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Outpatient Swallowing Therapy for Subjects With Neurological Illness

Primary Purpose

Dysphagia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Combination of different dysphagia training modalities
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Hammel Neurorehabilitation Centre and University Research Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Specialized dysphagia treatment

Arm Description

Dysphagia treatment is provided by occupational therapists specialized in dysphagia.

Outcomes

Primary Outcome Measures

Change in Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS)
The FEDSS assess severity of dysphagia, with scores ranging 1-6. Higher scores mean worse outcome.
Change in Functional Oral Intake Scale (FOIS)
Level of oral intake with scores ranging 1-7. Higher scores mean better outcome.

Secondary Outcome Measures

Change in Penetration Aspiration Scale (PAS)
Assessment of aspiration with scores ranging 1-8. Higher scores mean worse outcome.
Change in The Yale Pharyngeal Residue Severity Rating Scale
Assessment of residue location and amount of residue. Two subscales with scores ranging 1-5. Higher scores mean worse outcome.
Facio Oral Tract Therapy - Swallowing assessment of Saliva (FOTT-SAS)
Clinical examination of swallowing function. Yes or no to initiation of oral intake (binary outcome).
Dysphagia Handicap Index (DHI)
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.

Full Information

First Posted
September 18, 2020
Last Updated
January 21, 2021
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT04595643
Brief Title
Outpatient Swallowing Therapy for Subjects With Neurological Illness
Official Title
Outpatient Swallowing Therapy for Subjects With Neurological Illness - a Feasability Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Specialized dysphagia treatment
Arm Type
Experimental
Arm Description
Dysphagia treatment is provided by occupational therapists specialized in dysphagia.
Intervention Type
Other
Intervention Name(s)
Combination of different dysphagia training modalities
Intervention Description
Neuromuscular electrical stimulation, Masako exercises, Mendelsohn maneuver, chin down, mobilization, shaker exercises, eating different food consistencies.
Primary Outcome Measure Information:
Title
Change in Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS)
Description
The FEDSS assess severity of dysphagia, with scores ranging 1-6. Higher scores mean worse outcome.
Time Frame
Baseline and 14 days follow-up
Title
Change in Functional Oral Intake Scale (FOIS)
Description
Level of oral intake with scores ranging 1-7. Higher scores mean better outcome.
Time Frame
Baseline, immediately after the intervention, and 14 days follow-up
Secondary Outcome Measure Information:
Title
Change in Penetration Aspiration Scale (PAS)
Description
Assessment of aspiration with scores ranging 1-8. Higher scores mean worse outcome.
Time Frame
Baseline and 14 days follow-up
Title
Change in The Yale Pharyngeal Residue Severity Rating Scale
Description
Assessment of residue location and amount of residue. Two subscales with scores ranging 1-5. Higher scores mean worse outcome.
Time Frame
Baseline and 14 days follow-up
Title
Facio Oral Tract Therapy - Swallowing assessment of Saliva (FOTT-SAS)
Description
Clinical examination of swallowing function. Yes or no to initiation of oral intake (binary outcome).
Time Frame
Baseline, immediately after the intervention, and 14 days follow-up
Title
Dysphagia Handicap Index (DHI)
Description
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.
Time Frame
Baseline, immediately after the intervention, and 14 days follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Neurological illness Living in the Region of central Jutland FEDSS score 2-6 Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper Fabricius, PhD
Organizational Affiliation
Hammel Neurorehabilitation Centre and Univeristy Research Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hammel Neurorehabilitation Centre and University Research Clinic
City
Hammel
State/Province
Region Of Central Jutland
ZIP/Postal Code
8450
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Outpatient Swallowing Therapy for Subjects With Neurological Illness

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