Oral Neuromuscular Training in Stroke Patients With Dysphagia

Stroke Clinical Trial

Official title:

Oral Neuromuscular Training in Stroke Patients With Dysphagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04164420
• Other study ID #: 2004:M-435
• Status: Completed
• Phase: N/A
• Start date: December 2006
• Est. completion date: January 2020

Study information

• Verified date: September 2019
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 %.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Stroke

Intervention

Behavioral:
• Oral neuromuscular training and orofacial sensory-vibration
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
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.

Locations

Country	Name	City	State
Sweden	Umeå University	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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