Dysphagia After Different Swallowing Therapies

Completed

Phase N/A Results N/A

Trial Description

Dysphagia after stroke is associated to increased pulmonary complications and mortality. The swallowing therapies could decrease the pulmonary complications and improve the quality of life after stroke. The swallowing therapies include dietary modifications, thermal stimulation, compensatory positions, and oropharyngeal muscle stimulation. Most researchers used clinical assessments and videofluoroscopy to evaluate the effect of the swallowing therapies. Some authors performed functional magnetic resonance imaging (fMRI) to investigate the brain neuroactivity during swallowing with tasks in normal adults and unilateral hemispheric stroke patients. The aim of this study is to explore the effect of swallowing therapies not only in clinical swallowing function but also brain plasticity of acute stroke patients with dysphagia by videofluoroscopy and fMRI.

Detailed Description

In the study, 10 healthy controls and 48 patients with a single and acute hemispheric or brain stem stroke will be enrolled. Both 24 hemispheric and 24 brain stem stroke patients will be divided into 3 groups. General swallowing therapy, oropharyngeal neuromuscular electrical stimulation (NMES), and combined general and NMES therapies will be randomly provided for the 3 groups. Each patient will receive clinical assessment of food oral intake scale, functional dysphagia scale of videofluoroscopy, and brain neuroactivity in fMRI.
The investigators hope to find the benefit of the swallowing therapies both in clinical swallowing function and in brain functional neuroactivity/reorganization after acute stroke. While comparing the 3 swallowing therapies, different functional neuroactivity may be facilitated by different swallowing therapies. Finally, the investigators could also find out the most effective swallowing therapy among the 3 therapies in acute stroke patients with dysphagia according to the findings of videofluoroscopy and fMRI.

Conditions

Interventions

  • General swallowing therapy Other
    Intervention Desc: including a session of oral exercises, tactile stimulation, compensatory techniques, swallowing maneuvers that are taught to the participants by a speech therapist.
    ARM 1: Kind: Experimental
    Label: general swallowing therapy
    Description: including: oral exercises tactile stimulation compensatory techniques swallowing maneuvers
    ARM 2: Kind: Experimental
    Label: : the combined NMES and general swallowing therapies
  • NMES therapy Other
    Intervention Desc: he NMES therapy with VitalStim therapeutic device will be done by one physician who is licensed practitioner and certified in use of the VitalStim device. The placement of 2-channel electrodes is depended on the dysphagic types and the findings on VFS.
    ARM 1: Kind: Experimental
    Label: the NMES therapy with VitalStim therapeutic device
    Description: The placement of 2-channel electrodes is depended on the dysphagic types and the findings on VFS
    ARM 2: Kind: Experimental
    Label: : the combined NMES and general swallowing therapies

Outcomes

Type Measure Time Frame Safety Issue
Primary The functional oral intake scale baseline (before intervention), changes from baseline FOIS at 4 weeks
Secondary 8-point penetration-aspiration scale (PAS) baseline (before intervention), changes from baseline PAS score at 4 weeks
Secondary 11-item functional dysphagia scale (FDS) baseline (before intervention), changes from baseline FDS score at 4weeks
Secondary 3-Dimensional (3D) structural MRI baseline (before intervention), changes from baseline result of 3-Dimensional (3D) structural MRI at 4 weeks
Secondary Function MRI baseline (before intervention), changes from baseline result of fMRI at 4 weeks
Secondary Diffusion tensor imaging baseline (before intervention), changes from baseline result of diffusion tensor imaging at 4 weeks

Sponsors