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StrokeDOBRAS-RNCT03203109

Determinants of Balance Recovery After Stroke - Retrospective Study

An observational study of Stroke, run by University Hospital, Grenoble.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke
What is being tested?
Postural Assessment Scale for Stroke (PASS)
How many people
300 participants
Where
No sites listed yet
Study dates
Jan 2012to 31 Oct 2019
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: consecutive patients admitted in neurorehabilitation ward after first hemispheric stroke

Who may be able to join

  • first hemispheric stroke patient non-opposed to inclusion

Who cannot join

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

About this study

Official title: 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.

Read the 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.

Conditions
Stroke
Being tested
Postural Assessment Scale for Stroke (PASS)
Keywords
lateropulsion, pusher syndrome, posture, balance, PASS, verticality perception, gait
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Postural Assessment Scale for Stroke (PASS)Behavioural

    Postural Assessment Scale for Stroke (PASS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Posture

    Change from Baseline Score of Postural Assessment Scale for Stroke (PASS) at discharge

    Measured: admission and monthly, up to 3 months

Secondary outcomes (23)

  1. Balance

    Assessment of Balance and Posture with SCP (Scale for Contraversive Pushing)

    Measured: admission and monthly, up to 3 months

  2. Gait

    Assessment of Gait with Lindmark test

    Measured: admission and monthly, up to 3 months

  3. Postural disorders

    Assessment of Postural control with CDP (Computerized posturography)

    Measured: admission and monthly, up to 3 months

  4. Visual vertical perception

    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.

    Measured: admission and monthly, up to 3 months

  5. Postural vertical perception

    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.

    Measured: admission and monthly, up to 3 months

  6. Walking distance

    Assessment of walking distance with the 6-minute-walking-test (6-MWT)

    Measured: admission and monthly, up to 3 months

  7. Gait velocity

    Assessment of gait velocity at self-prefered-velocity on 10 meters

    Measured: admission and monthly, up to 3 months

  8. Pressure sensitivity (Hand and foot)

    Assessment of hypoesthesia with Semmes-Weinstein monofilaments test

    Measured: admission and monthly, up to 3 months

  9. Spasticity

    Assessment of Spasticity with Ashworth Scale

    Measured: admission and monthly, up to 3 months

  10. Laterality

    Assessment of Laterality with Edinburgh Handedness Inventory

    Measured: admission and monthly, up to 3 months

  11. Disability

    Assessment of Autonomy with FIM (Functional Independence Measure)

    Measured: admission and monthly, up to 3 months

  12. Neuropsychological Assessment 1

    Assessment of Hemispatial Neglect with the Catherine Bergego Scale (CBS)

    Measured: admission and monthly, up to 3 months

  13. Neuropsychological Assessment 2

    Assessment of Hemispatial Neglect with the fluff Test

    Measured: admission and monthly, up to 3 months

  14. Neuropsychological Assessment 3

    Assessment of Hemispatial Neglect using 'thumb localizing test' (TLT)

    Measured: admission and monthly, up to 3 months

  15. Neuropsychological Assessment 4

    Assessment of Hemispatial Neglect with the 'Comb and Razor Test'

    Measured: admission and monthly, up to 3 months

  16. Neuropsychological Assessment 5

    Assessment of Hemispatial Neglect with the BEN ( Battery of tests for the quantitative assessment of unilateral neglect)

    Measured: admission and monthly, up to 3 months

  17. Neuropsychological Assessment 6

    Assessment of Apraxia with ATS (Apraxia Screen of TULIA)

    Measured: admission and monthly, up to 3 months

  18. Neuropsychological Assessment 7

    Assessment of Language with LAST (Language Screening Test)

    Measured: admission and monthly, up to 3 months

  19. Neuropsychological Assessment 8

    Assessment of Aphasia with BDAE (Boston Diagnostic Aphasia Examination)

    Measured: admission and monthly, up to 3 months

  20. Neuropsychological Assessment 10

    Assessment of depression with ADRS (Aphasia Depression Rating Scale)

    Measured: admission and monthly, up to 3 months

  21. Falls

    Monitoring of falls occuring during the hospitalization

    Measured: at discharge, the number of falls is totalized

  22. Visual field defect (hemianopia/quadranopia)

    standardized clinical examination

    Measured: admission and monthly, up to 3 months

  23. Identification of brain structures involved in the stroke

    anatomical MRI

    Measured: once, at 2 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2017
  2. Study startJan 2012
  3. Primary completion31 Oct 2019
  4. Study completion31 Oct 2019

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03203109
Sponsor's protocol ID
38RC17.126
Acronym
DOBRAS-R
Status last verified
Nov 2019
First submitted
2 May 2017
Last updated
8 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lafitte R, Diaine F, Dai S, Carre O, Dupierrix E, Jolly C, Piscicelli C, Perennou D. Writing and drawing tilts after right hemisphere stroke are signs of a wrong verticality representation. Ann Phys Rehabil Med. 2025 May;68(4):101923. doi: 10.1016/j.rehab.2024.101923. Epub 2025 Jan 15.

    PubMed 39818122

  • Dai S, Piscicelli C, Marquer A, Lafitte R, Clarac E, Detante O, Perennou D. Improving orientation with respect to gravity enhances balance and gait recovery after stroke: DOBRAS cohort. Ann Phys Rehabil Med. 2024 Feb;67(1):101767. doi: 10.1016/j.rehab.2023.101767. Epub 2024 Jan 23.

    PubMed 38266575

  • Perennou D, Chauvin A, Piscicelli C; Collaborators for the posturography study in the Determinants of Balance Recovery After Stroke (DOBRAS) cohort; Hugues A, Dai S. Determining an optimal posturography dataset to identify standing behaviors in the post-stroke subacute phase. Cross-sectional study. Ann Phys Rehabil Med. 2023 May;66(4):101707. doi: 10.1016/j.rehab.2022.101707. Epub 2023 Jan 4.

    PubMed 36182062

  • 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.

    PubMed 33722996

  • 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.

    PubMed 33450367

  • 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.

    PubMed 33177223

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by University Hospital, Grenoble.

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 8 Nov 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?

Posture (time frame: admission and monthly, up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03203109, which also lists 6 linked publications.

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 8 Nov 2019.

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