Dysphagia Evaluation After Stroke- Effect Oral Neuromuscular Training on Swallowing Dysfunction

NCT02960737 | Recruiting

• 1 other identifier: 2015-319-31M
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effect of a specific rehabilitation program with an oral device used in stroke patients with persistent oral-and pharyngeal dysphagia.

Conditions

Dysphagia; Stroke

Keywords

Dysphagia; Stroke; Intervention; Oral neuromuscular training; Randomized control trial

Outcome Measures

Primary Outcomes (1)

• Swallowing Function

  Change in swallowing function measured by the Dysphagia Outcome Severity Scale (DOSS) using Fiberoptic endoscopic evaluation of swallowing (FEES)

  At start compared with at end of treatment (after 3 months)

Secondary Outcomes (8)

• Swallowing function

  At start and 6 months post-intervention

• Lip-force (LF)

  At start, at end of treatment (after 3 months) and 6 months post-intervention

• Swallowing Quality of Life Questionnaire (SWAL-QOL)

  At start, at end of treatment (after 3 months) and 6 months post-intervention

• Nutritional status

  At start, at end of treatment (after 3 months) and 6 months post-intervention

• Activity of daily living (ADL)

  At start, at end of treatment (after 3 months) and 12-18 months post-intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Intensive training with oral neuromuscular training using an oral device (intervention group) and routine care with compensatory swallowing training under 3 months with start 12 (±3) weeks after stroke onset.

Device: Oral neuromuscular training using an oral device

Control group

NO INTERVENTION

Routine care with compensatory swallowing training under 3 months with starting 12 (±3) weeks after stroke onset.

Interventions

Oral neuromuscular training using an oral device DEVICE

The oral device is used for 30 seconds, three times a day, before meals and implies new possibilities for training of the orofacial and pharyngeal muscles.

Intervention group

Eligibility Criteria

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

You may qualify if:

• Persistent dysphagia 12(±3) weeks after STROKE.

You may not qualify if:

• Stroke patients with neurologic or psychiatric disorders or other diseases/conditions that can affect swallowing function.
• Unable to collaborate due to other serious diseases and/or to affected general condition.

Sponsors & Collaborators

• Umeå University: lead
• University Hospital, Umeå: collaborator

Study Sites (1)

University Hospital of Umeå

Umeå, Sweden

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Patricia Hägglund, PhD/SLP

  Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Hägglund, PhD/SLP

CONTACT

+46907850000; patricia.hagglund@umu.se

Per Wester, Professor

CONTACT

+46907850000; per.wester@umu.se

Study Design

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

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: November 10, 2016
• Study Start: December 1, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)