Incidence and treatment of Clinically Significant Swallowing Dysfunction in Patients Treated in Halo-thoracic Brace for Cervical Spine Injury.

Not Applicable

• Conditions: Dysphagia; Cervical Spine Injury; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Musculoskeletal - Other muscular and skeletal disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12614000254695
• Lead Sponsor: Department of Trauma Services, The Alfred hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Aged 18 or above (ie => 18 years), male or female;
Patients admitted for cervical spinal injury requiring Halo-Thoracic orthosis;
Patients under the care of Orthopaedic or Neurosurgical spinal teams; and
Informed consent obtained.

Exclusion Criteria

Age less than 18 years (ie < 18 years);
Patients who have pre-exisiting medical co-morbidities complicated by dysfunctional swallow (ie progressive neurological disorders, achalasia or pre-existing dysmotility);
Patients with medical co-morbidities limiting feasibility and safety of videofluoroscopy;
Tracheostomised patients;
Uncooperative patients; and
Patients not consenting to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis of dysphagia and/or aspiration; and<br>Need of Halo-Thoracic orthosis adjustment.<br><br>Diagnosis of dysphagia or aspiration is performed by bedside assessment by speech pathologist, and also by videofluorscopic assessment (see earlier entry for details of this radiological examination).<br>Once the diagnosis of dysphagia or aspiration is confirmed on fluoroscopy, the decision is made, based on the level of dysphagia/aspiration and the current clinical scenario, by the spinal team whether there is a need for orthotic adjustment.[Time of diagnosis of dysphagia]

Secondary Outcome Measures

Name	Time	Method
Presence or absence of improvement of dysphagia and/or aspiration after orthosis adjustment.[After orthosis adjustment on videofluoroscopy.<br><br>If orthotic adjustment is required (within the fluoroscopy suite), a repeat videofluoroscopy will be performed immediately post adjustment.]