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

Stroke Clinical Trial

— DESIRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02960737
• Other study ID #: 2015-319-31M
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 2027

Study information

• Verified date: August 2023
• Source: Umeå University
• Contact: Patricia Hägglund, PhD/SLP
• Phone: +46907850000
• Email: patricia.hagglund[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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, Skaraborg hospital (Skövde), Helsingborg hospital, Halland hospital, Kungälv 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Persistent dysphagia 12(±3) weeks after first time 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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Sweden	University Hospital of Umeå	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	University Hospital, Umeå

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Death	Change in rate of death	At start, at end of treatment (after 3 months) and 6 months post-intervention