NCT04762927

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

February 12, 2021

Last Update Submit

March 17, 2022

Conditions

Musculoskeletal Diseases

Keywords

DEMMIoutcome measurementphysiotherapyclinimetric properties

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Ten-meter Walk Test

    Approximately 30 days (difference between admission and discharge)

  • Six-minute Walk Test - change

    Approximately 30 days (difference between admission and discharge)

  • Functional Independence Measure - change

    Approximately 30 days (difference between admission and discharge)

  • EQ-5D-3L - change

    Approximately 30 days (difference between admission and discharge)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with musculoskeletal impairments with or without impairments of peripheral nerves

You may qualify if:

  • admission to inpatient rehabilitation
  • written informed consent

You may not qualify if:

  • associated impairments of the central nervous system or other severe health conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Aleksander Zupanc, PT, MSc

    University Rehabilitation Institute, Republic of Slovenia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 21, 2021

Study Start

January 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 18, 2022

Record last verified: 2022-03

Locations

SL(1)