Neurologic DisorderEVANCT03233789
Development and Validation of an ADL-score Based on FIM and EBI
An observational study of Neurologic Disorder and ICF, run by Martin Brünger.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurologic Disorder, ICF, Medical Rehabilitation
- What is being tested?
- neurologic rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 265 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2015to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with neurologic disorders in in-patient rehabilitation
Who may be able to join
- Admission to in-patient neurologic rehabilitation clinic
Who cannot join
- No sufficient language skills (German, French or Italian)
About this study
Official title: Entwicklung Und Validierung Eines ADL-Scores (Activities of Daily Life) Auf Basis Von FIM (Functional Independence Measure) Und EBI (Erweiterter Barthel-Index)
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
- Conditions
- Neurologic Disorder, ICF, Medical Rehabilitation, Assessment, Functional Independence, Observational Study
- Being tested
- neurologic rehabilitation
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurologic rehabilitationBehavioural
in-patient rehabilitation of neurologic disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement FIM-based ADL-score vs. EBI-based ADL-score
Agreement according to Cohens kappa (FIM-based ADL-score vs. EBI-based ADL-score)
Measured: within 3 days of admission to rehabilitation clinic
Secondary outcomes (2)
Correlation FIM-based ADL-score vs. EBI-based ADL-score
Spearman's correlation (FIM-based ADL-score vs. EBI-based ADL-score)
Measured: within 3 days of admission to rehabilitation clinic
Difference in FIM-based ADL-score vs. EBI-based ADL-score
Delta in points FIM-based ADL-score vs. EBI-based ADL-score
Measured: within 3 days of admission to rehabilitation clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start1 Nov 2015
- Primary completion24 Feb 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin Brünger
- Sponsor type
- University, hospital or other
- Collaborators
- Association nationale pour le développement de la qualité dans les hôpitaux et les cliniques (ANQ), Bern, Switzerland
- Responsible party
- Sponsor-investigator, Martin Brünger, Charite University, Berlin, Germany
- Investigators
- Karla Spyra, Prof. Dr., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233789
- Sponsor's protocol ID
- ANQ-FIM-EBI
- Other IDs
- U1111-1223-6650
- Acronym
- EVA
- Status last verified
- Jan 2019
- First submitted
- 25 Jul 2017
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entwicklung Und Validierung Eines ADL-Scores (Activities of Daily Life) Auf Basis Von FIM (Functional Independence Measure) Und EBI (Erweiterter Barthel-Index)
- ClinicalTrials.gov ID
- NCT03233789
- Acronym / sponsor ID
- EVA / ANQ-FIM-EBI
- Conditions
- Neurologic Disorder, ICF, Medical Rehabilitation, Assessment, Functional Independence, Observational Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Martin BrüngerUniversity, hospital or other
- Collaborators
- Association nationale pour le développement de la qualité dans les hôpitaux et les cliniques (ANQ), Bern, Switzerland
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 24 Feb 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 31 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with neurologic disorders in in-patient rehabilitation
Key inclusion criteria (1 listed)
- Admission to in-patient neurologic rehabilitation clinic
Key exclusion criteria (1 listed)
- No sufficient language skills (German, French or Italian)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurologic rehabilitationin-patient rehabilitation of neurologic disorders | Behavioural | – |
Primary outcome
Agreement FIM-based ADL-score vs. EBI-based ADL-score
Time frame: within 3 days of admission to rehabilitation clinic
Agreement according to Cohens kappa (FIM-based ADL-score vs. EBI-based ADL-score)
2 secondary outcomes
Correlation FIM-based ADL-score vs. EBI-based ADL-score
Time frame: within 3 days of admission to rehabilitation clinic
Difference in FIM-based ADL-score vs. EBI-based ADL-score
Time frame: within 3 days of admission to rehabilitation clinic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karla Spyra, Prof. Dr. study director
Charite University, Berlin, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Neurologic Disorder and ICF, run by Martin Brünger.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement FIM-based ADL-score vs. EBI-based ADL-score (time frame: within 3 days of admission to rehabilitation clinic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.