Oral Neuromuscular Training in Stroke Patients With Dysphagia

Study Overview
=================
Brief Summary
-----------------
This study aims to explore if oral neuromuscular training is superior to orofacial sensory-vibration stimulation in patients with oropharyngeal dysphagia. Four weeks after stroke onset, patients with oropharyngeal dysphagia and pathological swallowing according to the timed water swallow test (TWST) will be randomized 1:1 into a 5-week oral neuromuscular training with an oral device in addition to orofacial sensory-vibration stimulation with an electrical toothbrush (intervention group) or orofacial sensory-vibration stimulation only (control group). The participants will be examined with a TWST, lip force test, and videofluoroscopy (VFS) of oropharyngeal swallowing before (baseline), after 5-weeks training (end-of-training) and at a 12-18 months follow-up. The primary endpoint is changes in TWST at the end-of-training compared with baseline, and at late follow-up based on intention-to-treat analyses. The secondary endpoints are the corresponding changes in lip force and aspiration frequency at VFS.

Detailed Description
-----------------
This study aims to explore if oral neuromuscular training is superior to orofacial sensory-vibration stimulation in patients with oropharyngeal dysphagia. Study design: This 2-center study is an intension-to-treat prospective randomized open-label trial with blinded evaluators (PROBE) design. Evaluations are made at baseline, at end of training, and at late follow-up after a period without training to investigate if any lasting positive training effect was present. Inclusion criteria: First-ever stroke and a pathological timed water swallow test (TWST) at four to five weeks after stroke onset. Exclusion criteria: Inability to cooperate, percutaneous endoscopic gastrostomy (PEG), neurological diseases other than stroke, known history of dysphagia, prominent horizontal overbite, hypersensitivity to the acrylate in the oral device. Study procedure: Four weeks after stroke onset, patients with oropharyngeal dysphagia and pathological swallowing according to the timed water swallow test (TWST) will be randomized 1:1 into a 5-week oral neuromuscular training with an oral device in addition to orofacial sensory-vibration stimulation with an electrical toothbrush (intervention group) or orofacial sensory-vibration stimulation only (control group). The participants will be examined with a TWST, lip force test, and videofluoroscopy (VFS) of oropharyngeal swallowing before (baseline), after 5-weeks training (end-of-training) and at a 12-18 months follow-up. The primary endpoint is changes in TWST at the end-of-training compared with baseline, and at late follow-up based on intention-to-treat analyses. The secondary endpoints are the corresponding changes in lip force and aspiration frequency at VFS. Sample size: In order to detect a critical change with a power of 80 %, a sample size of 44 patients (22 in the intervention group and 22 in the control group) that fulfilled the study protocol was required for a type I error of 5 %.

Official Title
-----------------
Oral Neuromuscular Training in Stroke Patients With Dysphagia

Conditions
-----------------
Stroke, Dysphagia

Intervention / Treatment
-----------------
* Behavioral: Oral neuromuscular training and orofacial sensory-vibration
* Behavioral: Orofacial sensory-vibration stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First-ever stroke and, Pathological timed water swallow test (TWST) at four to five weeks after stroke onset. Exclusion Criteria: Inability to cooperate Percutaneous endoscopic gastrostomy (PEG) Neurological diseases other than stroke Known history of dysphagia Prominent horizontal overbite Hypersensitivity to the acrylate in the oral device.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to one of two groups in parallel for five weeks. To either oral neuromuscular training and orofacial sensory-vibration stimulation or to only orofacial sensory-vibration stimulation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral neuromuscular training and orofacial sensory-vibration<br>Intensive training with oral neuromuscular training and orofacial sensory-vibration stimulation for 5 weeks. The oral neuromuscular training is performed three times per session, and three times daily before eating. Regarding the orofacial sensory-vibration stimulation, the instructions is given on how to stimulate the buccinator mechanism, lips, external floor, and the tongue three times daily before a meal by using a toothbrush. | Behavioral: Oral neuromuscular training and orofacial sensory-vibration<br>* Oral neuromuscular training is performed by using an oral device. The device is placed pre-dentally behind closed lips, and the participant is sitting in an up-right position. The participant is the instructed to hold the device against a gradually-increasing horizontal pulling force for 5-10 s, whilst trying to resist the force by tightening the lips and pressing the head backward against a head rest.<br>|
| Active Comparator: Orofacial sensory-vibration stimulation<br>Orofacial sensory-vibration stimulation by using an electrical toothbrush for five weeks. Instructions is given on how to stimulate the buccinator mechanism, lips, external floor, and the tongue three times daily before a meal. | Behavioral: Orofacial sensory-vibration stimulation<br>* All participants in the control group is given orofacial sensory-vibration stimulation by using an electrical toothbrush. Instructions is given on how to stimulate the buccinator mechanism, lips, external floor, and the tongue three times daily before a meal.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swallowing ability | Change in swallowing function measured by the timed water swallow test | Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lip-force (LF) | Change in lip-force measured in newtons (N) with the Lip Force Meter LF100. | Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up | 
| Swallowing function | Change in structural and functional swallowing ability measured by Videofluoroscopy (VFS) by using the penetration-aspiration scale by Rosenbek. The scale ranges from 0 (normal swallowing function) to 8 (aspiration without sufficient coughing/clearance) | Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Dysphagia, Treatment, Intervention