Dysphagia Evaluation After Stroke- Effect Oral Neuromuscular Training on Swallowing Dysfunction (DESIRE)

Dysphagia Evaluation After Stroke - a Randomized Controlled Trial of Oral Neuromuscular Training on Swallowing Dysfunction (DESIRE)

The aim of this study is to investigate the effect of a specific rehabilitation program with an oral device used in stroke patients with persistent oral-and pharyngeal dysphagia.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Dysphagia
• Intervention / Treatment: Device: Oral neuromuscular training using an oral device

Detailed Description

This study aims to investigate the effect of oral neuromuscular training in stroke patients with persistent oral- and pharyngeal dysphagia 12 (±3) weeks after stroke onset.

Interventional study with PROBE-design (prospective randomized open-label blinded evaluator). Consecutive patients with first-ever stroke without previously known dysphagia with persistent dysphagia (DOSS<6) at 3 months (12±3 weeks) post-stroke onset. Patients are eligible to participate if they are admitted to one of the following seven hospitals/centers in Sweden: Umeå University Hospital, Danderyds Hospital, Södersjukhuset, Skaraborg Hospital (Skövde), Helsingborg Hospital, Halland Hospital, Kungälv Hospital, Kalix Hospital, Skellefteå Hospital, and Ellenbogen in Malmö. Further centers will be recruited. Exclusion criteria: Unable/unwilling to give informed consent or to cooperate.

Randomization will be made web-based 1:1 by use of the developed REDCap system with stratification for center and aspiration (yes/no).

In total, 336 stroke patients (168 intervention group; 168 control group) with persistent dysphagia 12(±3) weeks after stroke onset will be included in the present study. The intervention group will be offered to undergo oral neuromuscular training alongside routine care with compensatory training for 3 months. The control group will only be offered routine care with compensatory training for 3 months.

The participants' status regarding swallowing function, nutritional status, quality of life related to swallowing, pneumonia, functional status including lip force, and death will be assessed before and after the completed intervention period, and 6 months post-intervention.

The primary endpoint will be analyzed using an ordinal regression (proportional odds) model, adjusting for baseline DOSS as well as for the stratifying variables center and aspiration.

The investigators hypothesize that swallowing intervention with oral neuromuscular training is more effective than routine care rehabilitation.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Per Wester, Professor; Phone Number: +46907850000; Email: per.wester@umu.se
• Study Contact Backup: Name: Patricia Hägglund, PhD/SLP; Phone Number: +46907850000; Email: patricia.hagglund@umu.se

Study Locations

• Sweden
  • Umeå, Sweden
    • Recruiting
    • University Hospital of Umeå
    • Contact: Patricia Hägglund, PhD; Email: patricia.hagglund@umu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Persistent dysphagia 12(±3) weeks after STROKE.

Exclusion Criteria:

• Stroke patients with neurologic or psychiatric disorders or other diseases/conditions that can affect swallowing function.
• Unable to collaborate due to other serious diseases and/or to affected general condition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Intensive training with oral neuromuscular training using an oral device (intervention group) and routine care with compensatory swallowing training under 3 months with start 12 (±3) weeks after stroke onset.	Device: Oral neuromuscular training using an oral device; The oral device is used for 30 seconds, three times a day, before meals and implies new possibilities for training of the orofacial and pharyngeal muscles.
No Intervention: Control group; Routine care with compensatory swallowing training under 3 months with starting 12 (±3) weeks after stroke onset.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swallowing Function	Change in swallowing function measured by the Dysphagia Outcome Severity Scale (DOSS) using Fiberoptic endoscopic evaluation of swallowing (FEES)	At start compared with at end of treatment (after 3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity of daily living (ADL)	Change in activity of daily living (ADL) measured by Barthels Index (BI).	At start, at end of treatment (after 3 months) and 12-18 months post-intervention
Swallowing function	Change in swallowing function measured by the Dysphagia Outcome Severity Scale (DOSS) using Fiberoptic endoscopic evaluation of swallowing (FEES)	At start and 6 months post-intervention
Lip-force (LF)	Change in lip-force measured in newtons (N) with the Lip Force Meter LF100.	At start, at end of treatment (after 3 months) and 6 months post-intervention
Swallowing Quality of Life Questionnaire (SWAL-QOL)	Change in quality of life related to swallowing measured by the SWAL-QOL questionnaire.	At start, at end of treatment (after 3 months) and 6 months post-intervention
Nutritional status	Change in nutritional status measured with the Mini Nutritional Assessment (MNA).	At start, at end of treatment (after 3 months) and 6 months post-intervention
Global disability	Change in global disability measured with modified Rankin Scale (mRS)	At start, at end of treatment (after 3 months) and 6 months post-intervention
Aspiration-pneumonia	Change in rate of aspiration-pneumonia based on the modified criteria by Centers for Disease Control and Prevention (CDC) for stroke-associated pneumonia	At start, at end of treatment (after 3 months) and 6 months post-intervention
Death	Change in rate of death	At start, at end of treatment (after 3 months) and 6 months post-intervention

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: University Hospital, Umeå
• Investigators: Principal Investigator: Patricia Hägglund, PhD/SLP, Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: November 7, 2016
• First Posted (Estimated): November 10, 2016

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Dysphagia; Intervention; Randomized control trial; Oral neuromuscular training
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Stroke; Deglutition Disorders
• Other Study ID Numbers: 2015-319-31M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No