Clinical trial NCT04164420: Oral Neuromuscular Training in Stroke Patients With Dysphagia
Official title: Oral Neuromuscular Training in Stroke Patients With Dysphagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Dysphagia
Keywords: Stroke
Dysphagia
Treatment
Intervention
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2019-11-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups in parallel for five weeks. To either oral neuromuscular training and orofacial sensory-vibration stimulation or to only orofacial sensory-vibration stimulation.
Primary purpose: TREATMENT

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 %.

Eligibility criteria: 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.

Primary outcomes:
measure: Swallowing ability
timeFrame: Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up
Secondary outcomes:
measure: Lip-force (LF)
timeFrame: Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up
measure: Swallowing function
timeFrame: Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University
Study officials:
affiliation: Umeå University
name: Per Wester, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hagglund P, Hagg M, Levring Jaghagen E, Larsson B, Wester P. Oral neuromuscular training in patients with dysphagia after stroke: a prospective, randomized, open-label study with blinded evaluators. BMC Neurol. 2020 Nov 7;20(1):405. doi: 10.1186/s12883-020-01980-1.