Determinants of Balance Recovery After Stroke - Retrospective Study (DOBRAS-R)

November 7, 2019 updated by: University Hospital, Grenoble

Determinants of Balance Recovery After Stroke

Retrospective cohort study of consecutive patients investigated in a neurorehabilitation ward after a first hemispheric stroke. Postural and gait disorders in relation to referential of verticality have been analyzed in routine care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

300 consecutive patients, admitted in our department for neurorehabilitation after a first hemispherical stroke, have been enrolled retrospectively. During their hospitalisation, all patients have been routinely evaluated with clinical scales, evaluating motor and cognitive deficits. Postural and visual vertical (VV) assessments have been performed 1 to 4 times during in-patient-stay.

The objective was to analyse the determinants of balance recovery after stroke, in particular the impact of wrong referential of verticality.

Data collection was performed by means of medical records. Observation period covered from january 2012 to february 2018.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

consecutive patients admitted in neurorehabilitation ward after first hemispheric stroke

Description

Inclusion Criteria:

first hemispheric stroke patient non-opposed to inclusion

Exclusion Criteria:

history of neurological disorders interfering with balance history of vestibularly disorders interfering with balance unstable medical conditions history of cognitive disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Posture
Time Frame: admission and monthly, up to 3 months
Change from Baseline Score of Postural Assessment Scale for Stroke (PASS) at discharge
admission and monthly, up to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: admission and monthly, up to 3 months
Assessment of Balance and Posture with SCP (Scale for Contraversive Pushing)
admission and monthly, up to 3 months
Gait
Time Frame: admission and monthly, up to 3 months
Assessment of Gait with Lindmark test
admission and monthly, up to 3 months
Postural disorders
Time Frame: admission and monthly, up to 3 months
Assessment of Postural control with CDP (Computerized posturography)
admission and monthly, up to 3 months
Visual vertical perception
Time Frame: admission and monthly, up to 3 months
Assessment of the visual vertical (vv). Subject indicates which direction a visual line displayed on a computer screen (in darkness) is perceived as vertical in the roll plane.
admission and monthly, up to 3 months
Postural vertical perception
Time Frame: admission and monthly, up to 3 months
Assessment of the postural vertical (pv). Subject is seated in a specific device (CE-marked) in darkness, and indicates which direction of her/his whole body is perceived as vertical in the roll plane.
admission and monthly, up to 3 months
Walking distance
Time Frame: admission and monthly, up to 3 months
Assessment of walking distance with the 6-minute-walking-test (6-MWT)
admission and monthly, up to 3 months
Gait velocity
Time Frame: admission and monthly, up to 3 months
Assessment of gait velocity at self-prefered-velocity on 10 meters
admission and monthly, up to 3 months
Pressure sensitivity (Hand and foot)
Time Frame: admission and monthly, up to 3 months
Assessment of hypoesthesia with Semmes-Weinstein monofilaments test
admission and monthly, up to 3 months
Spasticity
Time Frame: admission and monthly, up to 3 months
Assessment of Spasticity with Ashworth Scale
admission and monthly, up to 3 months
Laterality
Time Frame: admission and monthly, up to 3 months
Assessment of Laterality with Edinburgh Handedness Inventory
admission and monthly, up to 3 months
Disability
Time Frame: admission and monthly, up to 3 months
Assessment of Autonomy with FIM (Functional Independence Measure)
admission and monthly, up to 3 months
Neuropsychological Assessment 1
Time Frame: admission and monthly, up to 3 months
Assessment of Hemispatial Neglect with the Catherine Bergego Scale (CBS)
admission and monthly, up to 3 months
Neuropsychological Assessment 2
Time Frame: admission and monthly, up to 3 months
Assessment of Hemispatial Neglect with the fluff Test
admission and monthly, up to 3 months
Neuropsychological Assessment 3
Time Frame: admission and monthly, up to 3 months
Assessment of Hemispatial Neglect using 'thumb localizing test' (TLT)
admission and monthly, up to 3 months
Neuropsychological Assessment 4
Time Frame: admission and monthly, up to 3 months
Assessment of Hemispatial Neglect with the 'Comb and Razor Test'
admission and monthly, up to 3 months
Neuropsychological Assessment 5
Time Frame: admission and monthly, up to 3 months
Assessment of Hemispatial Neglect with the BEN ( Battery of tests for the quantitative assessment of unilateral neglect)
admission and monthly, up to 3 months
Neuropsychological Assessment 6
Time Frame: admission and monthly, up to 3 months
Assessment of Apraxia with ATS (Apraxia Screen of TULIA)
admission and monthly, up to 3 months
Neuropsychological Assessment 7
Time Frame: admission and monthly, up to 3 months
Assessment of Language with LAST (Language Screening Test)
admission and monthly, up to 3 months
Neuropsychological Assessment 8
Time Frame: admission and monthly, up to 3 months
Assessment of Aphasia with BDAE (Boston Diagnostic Aphasia Examination)
admission and monthly, up to 3 months
Neuropsychological Assessment 10
Time Frame: admission and monthly, up to 3 months
Assessment of depression with ADRS (Aphasia Depression Rating Scale)
admission and monthly, up to 3 months
Falls
Time Frame: at discharge, the number of falls is totalized
Monitoring of falls occuring during the hospitalization
at discharge, the number of falls is totalized
Visual field defect (hemianopia/quadranopia)
Time Frame: admission and monthly, up to 3 months
standardized clinical examination
admission and monthly, up to 3 months
Identification of brain structures involved in the stroke
Time Frame: once, at 2 month
anatomical MRI
once, at 2 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 38RC17.126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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