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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04595643
Other study ID # 1-10-72-182-20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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: -

Study Design


Related Conditions & MeSH terms


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
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