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Completed

NCT Number: NCT03203109

Determinants of Balance Recovery After Stroke - Retrospective Study

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postural Assessment Scale for Stroke (PASS)

Behavioral

Postural Assessment Scale for Stroke (PASS)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Determinants of Balance Recovery After Stroke

Acronym: DOBRAS-R

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Jun 29, 2017
Registry last updated
Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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