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Validation Study of SCALA, Scale for Lateropulsion (SCALA)

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ClinicalTrials.gov Identifier: NCT03077399
Recruitment Status : Unknown
Verified March 2017 by University Hospital, Grenoble.
Recruitment status was:  Not yet recruiting
First Posted : March 13, 2017
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date October 7, 2016
First Posted Date March 13, 2017
Last Update Posted Date March 15, 2017
Estimated Study Start Date April 2017
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 6, 2017)
Correlation of SCALA score with SCP-score at admission [ Time Frame: 60d ]
Validity of SCALA versus actual gold standard (scale SCP)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03077399 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 6, 2017)
Evaluation of SCALA sensitivity [ Time Frame: 60d ]
application of Scale at different time ponts (from d30 to d90)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation Study of SCALA, Scale for Lateropulsion
Official Title Clinical Validation of SCALA, a New Rating Scale for Assessing Lateropulsion After Stroke
Brief Summary

Development and clinical validation of SCALA, a new rating scale for lateropulsion after stroke. A monocentric controlled study including 60 patients post-stroke and 40 patients without stroke and/or healthy volunteers..

In order to analyze the SCALA's content validity, a Delphi-type consensus process will be applied prior to clinical validation. The Delphi process, including 20 international experts, will give rise to the version of the scale to be tested clinically.

Detailed Description

The protocol aims to develop and validate a new clinical rating scale assessing lateropulsion after stroke. The project is driven by the need to have a tool that better meets clinimetric properties than the 2 main existing scales, the Scale for Contraversive Pushing (SCP) and the Burke Lateropulsion Scale (BLS).

The initial version (version 0) of the scale has been developped by our team in Grenoble.

In a first step, an online expert consensus process (Delphi method) will give rise to a version 1, considered as generally accepted by the scientific community.

The SCALA version 1 will be validated in a monocentric clinical study. 60 patients and 40 patients without stroke and/or healthy controls will be included.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients after stroke (up to 30d post-stroke)
Condition Stroke
Intervention Device: SCALA
All items of SCALA are applied
Study Groups/Cohorts
  • stroke
    stroke patients, application of SCALA
    Intervention: Device: SCALA
  • control
    patients without stroke, application of SCALA
    Intervention: Device: SCALA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 6, 2017)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

post stroke (<30d)

Exclusion Criteria:

neurological conditions interfering with balance acute vertigo postural asymmetry or scoliosis for reasons other than stroke

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03077399
Other Study ID Numbers 38RC16.088
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Grenoble
Study Sponsor University Hospital, Grenoble
Collaborators Not Provided
Investigators
Principal Investigator: Dominic Pérennou University Hospital, Grenoble
PRS Account University Hospital, Grenoble
Verification Date March 2017