Health TrialsbyHealthPanel

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

ConditionsDysphagiaStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUmeå University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Persistent dysphagia 12(±3) weeks after STROKE.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Swallowing Function

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

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

Secondary outcomes

1

Swallowing function

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

Time frame
At start and 6 months post-intervention
2

Lip-force (LF)

Change in lip-force measured in newtons (N) with the Lip Force Meter LF100.

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

Swallowing Quality of Life Questionnaire (SWAL-QOL)

Change in quality of life related to swallowing measured by the SWAL-QOL questionnaire.

Time frame
At start, at end of treatment (after 3 months) and 6 months post-intervention
4

Nutritional status

Change in nutritional status measured with the Mini Nutritional Assessment (MNA).

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Umeå University

Lead sponsor

University Hospital, Umeå

Collaborator

Source ClinicalTrials.gov
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