian (EMS-I) validity

    Elderly Mobility Scale (EMS) is a validated assessment tool test used by physiotherapists to assess the level of mobility in frail older adults. The total score ranges from 0 (totally dependent) to 20 (independent mobility). The Italian version (EMS-I) has required a standardized translation protocol, including forward and backward translation. EMS-I will be validated by comparison with the Barthel Index scale, already validated in Italian.

    baseline

Study Arms (1)

Validation

Elderly in-patients eligible for physiotherapy admitted to IRCCS-INRCA Hospital

Other: Italian Validation of the Italian Elderly Mobility Scale (EMS-I)

Interventions

Two physiotherapists independently evaluate the same enrolled patient with the Italian Elderly Mobility Scale (EMS-I) and Barthel Index

Validation

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly frail in-patients

You may qualify if:

  • Patients admitted to the IRCCS-INRCA Hospital
  • Request for physiotherapy evaluation
  • Sign of the informed consent

You may not qualify if:

  • Lack of Medical approval for sitting and standing position.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS INRCA Hospital

Ancona, 60127, Italy

Location

Related Publications (1)

  • Nicolai M, Casoni E, Bertino E, David L, Polverigiani C, Mallucci F, Fioretti P, Leonzi S, Bevilacqua R, Barbarossa F, Maranesi E, Baccini M, Barboni I, Riccardi GR. Evaluation of the Italian version of the elderly mobility scale in older hospitalized patients. Front Public Health. 2023 Nov 15;11:1274047. doi: 10.3389/fpubh.2023.1274047. eCollection 2023.

Study Design

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

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 10, 2023

Study Start

September 6, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

October 23, 2023

Record last verified: 2023-03

Locations