Stroke Clinical Trial - Dysphagia Evaluation After Stroke- Effect Oral

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This study aims to investigate the effect of oral neuromuscular training in stroke patients with persistent oral- and pharyngeal dysphagia 12 (±3) weeks after stroke onset. Interventional study with PROBE-design (prospective randomized open-label blinded evaluator). Consecutive patients with first-ever stroke without previously known dysphagia with persistent dysphagia (DOSS<6) at 3 months (12±3 weeks) post-stroke onset. Patients are eligible to participate if they are admitted to one of the following seven hospitals/centers in Sweden: Umeå University hospital, Danderyds hospital, Skaraborg hospital (Skövde), Helsingborg hospital, Halland hospital, Kungälv hospital and Ellenbogen in Malmö. Further centers will be recruited. Exclusion criteria: Unable/unwilling to give informed consent or to cooperate. Randomization will be made web-based 1:1 by use of the developed REDCap system with stratification for center and aspiration (yes/no). In total, 336 stroke patients (168 intervention group; 168 control group) with persistent dysphagia 12(±3) weeks after stroke onset will be included in the present study. The intervention group will be offered to undergo oral neuromuscular training alongside routine care with compensatory training for 3 months. The control group will only be offered routine care with compensatory training for 3 months. The participants' status regarding swallowing function, nutritional status, quality of life related to swallowing, pneumonia, functional status including lip force, and death will be assessed before and after the completed intervention period, and 6 months post-intervention. The primary endpoint will be analyzed using an ordinal regression (proportional odds) model, adjusting for baseline DOSS as well as for the stratifying variables center and aspiration. The investigators hypothesize that swallowing intervention with oral neuromuscular training is more effective than routine care rehabilitation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02960737
Study type	Interventional
Source	Umeå University
Contact	Patricia Hägglund, PhD/SLP
Phone	+46907850000
Email	patricia.hagglund@umu.se
Status	Recruiting
Phase	N/A
Start date	December 1, 2022
Completion date	December 2027

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms