Outpatient Swallowing Therapy for Subjects With Neurological Illness

Outpatient Swallowing Therapy for Subjects With Neurological Illness - a Feasability Study

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.

Study Overview

• Status: Completed
• Conditions: Dysphagia
• Intervention / Treatment: Other: Combination of different dysphagia training modalities

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Region Of Central Jutland
    • Hammel, Region Of Central Jutland, Denmark, 8450
      • Hammel Neurorehabilitation Centre and University Research Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS)	The FEDSS assess severity of dysphagia, with scores ranging 1-6. Higher scores mean worse outcome.	Baseline and 14 days follow-up
Change in Functional Oral Intake Scale (FOIS)	Level of oral intake with scores ranging 1-7. Higher scores mean better outcome.	Baseline, immediately after the intervention, and 14 days follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Penetration Aspiration Scale (PAS)	Assessment of aspiration with scores ranging 1-8. Higher scores mean worse outcome.	Baseline and 14 days follow-up
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.	Baseline and 14 days follow-up
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).	Baseline, immediately after the intervention, and 14 days follow-up
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.	Baseline, immediately after the intervention, and 14 days follow-up

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Jesper Fabricius, PhD, Hammel Neurorehabilitation Centre and Univeristy Research Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 1-10-72-182-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No