NCT03233789

Brief Summary

The aim of this mixed-methods-study is to develop and validate an algorithm to transform FIM (Functional Independence Measure) and EBI (Extended Barthel Index) into an ADL score (Activities of Daily Life) that can be used to compare outcome quality of rehabilitation clinics. The following steps are performed:

  1. 1.Development of an ADL-algorithms by experts
  2. 2.Validation of the ADL-algorithms in a quantitative approach
  3. 3.Finalization of the ADL-algorithms by experts based on study results

Trial Health

100
On Track

Trial Health Score

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

Enrollment
265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

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

November 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

July 25, 2017

Last Update Submit

January 30, 2019

Conditions

Neurologic DisorderICFMedical RehabilitationAssessmentFunctional IndependenceObservational Study

Outcome Measures

Primary Outcomes (1)

  • Agreement FIM-based ADL-score vs. EBI-based ADL-score

    Agreement according to Cohens kappa (FIM-based ADL-score vs. EBI-based ADL-score)

    within 3 days of admission to rehabilitation clinic

Secondary Outcomes (2)

  • Correlation FIM-based ADL-score vs. EBI-based ADL-score

    within 3 days of admission to rehabilitation clinic

  • Difference in FIM-based ADL-score vs. EBI-based ADL-score

    within 3 days of admission to rehabilitation clinic

Interventions

neurologic rehabilitationBEHAVIORAL

in-patient rehabilitation of neurologic disorders

Eligibility Criteria

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

Patients with neurologic disorders in in-patient rehabilitation

You may qualify if:

  • Admission to in-patient neurologic rehabilitation clinic

You may not qualify if:

  • No sufficient language skills (German, French or Italian)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nervous System Diseases

Interventions

Neurological Rehabilitation

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Karla Spyra, Prof. Dr.

    Charite University, Berlin, Germany

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

July 25, 2017

First Posted

July 31, 2017

Study Start

November 1, 2015

Primary Completion

February 24, 2017

Study Completion

December 31, 2017

Last Updated

January 31, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share