Outpatient Swallowing Therapy for Subjects With Neurological Illness

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT04595643

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dysphagia	Other: Combination of different dysphagia training modalities	N/A

Study Design

Study Type:

Interventional

Actual 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 :

Oct 1, 2020

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) [Baseline and 14 days follow-up]
The FEDSS assess severity of dysphagia, with scores ranging 1-6. Higher scores mean worse outcome.
Change in Functional Oral Intake Scale (FOIS) [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

Change in Penetration Aspiration Scale (PAS) [Baseline and 14 days follow-up]
Assessment of aspiration with scores ranging 1-8. Higher scores mean worse outcome.
Change in The Yale Pharyngeal Residue Severity Rating Scale [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.
Facio Oral Tract Therapy - Swallowing assessment of Saliva (FOTT-SAS) [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).
Dysphagia Handicap Index (DHI) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hammel Neurorehabilitation Centre and University Research Clinic	Hammel	Region Of Central Jutland	Denmark	8450

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator: Jesper Fabricius, PhD, Hammel Neurorehabilitation Centre and Univeristy Research Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT04595643

Other Study ID Numbers:

1-10-72-182-20

First Posted:

Oct 20, 2020

Last Update Posted:

Jan 22, 2021

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Deglutition Disorders

Study Results

No Results Posted as of Jan 22, 2021