Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Outpatient Swallowing Therapy for Subjects With Neurological Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04595643
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

Health care staff in the municipalities do not always have the necessary competencies to treat patients with dysphagia. At the present neurorehabilitation hospital dysphagia examinations for outpatients are provided.

The objective is to investigate the effect of a specialized outpatient dysphagia unit for subjects with dysphagia following neurological illness. Occupational therapists from the outpatient dysphagia unit will train with subjects for 2-3 weeks, and supervise furter training provided by health care staff in the municipalities.


Condition or disease Intervention/treatment Phase
Dysphagia Other: Combination of different dysphagia training modalities Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outpatient Swallowing Therapy for Subjects With Neurological Illness - a Feasability Study
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Specialized dysphagia treatment
Dysphagia treatment is provided by occupational therapists specialized in dysphagia.
Other: Combination of different dysphagia training modalities
Neuromuscular electrical stimulation, Masako exercises, Mendelsohn maneuver, chin down, mobilization, shaker exercises, eating different food consistencies.




Primary Outcome Measures :
  1. Change in Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) [ Time Frame: Baseline and 14 days follow-up ]
    The FEDSS assess severity of dysphagia, with scores ranging 1-6. Higher scores mean worse outcome.

  2. Change in Functional Oral Intake Scale (FOIS) [ Time Frame: Baseline, immediately after the intervention, and 14 days follow-up ]
    Level of oral intake with scores ranging 1-7. Higher scores mean better outcome.


Secondary Outcome Measures :
  1. Change in Penetration Aspiration Scale (PAS) [ Time Frame: Baseline and 14 days follow-up ]
    Assessment of aspiration with scores ranging 1-8. Higher scores mean worse outcome.

  2. Change in The Yale Pharyngeal Residue Severity Rating Scale [ Time Frame: Baseline and 14 days follow-up ]
    Assessment of residue location and amount of residue. Two subscales with scores ranging 1-5. Higher scores mean worse outcome.

  3. Facio Oral Tract Therapy - Swallowing assessment of Saliva (FOTT-SAS) [ Time Frame: Baseline, immediately after the intervention, and 14 days follow-up ]
    Clinical examination of swallowing function. Yes or no to initiation of oral intake (binary outcome).

  4. Dysphagia Handicap Index (DHI) [ Time Frame: Baseline, immediately after the intervention, and 14 days follow-up ]
    Questionnaire on experience of dysphagia. 25 items with a toal score ranging 0-100. Higher scores mean worse outcome. Also measures overall severity with scores ranging 1-7. Higher scores means worse outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neurological illness
  • Living in the Region of central Jutland
  • FEDSS score 2-6

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04595643


Contacts
Layout table for location contacts
Contact: Jesper Fabricius, PhD +4578419051 Jesper.Fabricius@rm.dk

Locations
Layout table for location information
Denmark
Hammel Neurorehabilitation Centre and University Research Clinic Recruiting
Hammel, Region Of Central Jutland, Denmark, 8450
Contact: Jesper Fabricius, PhD         
Sponsors and Collaborators
University of Aarhus
Investigators
Layout table for investigator information
Principal Investigator: Jesper Fabricius, PhD Hammel Neurorehabilitation Centre and Univeristy Research Clinic
Layout table for additonal information
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04595643    
Other Study ID Numbers: 1-10-72-182-20
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases