Oral Neuromuscular Training in Stroke Patients With Dysphagia

NCT04164420 | Completed

• 1 other identifier: 2004:M-435
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Dysphagia

Keywords

Stroke; Dysphagia; Treatment; Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Lip-force (LF)

  Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up

• Swallowing function

  Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up

Study Arms (2)

Oral neuromuscular training and orofacial sensory-vibration

EXPERIMENTAL

Intensive training with oral neuromuscular training and orofacial sensory-vibration stimulation for 5 weeks. The oral neuromuscular training is performed three times per session, and three times daily before eating. Regarding the orofacial sensory-vibration stimulation, the instructions is given on how to stimulate the buccinator mechanism, lips, external floor, and the tongue three times daily before a meal by using a toothbrush.

Behavioral: Oral neuromuscular training and orofacial sensory-vibration

Orofacial sensory-vibration stimulation

ACTIVE COMPARATOR

Orofacial sensory-vibration stimulation by using an electrical toothbrush for five weeks. Instructions is given on how to stimulate the buccinator mechanism, lips, external floor, and the tongue three times daily before a meal.

Behavioral: Orofacial sensory-vibration stimulation

Interventions

Oral neuromuscular training and orofacial sensory-vibration BEHAVIORAL

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.

Oral neuromuscular training and orofacial sensory-vibration

Orofacial sensory-vibration stimulation BEHAVIORAL

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.

Orofacial sensory-vibration stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First-ever stroke and,
• Pathological timed water swallow test (TWST) at four to five weeks after stroke onset.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead
• Uppsala University: collaborator

Study Sites (1)

Umeå University

Umeå, Sweden

Location

Related Publications (1)

• 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.

  PMID: 33158423 DERIVED

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Per Wester, Professor

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 15, 2019
• Study Start: December 1, 2006
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: February 25, 2020

Record last verified: 2019-09

Locations

SE (1)