Outpatient Swallowing Therapy for Subjects With Neurological Illness

Not Applicable

Completed

• Conditions: Dysphagia
• Interventions: Other: Combination of different dysphagia training modalities

• Registration Number: NCT04595643
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-18
• Study Start: 2020-10-01
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-20
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Specialized dysphagia treatment	Combination of different dysphagia training modalities	Dysphagia treatment is provided by occupational therapists specialized in dysphagia.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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).

Trial Locations

Locations (1)

Hammel Neurorehabilitation Centre and University Research Clinic; 🇩🇰 Hammel, Region Of Central Jutland, Denmark