Clinical Trials Logo
  1. Home
  2. Disorders of Consciousness
  3. NCT04706689

Development and Validation of the SWADOC Tool

Dysphagia Clinical Trial

Official title:
The Development and Validation of the SWADOC Tool: A Study Protocol for a Multicentric Prospective Cohort Study

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04706689
Study type Observational
Source University of Liege
Contact Evelyne Mélotte, M.D.
Phone 00323663915
Email evelyne.melotte@chuliege.be
Status Recruiting
Phase
Start date July 24, 2020
Completion date June 30, 2025
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03711474 - Dysphagia Following Anterior Cervical Spine Surgery; Single Dose Steroid vs Saline (DysDexVSSal) Phase 4
Enrolling by invitation NCT04074356 - Non-invasive Markers of Esophageal Function in Adults N/A
Suspended NCT04349462 - Post Critical Illness Dysphagia in the Intensive Care Unit N/A
Not yet recruiting NCT05982977 - Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training in Oral Dysphagia of Stroke N/A
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Active, not recruiting NCT03455608 - PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer N/A
Active, not recruiting NCT03604822 - Music Therapy Protocol to Support Bulbar and Respiratory Functions in ALS N/A
Recruiting NCT03682081 - Interventions for Patients With Alzheimer's Disease and Dysphagia N/A
Completed NCT05700838 - Refining Cough Skill Training in Parkinson's Disease and Dysphagia Phase 1
Not yet recruiting NCT04064333 - Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care N/A
Not yet recruiting NCT02724761 - Prophylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion N/A
Completed NCT02927691 - Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial Phase 2
Completed NCT01919112 - Fostering Eating After Stroke With Transcranial Direct Current Stimulation N/A
Completed NCT01370083 - Tongue Pressure Profile Training for Dysphagia Post Stroke Phase 2
Completed NCT01723358 - Neuromuscular Electrical Stimulation (NMES) Treatment Technique Therapy in the Management of Young Infants With Severe Dysphagia Phase 2
Withdrawn NCT01200147 - Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation N/A
Completed NCT00570557 - Development of a Web-Based Course to Maintain Skills in Nurses Trained to Screen for Dysphagia N/A
Recruiting NCT00166751 - Sonographic Assessment of Laryngeal Elevation N/A
Completed NCT01476241 - Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist N/A
Completed NCT00717028 - Functional Endoscopic Evaluation of Swallowing N/A