Determinants of Balance Recovery After Stroke - Retrospective Study

Stroke Clinical Trial

— DOBRAS-R  

Official title:

Determinants of Balance Recovery After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203109
• Other study ID #: 38RC17.126
• Status: Completed
• Start date: January 2012
• Est. completion date: October 31, 2019

Study information

• Verified date: November 2019
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posture	Change from Baseline Score of Postural Assessment Scale for Stroke (PASS) at discharge	admission and monthly, up to 3 months
Secondary	Balance	Assessment of Balance and Posture with SCP (Scale for Contraversive Pushing)	admission and monthly, up to 3 months
Secondary	Gait	Assessment of Gait with Lindmark test	admission and monthly, up to 3 months
Secondary	Postural disorders	Assessment of Postural control with CDP (Computerized posturography)	admission and monthly, up to 3 months
Secondary	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.	admission and monthly, up to 3 months
Secondary	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.	admission and monthly, up to 3 months
Secondary	Walking distance	Assessment of walking distance with the 6-minute-walking-test (6-MWT)	admission and monthly, up to 3 months
Secondary	Gait velocity	Assessment of gait velocity at self-prefered-velocity on 10 meters	admission and monthly, up to 3 months
Secondary	Pressure sensitivity (Hand and foot)	Assessment of hypoesthesia with Semmes-Weinstein monofilaments test	admission and monthly, up to 3 months
Secondary	Spasticity	Assessment of Spasticity with Ashworth Scale	admission and monthly, up to 3 months
Secondary	Laterality	Assessment of Laterality with Edinburgh Handedness Inventory	admission and monthly, up to 3 months
Secondary	Disability	Assessment of Autonomy with FIM (Functional Independence Measure)	admission and monthly, up to 3 months
Secondary	Neuropsychological Assessment 1	Assessment of Hemispatial Neglect with the Catherine Bergego Scale (CBS)	admission and monthly, up to 3 months
Secondary	Neuropsychological Assessment 2	Assessment of Hemispatial Neglect with the fluff Test	admission and monthly, up to 3 months
Secondary	Neuropsychological Assessment 3	Assessment of Hemispatial Neglect using 'thumb localizing test' (TLT)	admission and monthly, up to 3 months
Secondary	Neuropsychological Assessment 4	Assessment of Hemispatial Neglect with the 'Comb and Razor Test'	admission and monthly, up to 3 months
Secondary	Neuropsychological Assessment 5	Assessment of Hemispatial Neglect with the BEN ( Battery of tests for the quantitative assessment of unilateral neglect)	admission and monthly, up to 3 months
Secondary	Neuropsychological Assessment 6	Assessment of Apraxia with ATS (Apraxia Screen of TULIA)	admission and monthly, up to 3 months
Secondary	Neuropsychological Assessment 7	Assessment of Language with LAST (Language Screening Test)	admission and monthly, up to 3 months
Secondary	Neuropsychological Assessment 8	Assessment of Aphasia with BDAE (Boston Diagnostic Aphasia Examination)	admission and monthly, up to 3 months
Secondary	Neuropsychological Assessment 10	Assessment of depression with ADRS (Aphasia Depression Rating Scale)	admission and monthly, up to 3 months
Secondary	Falls	Monitoring of falls occuring during the hospitalization	at discharge, the number of falls is totalized
Secondary	Visual field defect (hemianopia/quadranopia)	standardized clinical examination	admission and monthly, up to 3 months
Secondary	Identification of brain structures involved in the stroke	anatomical MRI	once, at 2 month