Development and Validation of the SWADOC Tool
- Conditions
- Swallowing DisordersDysphagiaAssessment ToolDisorders of ConsciousnessSpeech Therapy
- Interventions
- Behavioral: SWADOC toolBehavioral: FOTT-SAS
- Registration Number
- NCT04706689
- Lead Sponsor
- University of Liege
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 104
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Minimally conscious patients PLUS FOTT-SAS The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R). Minimally conscious patients MINUS (MCS-) FOTT-SAS The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R). Patients emerging from the minimally conscious state (EMCS) FOTT-SAS The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R). Unresponsive wakefulness syndrome patients (UWS) FOTT-SAS The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R). Unresponsive wakefulness syndrome patients (UWS) SWADOC tool The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R). Minimally conscious patients MINUS (MCS-) SWADOC tool The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R). Minimally conscious patients PLUS SWADOC tool The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R). Patients emerging from the minimally conscious state (EMCS) SWADOC tool The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).
- Primary Outcome Measures
Name Time Method Change in the SWADOC-scored during three sessions (Examiner 1) - Intra-reliability 15-25 minutes (3 times in 5 business days) The SWallowing Assessment in Disorders Of Consciousness (SWADOC) tool is composed of an average of 50 qualitative and quantitative items. The subsection "SWADOC-scored" includes the 8 quantitative items. Four items are linked to the oral phase and four to the pharyngeal phase. For each quantitative item, patient's abilities are rated on a four-level severity scale ranging from 0 to 3. These levels correspond to item scores that can be added together to calculate 3 performance scores: the oral phase sub-score (sum of the 4 oral item scores - minimum of 0, maximum of 12), the pharyngeal phase sub-score (sum of the 4 pharyngeal item scores - minimum of 0, maximum of 12) and the total swallowing score (sum of the 8 item scores - minimum of 0, maximum of 24).
The better the score is, the better the swallowing is.SECONDs 7 minutes (immediately before or after the SWADOC tool in each of the three sessions) The Simplified Evaluation of CONsciousness Disorders (SECONDs): it features a shorter administration time (median of 7 minutes) and required only a mirror as material. It consists of 8 items: observation and reporting spontaneous behaviors, response to command, communication, visual pursuit and fixation, pain localization, oriented behaviors and arousal. The SECONDs provides a total score directly reflecting one diagnosis (0 = coma, 1 = UWS, 2-5 = MCS-, 6-7 = MCS+, 8 = EMCS). The better the score is, the better the consciousness level is.
- Secondary Outcome Measures
Name Time Method FOTT-SAS (Examiner 1) Immediately after one of the three sessions FOTT-SAS (Facial Oral Tract Therapy Swallowing Assessment of Saliva) The FOTT-SAS is a reliable assessment for detecting aspiration risk in patients with acquired brain injury.
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 better the score is, the better the swallowing is, minimum of 0, maximum of 7).
The observations made during the assessment will permit to score the FOTT-SAS and verify the concurrent validity of the SWADOC tool.SWADOC-scored by Examiner 2 (inter-reliability) 15-25 minutes - immediately before or after one of the three sessions The SWallowing Assessment in Disorders Of Consciousness (SWADOC) tool is composed of an average of 50 qualitative and quantitative items. The subsection "SWADOC-scored" includes the 8 quantitative items. Four items are linked to the oral phase and four to the pharyngeal phase. For each quantitative item, patient's abilities are rated on a four-level severity scale ranging from 0 to 3. These levels correspond to item scores that can be added together to calculate 3 performance scores: the oral phase sub-score (sum of the 4 oral item scores - minimum of 0, maximum of 12), the pharyngeal phase sub-score (sum of the 4 pharyngeal item scores - minimum of 0, maximum of 12) and the total swallowing score (sum of the 8 item scores - minimum of 0, maximum of 24). The better the score is, the better the swallowing is.
Trial Locations
- Locations (8)
Centre du Cerveau², University Hospital of Liège
🇧🇪Liège, Belgium
Cliniques de Soins Spécialisés Valdor-Pèrî
🇧🇪Liège, Belgium
Centre neurologique et de réadaptation fonctionnelle de Fraiture-en-Condroz
🇧🇪Fraiture, Belgium
Centre de Traumatologie et de Réadaptation de Jette (Erasme, ULB)
🇧🇪Jette, Belgium
Centre Hospitalier Neurologique William Lennox (UCL)
🇧🇪Ottignies-Louvain-la-Neuve, Brabant Wallon, Belgium
Fontfroide functional re-education centre
🇫🇷Montpellier, France
Uzès hospital
🇫🇷Uzès, France
CHU Nîmes
🇫🇷Nîmes, France