Critical CareNCT05196997
The De-Morton Mobility Index Turkish Version in Intensive Care Patients
An observational study of Critical Care and Function, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
De Morton Mobility Index is recommended for the evaluation of mobility in the evidence-based guidelines, in patients in intensive care units. The aim of our study is to examine the validity and reliability of the Turkish version of the De Morton Mobility Index in patients hospitalized in the respiratory intensive care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Function, Mobility
- What is being tested?
- Mobility and Functional Assessments
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 20 Feb 2019
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients aged above 18 years who stayed in the intensive care unit for at least 24 hours and were discharged from the ICU were included in our study.
Who may be able to join
- staying in intensive care unit for at least 24 hours
- able to cooperate
- being clinically stable for mobility assessment
Who cannot join
- the presence of neurological disease
- the presence of orthopedic problems such as fractures
- the presence of metastases
- the presence of cardiorespiratory instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Construct Validity and Test-Retest Reliability of The De-Morton Mobility Index Turkish Version in Intensive Care Patients
De Morton Mobility Index is recommended for the evaluation of mobility in the evidence-based guidelines, in patients in intensive care units. The aim of our study is to examine the validity and reliability of the Turkish version of the De Morton Mobility Index in patients hospitalized in the respiratory intensive care unit.
Read the detailed description
De Morton Mobility Index is recommended for the evaluation of mobility in the evidence-based guidelines, in patients in intensive care units. The aim of our study is to examine the validity and reliability of the Turkish version of the De Morton Mobility Index in patients hospitalized in the respiratory intensive care unit.
Patients aged 18 years and over who were discharged from the ICU were included in our study.
We used De-Morton Mobility Index, Bartel Index, Katz Activities of Daily Living Rating Scale and MRC Muscle Strength Test for convergent validity. De-Morton Mobility assessment for test-retest reliability was performed again on the 1st day of the patient's service.
- Conditions
- Critical Care, Function, Mobility
- Being tested
- Mobility and Functional Assessments
- Keywords
- critical care, function, mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobility and Functional AssessmentsOther
The first evaluation was made on the day the patient was discharged from the intensive care unit. DEMMI, Bartel Index, Katz Activities of Daily Living Rating Scale and MRC Muscle Strength Test were performed to the patient, respectively.
De-Morton Mobility assessment for test-retest reliability was performed again on the 1st day of the patient's service.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility Assessment
De Morton Mobility Index: It consists of a total of 15 mobility items. The total score ranges from 0-100, with 0 indicating poor mobility and 100 indicating high mobility
Measured: 15 minutes
Secondary outcomes (3)
Functional independence measurement
The Barthel index: It includes 10 items: nutrition, bathroom, personal care, dressing, toilet use, mobility on flat surfaces (immobile, wheelchair use, walking with assistance or independently), transfer (transfer from wheelchair to bed and vice versa), climbing stairs, bowel and bladder continence. It is scored between 0-100. 0; fully independent, 100; means fully independent.
Measured: 5 minutes
Assessment of daily living activities
Katz Index: The index includes basic parameters of daily living activities such as bathing, dressing, toilet, transfer, urine and stool control, nutrition. The scoring of the index varies in the range of 0-6. Higher scores indicate higher independence
Measured: 5 minutes
Muscle Strength
Medical Research Council scale: It includes muscle strength test of six muscle groups. Scoring ranges from 0 to 5 in each muscle group. The maximum score is 60, and a score below 48 indicates significant muscle weakness
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Apr 2018
- Primary completion20 Feb 2019
- Study completion20 Feb 2019
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 Critical CareStudies of the same condition, open and under way.
- More trials run by Izmir Katip Celebi UniversityThe sponsor's other registered studies.
- 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
- 150 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Naz, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196997
- Sponsor's protocol ID
- DM111
- Status last verified
- Jan 2022
- First submitted
- 9 Jan 2022
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naz I, Turgut B, Ediboglu O, Kirakli C. Clinimetric properties of the Turkish version of the De-Morton Mobility Index (DEMMI) in intensive care unit survivors - a cross-sectional observational study. Disabil Rehabil. 2023 Nov;45(22):3730-3736. doi: 10.1080/09638288.2022.2134935. Epub 2022 Oct 20.
PubMed 36263947
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construct Validity and Test-Retest Reliability of The De-Morton Mobility Index Turkish Version in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT05196997
- Acronym / sponsor ID
- DM111
- Conditions
- Critical Care, Function, Mobility
- Keywords
- critical care, function, mobility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 19 Jan 2022 (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.
De Morton Mobility Index is recommended for the evaluation of mobility in the evidence-based guidelines, in patients in intensive care units. The aim of our study is to examine the validity and reliability of the Turkish version of the De Morton Mobility Index in patients hospitalized in the respiratory intensive care unit.
Detailed description
De Morton Mobility Index is recommended for the evaluation of mobility in the evidence-based guidelines, in patients in intensive care units. The aim of our study is to examine the validity and reliability of the Turkish version of the De Morton Mobility Index in patients hospitalized in the respiratory intensive care unit.
Patients aged 18 years and over who were discharged from the ICU were included in our study.
We used De-Morton Mobility Index, Bartel Index, Katz Activities of Daily Living Rating Scale and MRC Muscle Strength Test for convergent validity. De-Morton Mobility assessment for test-retest reliability was performed again on the 1st day of the patient's service.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged above 18 years who stayed in the intensive care unit for at least 24 hours and were discharged from the ICU were included in our study.
Key inclusion criteria (3 listed)
- staying in intensive care unit for at least 24 hours
- able to cooperate
- being clinically stable for mobility assessment
Key exclusion criteria (4 listed)
- the presence of neurological disease
- the presence of orthopedic problems such as fractures
- the presence of metastases
- the presence of cardiorespiratory instability
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 |
|---|---|---|
| Mobility and Functional AssessmentsThe first evaluation was made on the day the patient was discharged from the intensive care unit. DEMMI, Bartel Index, Katz Activities of Daily Living Rating Scale and MRC Muscle Strength Test were performed to the patient, respectively. De-Morton Mobility assessment for test-retest reliability was performed again on the 1st day of the patient's service. | Other | – |
Primary outcome
Mobility Assessment
Time frame: 15 minutes
De Morton Mobility Index: It consists of a total of 15 mobility items. The total score ranges from 0-100, with 0 indicating poor mobility and 100 indicating high mobility
3 secondary outcomes
Functional independence measurement
Time frame: 5 minutes
Assessment of daily living activities
Time frame: 5 minutes
Muscle Strength
Time frame: 10 minutes
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 19 Jan 2022.
- Derived from this study: PubMed 36263947Naz I, Turgut B, Ediboglu O, Kirakli C. Clinimetric properties of the Turkish version of the De-Morton Mobility Index (DEMMI) in intensive care unit survivors - a cross-sectional observational study. Disabil Rehabil. 2023 Nov;45(22):3730-3736. doi: 10.1080/09638288.2022.2134935. Epub 2022 Oct 20.
- Individual participant dataSharing planned: No
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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 Critical Care and Function, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 4 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 19 Jan 2022. 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 Turkey (Türkiye). 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?
Mobility Assessment (time frame: 15 minutes). 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 NCT05196997, 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 19 Jan 2022.