Validation Study of SCALA, Scale for Lateropulsion

• Sponsor: University Hospital, Grenoble (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT03077399
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: SCALA	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Clinical Validation of SCALA, a New Rating Scale for Assessing Lateropulsion After Stroke
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: stroke stroke patients, application of SCALA	Device: SCALA; All items of SCALA are applied
Experimental: control patients without stroke, application of SCALA	Device: SCALA; All items of SCALA are applied

Outcome Measures

Primary Outcome Measures

1. SCALA validation [60d]

   Reliability and internal consistency of SCALA

Secondary Outcome Measures

1. Evaluation of SCALA sensitivity [60d]

   application of Scale at different time ponts (from d30 to d90)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

post stroke (<30d)

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grenoble University Hospital	Grenoble		France

Sponsors and Collaborators

• University Hospital, Grenoble

Investigators

• Principal Investigator: Dominic Pérennou, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT03077399
• Other Study ID Numbers: 38RC16.088
• First Posted: Mar 13, 2017
• Last Update Posted: Oct 4, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Grenoble: lateropulsion; stroke; Pusher syndrome
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Oct 4, 2021