Development and Validation of an ADL-score Based on FIM a... | NCT03233789

Studies
Development and Validation of an ADL-score Based on FIM and EBI

NCT03233789

Sponsor

Martin Brünger

Status

Completed

Last Update Posted

Jan 31, 2019Actual

Enrollment

265Actual

Phase

Not provided

Conditions

Neurologic Disorder
ICF
Medical Rehabilitation
Assessment
Functional Independence
Observational Study

Interventions

neurologic rehabilitation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1223-6650	Other Identifier	World Health Organization

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2015Actual

Primary Completion Date

Feb 24, 2017Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

Jul 25, 2017

First Submission Date that Met QC Criteria

Jul 26, 2017

First Posted Date

Jul 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2019

Last Update Posted Date

Jan 31, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Martin Brünger, Investigator, Charite University, Berlin, GermanySponsor-Investigator

Lead Sponsor

Martin BrüngerOTHER

Collaborators

Name	Class
Association nationale pour le développement de la qualité dans les hôpitaux et les cliniques (ANQ), Bern, Switzerland	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

265Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
neurologic rehabilitation	Behavioral	in-patient rehabilitation of neurologic disorders

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Correlation FIM-based ADL-score vs. EBI-based ADL-score	Spearman's 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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Admission to in-patient neurologic rehabilitation clinic

Exclusion Criteria:

No sufficient language skills (German, French or Italian)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with neurologic disorders in in-patient rehabilitation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karla Spyra, Prof. Dr.	Charite University, Berlin, Germany	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009422	Nervous System Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000066530	Neurological Rehabilitation

Ancestor Terms

ID	Term
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided