- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03203109
Determinants of Balance Recovery After Stroke - Retrospective Study (DOBRAS-R)
Determinants of Balance Recovery After Stroke
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Publications and helpful links
General Publications
- Pérennou D, Chauvin A, Piscicelli C, Hugues A, Dai S; Collaborators for the posturography study in the Determinants of Balance Recovery After Stroke (DOBRAS) cohort. Determining an optimal posturography dataset to identify standing behaviors in the post-stroke subacute phase. Cross-sectional study. Ann Phys Rehabil Med. 2022 Sep 28:101707. doi: 10.1016/j.rehab.2022.101707. [Epub ahead of print]
- Dai S, Piscicelli C, Clarac E, Baciu M, Hommel M, Perennou D. Lateropulsion After Hemispheric Stroke: A Form of Spatial Neglect Involving Graviception. Neurology. 2021 Apr 27;96(17):e2160-e2171. doi: 10.1212/WNL.0000000000011826. Epub 2021 Mar 15.
- Dai S, Piscicelli C, Lemaire C, Christiaens A, Schotten MT, Hommel M, Krainik A, Detante O, Perennou D. Recovery of balance and gait after stroke is deteriorated by confluent white matter hyperintensities: Cohort study. Ann Phys Rehabil Med. 2022 Jan;65(1):101488. doi: 10.1016/j.rehab.2021.101488. Epub 2021 Nov 11.
- Dai S, Piscicelli C, Clarac E, Baciu M, Hommel M, Perennou D. Balance, Lateropulsion, and Gait Disorders in Subacute Stroke. Neurology. 2021 Apr 27;96(17):e2147-e2159. doi: 10.1212/WNL.0000000000011152. Epub 2020 Nov 11.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC17.126
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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