- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04762927
Metric Properties of de Morton Mobility Index (DEMMIURIS)
March 17, 2022 updated by: University Rehabilitation Institute, Republic of Slovenia
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ljubljana, Slovenia, 1000
- University Rehabilitation Institute, Republic of Slovenia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with musculoskeletal impairments with or without impairments of peripheral nerves
Description
Inclusion Criteria:
- admission to inpatient rehabilitation
- written informed consent
Exclusion Criteria:
- associated impairments of the central nervous system or other severe health conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Approximately 30 days (difference between admission and discharge)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ten-meter Walk Test
Time Frame: Approximately 30 days (difference between admission and discharge)
|
10mWT assesses comfortable walking speed over the distance of 10 meters
|
Approximately 30 days (difference between admission and discharge)
|
Six-minute Walk Test - change
Time Frame: Approximately 30 days (difference between admission and discharge)
|
6mWT assesses assess aerobic capacity and endurance
|
Approximately 30 days (difference between admission and discharge)
|
Functional Independence Measure - change
Time Frame: Approximately 30 days (difference between admission and discharge)
|
FIM is an 18-item two-dimensional instrument that explores physical and psychosocial functioning
|
Approximately 30 days (difference between admission and discharge)
|
EQ-5D-3L - change
Time Frame: Approximately 30 days (difference between admission and discharge)
|
EQ-5D-3L is a patient-reported instrument for measuring HRQOL
|
Approximately 30 days (difference between admission and discharge)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Aleksander Zupanc, PT, MSc, University Rehabilitation Institute, Republic of Slovenia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
February 12, 2021
First Submitted That Met QC Criteria
February 17, 2021
First Posted (Actual)
February 21, 2021
Study Record Updates
Last Update Posted (Actual)
March 18, 2022
Last Update Submitted That Met QC Criteria
March 17, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- URIS202101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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