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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04762927
Other study ID # URIS202101
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2021

Study information

Verified date March 2022
Source University Rehabilitation Institute, Republic of Slovenia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - admission to inpatient rehabilitation - written informed consent Exclusion Criteria: - associated impairments of the central nervous system or other severe health conditions

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Slovenia University Rehabilitation Institute, Republic of Slovenia Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
University Rehabilitation Institute, Republic of Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Primary de Morton Mobility Index - change DEMMI is a unidimensional 15-item measure of mobility for adults Approximately 30 days (difference between admission and discharge)
Secondary Ten-meter Walk Test 10mWT assesses comfortable walking speed over the distance of 10 meters Approximately 30 days (difference between admission and discharge)
Secondary Six-minute Walk Test - change 6mWT assesses assess aerobic capacity and endurance Approximately 30 days (difference between admission and discharge)
Secondary Functional Independence Measure - change FIM is an 18-item two-dimensional instrument that explores physical and psychosocial functioning Approximately 30 days (difference between admission and discharge)
Secondary EQ-5D-3L - change EQ-5D-3L is a patient-reported instrument for measuring HRQOL Approximately 30 days (difference between admission and discharge)
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