Validation Study of SCALA, Scale for Lateropulsion (SCALA)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: SCALA

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominic Pérennou, MD, PhD; Phone Number: 0033 4 76767575; Email: DPerennou@chu-grenoble.fr
• Study Contact Backup: Name: Aurélien Hugues, PT, PhD; Phone Number: 0033 4 76767575; Email: ahugues@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France
    • Recruiting
    • Grenoble University Hospital
    • Contact: Dominic Pérennou, MD, PhD; Email: dperennou@chu-grenoble.fr
    • Contact: Aurélien Hugues, PT, PhD; Email: ahugues@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stroke; stroke patients, application of SCALA	Device: SCALA; All items of SCALA are applied
Experimental: control; Healthy individuals (patients without stroke), application of SCALA	Device: SCALA; All items of SCALA are applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCALA Reliability	Inter-rater reliability, internal consistency, measurement error of SCALA	week 2 (assessed twice +/-2d)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of vision on lateropulsion	Comparison of scores of items performed with and without vision	week 2
Interest of the condition without vision on the lateropulsion diagnosis from the SCALA total score.	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	week 2
Evaluation of SCALA feasibility	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"	Week 2
To improve the understanding of mechanisms underpinning lateropulsion	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.	weeks 1,2 and 3
Reliability of supplementary instrumental assessments of lateropulsion	Inter-rater reliability of longitudinal body axis representation and postural verticality perception	Week 2 (assessed twice +/-2d)
Criterion validity of SCALA	Comparison to Scale for Contraversive Pushing and Burke Lateropulsion Scale, which currently are considered as gold-standards to assess lateropulsion.	Weeks 1 and 2
Descriptive analysis of data of individuals with stroke	Descriptive analysis of data	Weeks 1, 2 and 3
Descriptive analysis of data of healthy controls	Descriptive analysis of data including normality ranges.	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Dominic Pérennou, MD, PhD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 7, 2016
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: stroke; lateropulsion; Pusher syndrome
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 38RC16.088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No