Outpatient Swallowing Therapy for Subjects With Neurological Illness
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|ClinicalTrials.gov Identifier: NCT04595643|
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : November 25, 2020
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Outpatient Swallowing Therapy for Subjects With Neurological Illness - a Feasability Study|
|Actual Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
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.
- Change in Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) [ Time Frame: 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) [ Time Frame: 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 Penetration Aspiration Scale (PAS) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04595643
|Contact: Jesper Fabricius, PhD||+4578419051||Jesper.Fabricius@rm.dk|
|Hammel Neurorehabilitation Centre and University Research Clinic||Recruiting|
|Hammel, Region Of Central Jutland, Denmark, 8450|
|Contact: Jesper Fabricius, PhD|
|Principal Investigator:||Jesper Fabricius, PhD||Hammel Neurorehabilitation Centre and Univeristy Research Clinic|