Stroke Clinical Trial
Official title:
Oral Neuromuscular Training in Stroke Patients With Dysphagia
NCT number | NCT04164420 |
Other study ID # | 2004:M-435 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2006 |
Est. completion date | January 2020 |
Verified date | September 2019 |
Source | Umeå University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Umeå University | Umeå |
Lead Sponsor | Collaborator |
---|---|
Umeå University | Uppsala University |
Sweden,
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 |
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