Validation Study of SCALA, Scale for Lateropulsion
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About
Development and clinical validation of SCALA, a new rating scale for lateropulsion after stroke. A monocentric clinical study including 78 post-stroke individuals and 30 patients without stroke and/or healthy volunteers.
In order to analyze the SCALA's content validity, a Delphi-type consensus process was applied prior to clinical validation. The Delphi process, including 20 international experts, has given rise to the version of the scale to be tested clinically (SCALA-V1; Paper in preparation).
Full 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 clinometric properties than the 2 main existing scales, the Scale for Contraversive Pushing (SCP) and the Burke Lateropulsion Scale (BLS), and by the need to have a unicist scale to assess all components of lateropulsion (i.e. body tilt, active pushing by non-paretic limbs and resistance to passive correction) regardless the mechanisms or the severity of lateropulsion and the side of the stroke lesion.
The initial version (version 0) of the scale has been developed by our team in Grenoble (SCALA-V0). In a first step, an online expert consensus process (Delphi method) will give rise to a version 1 (SCALA-V1), considered as generally accepted by the scientific community.
The SCALA-V1 will be validated in a monocentric clinical study. 78 individuals with stroke and 30 individuals without stroke and/or healthy controls will be included.
All subjects will be comprehensively assessed during 3 weeks. During the first week will be performed many assessments used in routine in our center. These assessments will serve to describe participants and ensure that our series is comparable to others of the literature. These assessments which are not considered as outcome are: age, sex, height, weight, manual laterality, comorbidity, apraxia, executive function deficits, retropulsion, depression, and autonomy. Several other clinical assessments will also be performed during the first week, this time to serve as outcomes: stroke lesion characteristics, motor weakness, spasticity, spatial neglect, anosognosia, aphasia, hemianopsia, hypoesthesia, visual verticality, balance and gait disorders. During the second week, lateropulsion by SCALA-V1, verticality perception and spatial representation will be assessed to determine their inter-rater reliability. During the last week, mass distribution on lower limbs in frontal plan during standing position and body orientation in frontal plan during sitting position, standing position and sit-to-stand will be assessed.
Editorial valorization of the clinical trial: This study will be valorized by several papers, one concerning clinometric properties of SCALA-V1 (reliability ...), other(s) paper(s) about the understanding of lateropulsion, and clinometric properties of the devices assessing vertical perception and body orientation.
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Inclusion and exclusion criteria
Inclusion Criteria: All types of stroke, ≤6 months.
Exclusion Criteria: postural disorders other than stroke or body geometry disorders (e.g. limb amputation, severe deformity, bone fracture, trunk deformity with deviation of C7 greater than 30mm) interfering with balance, acute vertigo, history of severe psychiatric disease, medical instability, dementia diagnosed, and severe understanding deficits limiting assessments.
Trial design
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Interventional model
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108 participants in 2 patient groups
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Central trial contact
Aurélien Hugues, PT, PhD; Dominic Pérennou, MD, PhD
Data sourced from clinicaltrials.gov
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