Physical Functional PerformanceEMS-INCT05806242
EMS-I: Validation of the Italian Version of the Elderly Mobility Scale
An observational study of Physical Functional Performance, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Physical Functional Performance
- What is being tested?
- Italian Validation of the Italian Elderly Mobility Scale (EMS-I)
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 6 Sep 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
Study population: Elderly frail in-patients
Who may be able to join
- Patients admitted to the IRCCS-INRCA Hospital
- Request for physiotherapy evaluation
- Sign of the informed consent
Who cannot join
- Lack of Medical approval for sitting and standing position.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
The Elderly Mobility Scale (EMS) is considered a suitable tool to assess basic motor function in hospitalized geriatric patients. It has shown good psychometric characteristics.
The study process requires a standardized translation protocol, including forward and backward translation. The protocol provides enrollment of 50 geriatric in-patients eligible for physiotherapy admitted to IRCCS-INRCA Hospital. Two physiotherapists independently evaluate the same enrolled patient with Italian EMS (EMS-I) and Barthel Index.
- Conditions
- Physical Functional Performance
- Being tested
- Italian Validation of the Italian Elderly Mobility Scale (EMS-I)
- Keywords
- elderly subjects, rehabilitation, Elderly Mobility Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Italian Validation of the Italian Elderly Mobility Scale (EMS-I)Other
Two physiotherapists independently evaluate the same enrolled patient with the Italian Elderly Mobility Scale (EMS-I) and Barthel Index
| Study group | Role | What they receive |
|---|---|---|
| Validation | Elderly in-patients eligible for physiotherapy admitted to IRCCS-INRCA Hospital Receives: Other: Italian Validation of the Italian Elderly Mobility Scale (EMS-I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start6 Sep 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical Functional PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806242
- Sponsor's protocol ID
- INRCA_003_2023
- Acronym
- EMS-I
- Status last verified
- Mar 2023
- First submitted
- 28 Mar 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38035291
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMS-I: Validation of the Italian Version of the Elderly Mobility Scale
- ClinicalTrials.gov ID
- NCT05806242
- Acronym / sponsor ID
- EMS-I / INRCA_003_2023
- Conditions
- Physical Functional Performance
- Keywords
- elderly subjects, rehabilitation, Elderly Mobility Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The Elderly Mobility Scale (EMS) is considered a suitable tool to assess basic motor function in hospitalized geriatric patients. It has shown good psychometric characteristics.
The study process requires a standardized translation protocol, including forward and backward translation. The protocol provides enrollment of 50 geriatric in-patients eligible for physiotherapy admitted to IRCCS-INRCA Hospital. Two physiotherapists independently evaluate the same enrolled patient with Italian EMS (EMS-I) and Barthel Index.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Validation | – | Other: Italian Validation of the Italian Elderly Mobility Scale (EMS-I)Elderly in-patients eligible for physiotherapy admitted to IRCCS-INRCA Hospital |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Elderly frail in-patients
Key inclusion criteria (3 listed)
- Patients admitted to the IRCCS-INRCA Hospital
- Request for physiotherapy evaluation
- Sign of the informed consent
Key exclusion criteria (1 listed)
- Lack of Medical approval for sitting and standing position.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Italian Validation of the Italian Elderly Mobility Scale (EMS-I)Two physiotherapists independently evaluate the same enrolled patient with the Italian Elderly Mobility Scale (EMS-I) and Barthel Index | Other | Validation |
Primary outcome
Italian Elderly Mobility Scale (EMS) in Italian (EMS-I) validity
Time frame: baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 38035291Nicolai 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.
Related trials for Physical Functional Performance
Not yet recruiting
Assessment of Binocular Vision Function With Neos™ (ROCKET)
Binocular Vision Dysfunction
Not yet recruiting
Effects of Virtual Reality Exergaming on Reaction Time, Physical Performance, and Muscle Activity in Children
Neuromuscular Performance, Reaction Time
Not yet recruiting
EFFECT OF ADDING BLOOD FLOW RESTRICTION TRAINING TO CLOSED CHAIN EXERCISE IN KNEE OSTEOARTHRITIS
Knee Osteoarthritis
RecruitingObservational study
Post-Stroke Apraxia, Motor Function, Balance, and Gait
Stroke, Ideomotor Apraxia
Not yet recruiting
Acute Effects of Breathing Resistance During Exercise in Football Players
Respiratory Muscle Function and Football Performance
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Functional Performance, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Italian Elderly Mobility Scale (EMS) in Italian (EMS-I) validity (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05806242, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.