NCT03167892

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

September 15, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

3.8 years

First QC Date

May 11, 2017

Last Update Submit

April 11, 2022

Conditions

Dysphagia, Oropharyngeal

Outcome Measures

Primary Outcomes (1)

  • SCT

    Swallowing capacity test

    Change from baseline swallowing capacity baseline at 3 mo

Secondary Outcomes (5)

  • Lip force

    Change from baseline lip force at Month 3

  • Chewing function

    Change from baseline bolus formation at Month 3

  • QoL

    Change from baseline ESAS at Month 3

  • Chewing function

    Change from baseline mixing efficiency at Month 3

  • QoL

    Change from baseline LiSat at Month 3

Study Arms (2)

Intervention

EXPERIMENTAL

Oral screen

Device: Oral screen

Control

NO INTERVENTION

No intervention

Interventions

Oral screenDEVICE

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

Intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First or second stroke 8-12 months earlier.
  • Remaining subjective and objective swallowing difficulties.
  • Can eat. Can perform the training by himself/herself or with assistance from someone.
  • Natural teeth corresponding category A according to Eichner's index

You may not qualify if:

  • Moderate to severe impressive aphasia: \<4.0 points by A-ning
  • Moderate to severe cognitive impairment: \<23 by MoCA
  • Unilateral neglect according to baking tray task

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Dental Service in Stockholm

Stockholm, SE11219, Sweden

Location

Related Publications (10)

  • Appelros P, Karlsson GM, Thorwalls A, Tham K, Nydevik I. Unilateral neglect: further validation of the baking tray task. J Rehabil Med. 2004 Nov;36(6):258-61. doi: 10.1080/16501970410029852.

    PMID: 15841602BACKGROUND

  • Bakke M, Bergendal B, McAllister A, Sjogreen L, Asten P. Development and evaluation of a comprehensive screening for orofacial dysfunction. Swed Dent J. 2007;31(2):75-84.

    PMID: 17695052BACKGROUND

  • Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991 Summer;7(2):6-9.

    PMID: 1714502BACKGROUND

  • Fugl-Meyer AR, Melin R, Fugl-Meyer KS. Life satisfaction in 18- to 64-year-old Swedes: in relation to gender, age, partner and immigrant status. J Rehabil Med. 2002 Sep;34(5):239-46. doi: 10.1080/165019702760279242.

    PMID: 12392240BACKGROUND

  • Hagg M, Tibbling L. Effect of oral IQoro R and palatal plate training in post-stroke, four-quadrant facial dysfunction and dysphagia: A comparison study. Acta Otolaryngol. 2015 Sep;135(9):962-8. doi: 10.3109/00016489.2015.1042043. Epub 2015 May 7.

    PMID: 25947252BACKGROUND

  • Moller R, Safa S, Ostberg P. Validation of the Swedish translation of eating assessment tool (S-EAT-10). Acta Otolaryngol. 2016 Jul;136(7):749-53. doi: 10.3109/00016489.2016.1146411. Epub 2016 Feb 29.

    PMID: 26924383BACKGROUND

  • Hagg M, Tibbling L. Four-quadrant facial function in dysphagic patients after stroke and in healthy controls. Neurol Res Int. 2014;2014:672685. doi: 10.1155/2014/672685. Epub 2014 Mar 4.

    PMID: 24724023BACKGROUND

  • Schimmel M, Christou P, Miyazaki H, Halazonetis D, Herrmann FR, Muller F. A novel colourimetric technique to assess chewing function using two-coloured specimens: Validation and application. J Dent. 2015 Aug;43(8):955-64. doi: 10.1016/j.jdent.2015.06.003. Epub 2015 Jun 22.

    PMID: 26111925BACKGROUND

  • Nathadwarawala KM, Nicklin J, Wiles CM. A timed test of swallowing capacity for neurological patients. J Neurol Neurosurg Psychiatry. 1992 Sep;55(9):822-5. doi: 10.1136/jnnp.55.9.822.

    PMID: 1402974BACKGROUND

  • Dalum J, Skott P, Akesson E, Persson E, Karlsson A, Habel H, Seiger A, McAllister A, Johansson K, Sandborgh-Englund G. Effect of Oral Screen Training After Stroke-A Randomised Controlled Trial. Gerodontology. 2025 Sep;42(3):380-385. doi: 10.1111/ger.12803. Epub 2024 Dec 5.

    PMID: 39636679DERIVED

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Early Detection of Cancer

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Early DiagnosisDiagnosis

Study Officials

  • Gunilla Sandborgh-Englund, Prof

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 30, 2017

Study Start

September 15, 2017

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

April 18, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)