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Completed

NCT Number: NCT04164420

Oral Neuromuscular Training in Stroke Patients With Dysphagia

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umeå University

Umeå, Sweden

About this study

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 %.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral neuromuscular training and orofacial sensory-vibration

Behavioral

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.

Orofacial sensory-vibration stimulation

Behavioral

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.

Primary outcomes

  1. Swallowing ability

    Time frame: Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up

    Change in swallowing function measured by the timed water swallow test

Secondary outcomes

  1. Lip-force (LF)

    Time frame: Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up

    Change in lip-force measured in newtons (N) with the Lip Force Meter LF100.

  2. Swallowing function

    Time frame: Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up

    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)

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Uppsala University

Registry information

Important dates

Study start
2006
Primary completion
2020
Study completion
2020
First posted
Nov 15, 2019
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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