Outpatient Swallowing Therapy for Subjects With Neurological Illness

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04595643

Enrollment

Registered

2020-10-20

Start date

2020-10-01

Completion date

2020-12-31

Last updated

2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia

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.

Interventions

OTHERCombination of different dysphagia training modalities

Neuromuscular electrical stimulation, Masako exercises, Mendelsohn maneuver, chin down, mobilization, shaker exercises, eating different food consistencies.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026