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Completed

NCT Number: NCT04595643

Outpatient Swallowing Therapy for Subjects With Neurological Illness

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hammel Neurorehabilitation Centre and University Research Clinic

Hammel, Region of Central Jutland, 8450, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Combination of different dysphagia training modalities

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 20, 2020
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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