Development and Validation of the SWADOC Tool

Summary

Background: After a period of coma, patients with severe brain injury may present disorders of consciousness (DOC). A wide proportion of these patients also suffer from severe dysphagia. Assessment and therapy of swallowing disabilities of DOC patients are essential because dysphagia has major functional consequences and comorbidities. Dysphagia evaluation in patients with DOC is hampered by the lack of adapted tools. The first aim of the study was to develop a new tool, the SWallowing Assessment in Disorders Of Consciousness (SWADOC), and propose a validation protocol. The SWADOC tool has been developed to help therapists to apprehend components related to swallowing in patients with DOC. The second aim is to appreciate the relationship between patients' level of consciousness and SWADOC items and scores.

Method/design: In this multicentric prospective cohort, 104 patients with DOC will be tested three times during two consecutive days with the SWADOC tool. Statistical analyses will focus on the reliability and validity of the SWADOC tool, especially the intra and inter-rater reliability, internal consistency, measures of dispersion and concurrent validity with the FOTT Swallowing Assessment of Saliva (FOTT-SAS). The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorders (SECONDs) and the Coma Recovery Scale-Revised (CRS-R)

Discussion: The assessment of swallowing abilities among patients with DOC is the first necessary step towards the development of an individualized dysphagia care plan. A validated scoring tool will be essential for clinicians to better apprehend dysphagia in DOC patients and to document the evolution of their disorders.

Conditions

• Swallowing Disorders
• Dysphagia
• Disorders of Consciousness
• Assessment Tool
• Speech Therapy

Interventions

BEHAVIORAL

SWADOC tool

The tool explores some oral and pharyngeal components of swallowing as well as a range of prerequisite and related components of swallowing in DOC patients. It is composed of an average of 50 qualitative items and a subsection named "SWADOC-scored" comprising 8 quantitative items.

BEHAVIORAL

FOTT-SAS

Facial Oral Tract Therapy Swallowing Assessment of Saliva : the results of the SWADOC-scored in one of the sessions will be compared to the FOTT Swallowing Assessment of Saliva (FOTT-SAS) (27). The test is based on 7 questions under which if items 1-4 are answered "Yes" and items 5-7 are answered "No", oral intake should be initiated. The FOTT-SAS includes items that can be scored based on the administration of the SWADOC tool. In that respect, no additional administration will be required

Sponsors & Collaborators

• Centre du Cerveau², Centre hospitalier universitaire de Liège

  collaborator UNKNOWN

• Centre de Traumatologie et de Réadaptation de Jette (Erasme, ULB)

  collaborator UNKNOWN

• Cliniques de Soins Spécialisés Valdor-Pèrî

  collaborator UNKNOWN

• Centre Hospitalier Neurologique William Lennox (UCL)

  collaborator UNKNOWN

• Centre Hospitalier Universitaire de Liege

  collaborator OTHER

• Centre Hospitalier Universitaire de Nīmes

  collaborator OTHER

• Uzès hospital

  collaborator UNKNOWN

• Fontfroide functional re-education centre, Montpellier, France

  collaborator UNKNOWN

• University of Liege

  lead OTHER

Principal Investigators

• Olivia Gosseries, PhD · University of Liege, Giga Consciousness

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-24

Primary Completion

2024-12-31

Completion

2025-06-30

Countries

• Belgium
• France

Study Locations