Validation Study of SCALA, Scale for Lateropulsion

NCT03077399 | Completed DMC

• 1 other identifier: 38RC16.088
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Stroke

Keywords

lateropulsion; stroke; Pusher syndrome

Outcome Measures

Primary Outcomes (1)

• SCALA Reliability

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

  week 2 (assessed twice +/-2d)

Secondary Outcomes (8)

• Influence of vision on lateropulsion

  week 2

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

  week 2

• Evaluation of SCALA feasibility

  Week 2

• To improve the understanding of mechanisms underpinning lateropulsion

  weeks 1,2 and 3

• Reliability of supplementary instrumental assessments of lateropulsion

  Week 2 (assessed twice +/-2d)

Study Arms (2)

stroke

EXPERIMENTAL

stroke patients, application of SCALA

Device: SCALA

control

EXPERIMENTAL

Healthy individuals (patients without stroke), application of SCALA

Device: SCALA

Interventions

SCALA DEVICE

All items of SCALA are applied

control; stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble University Hospital

Grenoble, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dominic Pérennou, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a monocentric observational clinical study. During the first week, the assessments used in routine in our center will be performed. During the second week, the assessments of lateropulsion by SCALA-V1, postural verticality perception in sitting and the representation of longitudinal body axis in lying position will be performed twice, 2 days apart, by 2 different raters in order to determine their inter-rater reliability. During the third 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.

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: March 13, 2017
• Study Start: September 1, 2022
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)