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

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ClinicalTrials.gov Identifier: NCT03203109
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief 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.

Condition or disease Intervention/treatment
Stroke Behavioral: Postural Assessment Scale for Stroke (PASS)

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.

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Determinants of Balance Recovery After Stroke
Actual Study Start Date : January 2012
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : October 31, 2019

Intervention Details:
  • Behavioral: Postural Assessment Scale for Stroke (PASS)
    Postural Assessment Scale for Stroke (PASS)


Primary Outcome Measures :
  1. Posture [ Time Frame: admission and monthly, up to 3 months ]
    Change from Baseline Score of Postural Assessment Scale for Stroke (PASS) at discharge


Secondary Outcome Measures :
  1. Balance [ Time Frame: admission and monthly, up to 3 months ]
    Assessment of Balance and Posture with SCP (Scale for Contraversive Pushing)

  2. Gait [ Time Frame: admission and monthly, up to 3 months ]
    Assessment of Gait with Lindmark test

  3. Postural disorders [ Time Frame: admission and monthly, up to 3 months ]
    Assessment of Postural control with CDP (Computerized posturography)

  4. 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.

  5. 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.

  6. Walking distance [ Time Frame: admission and monthly, up to 3 months ]
    Assessment of walking distance with the 6-minute-walking-test (6-MWT)

  7. Gait velocity [ Time Frame: admission and monthly, up to 3 months ]
    Assessment of gait velocity at self-prefered-velocity on 10 meters

  8. Pressure sensitivity (Hand and foot) [ Time Frame: admission and monthly, up to 3 months ]
    Assessment of hypoesthesia with Semmes-Weinstein monofilaments test

  9. Spasticity [ Time Frame: admission and monthly, up to 3 months ]
    Assessment of Spasticity with Ashworth Scale

  10. Laterality [ Time Frame: admission and monthly, up to 3 months ]
    Assessment of Laterality with Edinburgh Handedness Inventory

  11. Disability [ Time Frame: admission and monthly, up to 3 months ]
    Assessment of Autonomy with FIM (Functional Independence Measure)

  12. Neuropsychological Assessment 1 [ Time Frame: admission and monthly, up to 3 months ]
    Assessment of Hemispatial Neglect with the Catherine Bergego Scale (CBS)

  13. Neuropsychological Assessment 2 [ Time Frame: admission and monthly, up to 3 months ]
    Assessment of Hemispatial Neglect with the fluff Test

  14. Neuropsychological Assessment 3 [ Time Frame: admission and monthly, up to 3 months ]
    Assessment of Hemispatial Neglect using 'thumb localizing test' (TLT)

  15. Neuropsychological Assessment 4 [ Time Frame: admission and monthly, up to 3 months ]
    Assessment of Hemispatial Neglect with the 'Comb and Razor Test'

  16. 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)

  17. Neuropsychological Assessment 6 [ Time Frame: admission and monthly, up to 3 months ]
    Assessment of Apraxia with ATS (Apraxia Screen of TULIA)

  18. Neuropsychological Assessment 7 [ Time Frame: admission and monthly, up to 3 months ]
    Assessment of Language with LAST (Language Screening Test)

  19. Neuropsychological Assessment 8 [ Time Frame: admission and monthly, up to 3 months ]
    Assessment of Aphasia with BDAE (Boston Diagnostic Aphasia Examination)

  20. Neuropsychological Assessment 10 [ Time Frame: admission and monthly, up to 3 months ]
    Assessment of depression with ADRS (Aphasia Depression Rating Scale)

  21. Falls [ Time Frame: at discharge, the number of falls is totalized ]
    Monitoring of falls occuring during the hospitalization

  22. Visual field defect (hemianopia/quadranopia) [ Time Frame: admission and monthly, up to 3 months ]
    standardized clinical examination

  23. Identification of brain structures involved in the stroke [ Time Frame: once, at 2 month ]
    anatomical MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
consecutive patients admitted in neurorehabilitation ward after first hemispheric stroke
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203109


Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Dominic Pérennou, MD PhD University Hospital, Grenoble
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03203109    
Other Study ID Numbers: 38RC17.126
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
lateropulsion
pusher syndrome
posture
balance
PASS
verticality perception
gait
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases