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Oral Screens in Post Stroke Training

NCT03167892 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-04-18

No results posted yet for this study

Summary

Stroke is a common disease in older people, and often leads to various degrees of disability. Dysphagia is one such consequence which is associated with aspiration pneumonia and malnutrition. There are studies showing that oral screen-training may reduce dysphagia, but the method is insufficiently evaluated. Since treatment with an oral screen is easy, relatively quick and cheap, it is of high relevance to perform a strict and unbiased study to assess the feasibility and efficacy of the intervention. Thus, the aim of the present study is to evaluate the effect of daily oral screen training in post-stroke patients with dysphagia.

A randomized controlled clinical study will be performed in subjects who have had a first stroke 8-12 months earlier and suffer from dysphagia. The intervention consists of daily oral screen training for 3 months. In total 70 subjects will be randomized to intervention or control. The changes in swallowing capacity is the main outcome, and secondary outcomes are subjective swallowing problems, lip force, chewing function and quality of life.

Improved oral motor function and decreased dysphagia in post-stroke patients will result in an improved quality of life for the individual, and also reduce hospitalization and health care costs.

Conditions

  • Dysphagia, Oropharyngeal

Interventions

DEVICE

Oral screen

Oral screen training three times per day with an effective training time of 1.5 minutes, for 3 mo

Sponsors & Collaborators

Principal Investigators

  • Gunilla Sandborgh-Englund, Prof · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03167892 on ClinicalTrials.gov