Metric Properties of de Morton Mobility Index (DEMMIURIS)

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

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

      • Ljubljana, Slovenia, 1000
        • University Rehabilitation Institute, Republic of Slovenia

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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