Oral Neuromuscular Training in Stroke Patients With Dysphagia

Not Applicable

Completed

• Conditions: Dysphagia; Stroke

• Registration Number: NCT04164420
• Lead Sponsor: Umeå University

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 %.

Study Timeline

• Study Start: 2006-12
• Status Verified: 2019-09
• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-12
• Study First Posted: 2019-11-15
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Swallowing ability	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 Outcome Measures

Name	Time	Method
Lip-force (LF)	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.
Swallowing function	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)

Trial Locations

Locations (1)

Umeå University; 🇸🇪 Umeå, Sweden