DOBRAS-R: Determinants of Balance Recovery After Stroke - Retrospective Study

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Completed
CT.gov ID
NCT03203109
Collaborator
(none)
300
94

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Jan 1, 2012
Actual Primary Completion Date :
Oct 31, 2019
Actual Study Completion Date :
Oct 31, 2019

Outcome Measures

Primary Outcome Measures

  1. Posture [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 [admission and monthly, up to 3 months]

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

  2. Gait [admission and monthly, up to 3 months]

    Assessment of Gait with Lindmark test

  3. Postural disorders [admission and monthly, up to 3 months]

    Assessment of Postural control with CDP (Computerized posturography)

  4. Visual vertical perception [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 [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 [admission and monthly, up to 3 months]

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

  7. Gait velocity [admission and monthly, up to 3 months]

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

  8. Pressure sensitivity (Hand and foot) [admission and monthly, up to 3 months]

    Assessment of hypoesthesia with Semmes-Weinstein monofilaments test

  9. Spasticity [admission and monthly, up to 3 months]

    Assessment of Spasticity with Ashworth Scale

  10. Laterality [admission and monthly, up to 3 months]

    Assessment of Laterality with Edinburgh Handedness Inventory

  11. Disability [admission and monthly, up to 3 months]

    Assessment of Autonomy with FIM (Functional Independence Measure)

  12. Neuropsychological Assessment 1 [admission and monthly, up to 3 months]

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

  13. Neuropsychological Assessment 2 [admission and monthly, up to 3 months]

    Assessment of Hemispatial Neglect with the fluff Test

  14. Neuropsychological Assessment 3 [admission and monthly, up to 3 months]

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

  15. Neuropsychological Assessment 4 [admission and monthly, up to 3 months]

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

  16. Neuropsychological Assessment 5 [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 [admission and monthly, up to 3 months]

    Assessment of Apraxia with ATS (Apraxia Screen of TULIA)

  18. Neuropsychological Assessment 7 [admission and monthly, up to 3 months]

    Assessment of Language with LAST (Language Screening Test)

  19. Neuropsychological Assessment 8 [admission and monthly, up to 3 months]

    Assessment of Aphasia with BDAE (Boston Diagnostic Aphasia Examination)

  20. Neuropsychological Assessment 10 [admission and monthly, up to 3 months]

    Assessment of depression with ADRS (Aphasia Depression Rating Scale)

  21. Falls [at discharge, the number of falls is totalized]

    Monitoring of falls occuring during the hospitalization

  22. Visual field defect (hemianopia/quadranopia) [admission and monthly, up to 3 months]

    standardized clinical examination

  23. Identification of brain structures involved in the stroke [once, at 2 month]

    anatomical MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

  • Principal Investigator: Dominic PĂ©rennou, MD PhD, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT03203109
Other Study ID Numbers:
  • 38RC17.126
First Posted:
Jun 29, 2017
Last Update Posted:
Nov 8, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Grenoble
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 8, 2019