Clinical trial NCT02960737: Dysphagia Evaluation After Stroke- Effect Oral Neuromuscular Training on Swallowing Dysfunction
Official title: Dysphagia Evaluation After Stroke - a Randomized Controlled Trial of Oral Neuromuscular Training on Swallowing Dysfunction (DESIRE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphagia
Stroke
Keywords: Dysphagia
Stroke
Intervention
Oral neuromuscular training
Randomized control trial
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: University Hospital, Umeå
First posted: 2016-11-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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, Södersjukhuset, Skaraborg Hospital (Skövde), Helsingborg Hospital, Halland Hospital, Kungälv Hospital, Kalix Hospital, Skellefteå 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Swallowing Function
timeFrame: At start compared with at end of treatment (after 3 months)
Secondary outcomes:
measure: Swallowing function
timeFrame: At start and 6 months post-intervention
measure: Lip-force (LF)
timeFrame: At start, at end of treatment (after 3 months) and 6 months post-intervention
measure: Swallowing Quality of Life Questionnaire (SWAL-QOL)
timeFrame: At start, at end of treatment (after 3 months) and 6 months post-intervention
measure: Nutritional status
timeFrame: At start, at end of treatment (after 3 months) and 6 months post-intervention
measure: Activity of daily living (ADL)
timeFrame: At start, at end of treatment (after 3 months) and 12-18 months post-intervention
measure: Global disability
timeFrame: At start, at end of treatment (after 3 months) and 6 months post-intervention
measure: Aspiration-pneumonia
timeFrame: At start, at end of treatment (after 3 months) and 6 months post-intervention
measure: Death
timeFrame: At start, at end of treatment (after 3 months) and 6 months post-intervention
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: University Hospital of Umeå
Study officials:
affiliation: Umeå University
name: Patricia Hägglund, PhD/SLP
role: PRINCIPAL_INVESTIGATOR
References: