Musculoskeletal DiseasesDEMMIURISNCT04762927
Metric Properties of de Morton Mobility Index
An observational study of Musculoskeletal Diseases, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
Trial summary
Metric properties (convergent validity, predict validity, known-groups validity, responsiveness, floor and ceiling effects, minimal clinically important difference) of the de Morton Mobility Index (DEMMI) in patients with musculoskeletal impairments undergoing impatient rehabilitation will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Musculoskeletal Diseases
- How many people
- 60 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with musculoskeletal impairments with or without impairments of peripheral nerves
Who may be able to join
- admission to inpatient rehabilitation
- written informed consent
Who cannot join
- associated impairments of the central nervous system or other severe health conditions
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000
About this study
Official title: Metric Properties of de Morton Mobility Index in Rehabilitation Patients With Musculoskeletal Impairments
Metric properties (convergent validity, predict validity, known-groups validity, responsiveness, floor and ceiling effects, minimal clinically important difference) of the de Morton Mobility Index (DEMMI) in patients with musculoskeletal impairments undergoing impatient rehabilitation will be investigated.
Read the detailed description
Convergent validity of DEMMI will be assessed in terms of correlations with the other outcome measures. Known-groups validity will be demonstrated by differences in DEMMI scores between patients who were not able to walk and those who were able to walk with or without walking aid. Predictive validity of DEMMI at admission for functional independence at discharge from rehabilitation will be estimated. The minimal clinically important difference of DEMMI, responsiveness and floor or ceiling effects will also be estimated.
- Conditions
- Musculoskeletal Diseases
- Keywords
- DEMMI, outcome measurement, physiotherapy, clinimetric properties
- Medical subject headings
- Musculoskeletal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
de Morton Mobility Index - change
DEMMI is a unidimensional 15-item measure of mobility for adults
Measured: Approximately 30 days (difference between admission and discharge)
Secondary outcomes (4)
Ten-meter Walk Test
10mWT assesses comfortable walking speed over the distance of 10 meters
Measured: Approximately 30 days (difference between admission and discharge)
Six-minute Walk Test - change
6mWT assesses assess aerobic capacity and endurance
Measured: Approximately 30 days (difference between admission and discharge)
Functional Independence Measure - change
FIM is an 18-item two-dimensional instrument that explores physical and psychosocial functioning
Measured: Approximately 30 days (difference between admission and discharge)
EQ-5D-3L - change
EQ-5D-3L is a patient-reported instrument for measuring HRQOL
Measured: Approximately 30 days (difference between admission and discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleksander Zupanc, PT, MSc, Principal investigator, University Rehabilitation Institute, Republic of Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762927
- Sponsor's protocol ID
- URIS202101
- Acronym
- DEMMIURIS
- Status last verified
- Mar 2022
- First submitted
- 12 Feb 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metric Properties of de Morton Mobility Index in Rehabilitation Patients With Musculoskeletal Impairments
- ClinicalTrials.gov ID
- NCT04762927
- Acronym / sponsor ID
- DEMMIURIS / URIS202101
- Conditions
- Musculoskeletal Diseases
- Keywords
- DEMMI, outcome measurement, physiotherapy, clinimetric properties
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Feb 2021 (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.
Metric properties (convergent validity, predict validity, known-groups validity, responsiveness, floor and ceiling effects, minimal clinically important difference) of the de Morton Mobility Index (DEMMI) in patients with musculoskeletal impairments undergoing impatient rehabilitation will be investigated.
Detailed description
Convergent validity of DEMMI will be assessed in terms of correlations with the other outcome measures. Known-groups validity will be demonstrated by differences in DEMMI scores between patients who were not able to walk and those who were able to walk with or without walking aid. Predictive validity of DEMMI at admission for functional independence at discharge from rehabilitation will be estimated. The minimal clinically important difference of DEMMI, responsiveness and floor or ceiling effects will also be estimated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with musculoskeletal impairments with or without impairments of peripheral nerves
Key inclusion criteria (2 listed)
- admission to inpatient rehabilitation
- written informed consent
Key exclusion criteria (1 listed)
- associated impairments of the central nervous system or other severe health conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
de Morton Mobility Index - change
Time frame: Approximately 30 days (difference between admission and discharge)
DEMMI is a unidimensional 15-item measure of mobility for adults
4 secondary outcomes
Ten-meter Walk Test
Time frame: Approximately 30 days (difference between admission and discharge)
Six-minute Walk Test - change
Time frame: Approximately 30 days (difference between admission and discharge)
Functional Independence Measure - change
Time frame: Approximately 30 days (difference between admission and discharge)
EQ-5D-3L - change
Time frame: Approximately 30 days (difference between admission and discharge)
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 18 Mar 2022.
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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.
Aleksander Zupanc, PT, MSc principal investigator
University Rehabilitation Institute, Republic of Slovenia
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 Musculoskeletal Diseases, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
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 2 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 18 Mar 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 Slovenia. 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?
de Morton Mobility Index - change (time frame: Approximately 30 days (difference between admission and discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2022.