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Completed

NCT Number: NCT03077399

Validation Study of SCALA, Scale for Lateropulsion

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grenoble University Hospital

Grenoble, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SCALA

Device

All items of SCALA are applied

Primary outcomes

  1. SCALA Reliability

    Time frame: week 2 (assessed twice +/-2d)

    Inter-rater reliability, internal consistency, measurement error of SCALA

Secondary outcomes

  1. Influence of vision on lateropulsion

    Time frame: week 2

    Comparison of scores of items performed with and without vision

  2. Interest of the condition without vision on the lateropulsion diagnosis from the SCALA total score.

    Time frame: week 2

    Comparison of proportion of individuals with a lateropulsion by using the total score of SCALA based on all items (with and without vision) and that of individuals with a lateropulsion by using the total score of SCALA based only on items with vision

  3. Evaluation of SCALA feasibility

    Time frame: Week 2

    Influence of sensory-motor, language and cognitive deficits, severity of balance and gait disorders, and stroke features (type and localization) on the time required to complete SCALA; Descriptive statistics on items judged as "not applicable"

  4. To improve the understanding of mechanisms underpinning lateropulsion

    Time frame: weeks 1,2 and 3

    Relation between the total score or subscores of SCALA, and stroke lesion characteristics, verticality perception, representation of longitudinal body axis in lying position, body orientation in frontal plan, weight-bearing asymmetry, and awareness of deficits.

  5. Reliability of supplementary instrumental assessments of lateropulsion

    Time frame: Week 2 (assessed twice +/-2d)

    Inter-rater reliability of longitudinal body axis representation and postural verticality perception

  6. Criterion validity of SCALA

    Time frame: Weeks 1 and 2

    Comparison to Scale for Contraversive Pushing and Burke Lateropulsion Scale, which currently are considered as gold-standards to assess lateropulsion.

  7. Descriptive analysis of data of individuals with stroke

    Time frame: Weeks 1, 2 and 3

    Descriptive analysis of data

  8. Descriptive analysis of data of healthy controls

    Time frame: Day 1

    Descriptive analysis of data including normality ranges.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Clinical Validation of SCALA, a New Rating Scale for Assessing Lateropulsion After Stroke

Acronym: SCALA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2017
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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