Outpatient Swallowing Therapy for Subjects With Neurological Illness

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04595643
• Other study ID #: 1-10-72-182-20
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Neurological illness

• Living in the Region of central Jutland

• FEDSS score 2-6

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Other:
• Combination of different dysphagia training modalities
Neuromuscular electrical stimulation, Masako exercises, Mendelsohn maneuver, chin down, mobilization, shaker exercises, eating different food consistencies.

Locations

Country	Name	City	State
Denmark	Hammel Neurorehabilitation Centre and University Research Clinic	Hammel	Region Of Central Jutland

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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