Outpatient Swallowing Therapy for Subjects With Neurological Illness

NCT04595643 | Completed

• 1 other identifier: 1-10-72-182-20
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Change in Penetration Aspiration Scale (PAS)

  Baseline and 14 days follow-up

• Change in The Yale Pharyngeal Residue Severity Rating Scale

  Baseline and 14 days follow-up

• Facio Oral Tract Therapy - Swallowing assessment of Saliva (FOTT-SAS)

  Baseline, immediately after the intervention, and 14 days follow-up

• Dysphagia Handicap Index (DHI)

  Baseline, immediately after the intervention, and 14 days follow-up

Study Arms (1)

Specialized dysphagia treatment

EXPERIMENTAL

Dysphagia treatment is provided by occupational therapists specialized in dysphagia.

Other: Combination of different dysphagia training modalities

Interventions

Combination of different dysphagia training modalities OTHER

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

Specialized dysphagia treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Hammel Neurorehabilitation Centre and University Research Clinic

Hammel, Region of Central Jutland, 8450, Denmark

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jesper Fabricius, PhD

  Hammel Neurorehabilitation Centre and Univeristy Research Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: October 20, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 22, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)