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

Not Applicable

Recruiting

• Conditions: Dysphagia; Stroke
• Interventions: Device: Oral neuromuscular training using an oral device

• Registration Number: NCT02960737
• Lead Sponsor: Umeå University

Brief 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.

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 Timeline

• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-11-07
• Study First Posted: 2016-11-10
• Study Start: 2022-12-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Oral neuromuscular training using an oral device	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Umeå; 🇸🇪 Umeå, Sweden