Stroke Clinical Trial
Official title:
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.
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 %.
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