NCT03019432

Brief Summary

In this study, the researchers will investigate whether the E-effect is present in stroke subjects both on the subjective visual and postural vertical test. In addition, researchers will investigate the impact of the loss of different sensory information sources on the sensory reweighting strategies and perception of verticality by measuring the effect of somatosensory loss on the E-effect.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

1 month

First QC Date

January 9, 2017

Last Update Submit

January 16, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • Rivermead Assessment of Somatosensory Performance

    This test assesses several modalities of somatosensory performance such as sharp/dull discrimination; warm/cold; proprioception; 2-point discrimination.

    1 day

  • Subjective Visual Vertical Test (SVV)

    This test measures the ability of the subject to realign a laser bar with the earth vertical after the malalignment procedure. This test occurs in complete darkness to inhibit visual references. The device used for the projection is the Vertitest (Difra, Belgium).

    1 day

  • Subjective Postural Vertical Test

    This test measures the ability of the subject to realign a chair, at which the subject is seated, with the earth vertical after a malalignment procedure. This test occurs blindfolded to inhibit visual references. The tilting chair used for this test is custom made. The deviation/error of the realigned chair compared to the earth vertical is measured by a digital protractor.

    1 day

Interventions

perception of verticality measures SVV and SPV; somatosensory assessment RASP

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

stroke patients within 3 months poststroke hospitalized in a Belgian Rehabilitation Hospital

You may qualify if:

  • Adult first-stroke patients
  • Patients attending a rehabilitation program in the Rehabilitation Hospital Revarte, Belgium

You may not qualify if:

  • An age above 65
  • Neurological, except stroke, and orthopaedic impairments influencing outcome measures
  • Brainstem, cerebellar or multiple lesions
  • An ischemic or hemorrhagic etiology
  • Pre-existing co-morbid conditions that may affect vision and somatosensory function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Hospital Revarte

Wilrijk, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Sensation DisordersStrokeCerebrovascular Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Wim Saeys, Dr

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 12, 2017

Study Start

January 1, 2017

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations