Dysphagia After Different Swallowing Therapies

Not Applicable

Completed

• Conditions: Dysphagia; Stroke; Videofluoroscopy
• Interventions: Other: general swallowing therapy; Other: NMES therapy

• Registration Number: NCT03048916
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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.

Study Timeline

• Study Start: 2010-08-01
• Primary Completion: 2012-07-31
• Study Completion: 2013-07-31
• Status Verified: 2017-02
• Study First Submitted: 2017-02-05
• Study First Submitted QC: 2017-02-08
• Last Update Submitted: 2017-02-08
• Study First Posted: 2017-02-09
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
: the combined NMES and general swallowing therapies	general swallowing therapy	-
general swallowing therapy	general swallowing therapy	including: * oral exercises * tactile stimulation * compensatory techniques * swallowing maneuvers
the NMES therapy with VitalStim therapeutic device	NMES therapy	The placement of 2-channel electrodes is depended on the dysphagic types and the findings on VFS
: the combined NMES and general swallowing therapies	NMES therapy	-

Primary Outcome Measures

Name	Time	Method
The functional oral intake scale	baseline (before intervention), changes from baseline FOIS at 4 weeks	Clinical swallowing evaluations: The functional oral intake scale (FOIS) was reported by Crary et al. for presenting the functional oral intake of food and liquid in stroke patients. One physician who is blinded to the therapies will evaluate the FOIS for each participant before and after swallowing treatments.

Secondary Outcome Measures

Name	Time	Method
8-point penetration-aspiration scale (PAS)	baseline (before intervention), changes from baseline PAS score at 4 weeks	VFS is a standard tool for swallowing disorders. A 8-point penetration-aspiration scale (PAS) is used for observing the event of penetration or aspiration on VFS.
11-item functional dysphagia scale (FDS)	baseline (before intervention), changes from baseline FDS score at 4weeks	A 11-item functional dysphagia scale (FDS) of VFS is a sensitive and specific method for quantifying swallowing function in stroke.
3-Dimensional (3D) structural MRI	baseline (before intervention), changes from baseline result of 3-Dimensional (3D) structural MRI at 4 weeks	MR images are obtained using a 3.0-T whole body magnet with a 50- and 23-mT/m gradient strength, and an echo-planar-capable receiver (GE SIGNA EXCITE HD, GE Medical Systems, Milwaukee, US).; A 3-dimensional (3D) structural MRI is acquired for each subject using a T1-weighted gradient echo magnetization prepared rapid gradient echo sequence yielding 124 sagittal slices with a defined voxel size of 1 x 1 x 1.5 mm.
Function MRI	baseline (before intervention), changes from baseline result of fMRI at 4 weeks	MR images are obtained using a 3.0-T whole body magnet with a 50- and 23-mT/m gradient strength, and an echo-planar-capable receiver (GE SIGNA EXCITE HD, GE Medical Systems, Milwaukee, US).; The functional images are obtained using an EPI sequence with the following parameters: 33 axial slices, image resolution = 3.75\*3.75\*4, and TR= 2000 ms.
Diffusion tensor imaging	baseline (before intervention), changes from baseline result of diffusion tensor imaging at 4 weeks	MR images are obtained using a 3.0-T whole body magnet with a 50- and 23-mT/m gradient strength, and an echo-planar-capable receiver (GE SIGNA EXCITE HD, GE Medical Systems, Milwaukee, US).; An 8 channels diffusion tensor imaging (DTI) acquisition protocol will be used to acquire high resolution DTI, i.e. 2 x 2 x 2 mm3 voxel size. With 13 diffusion encoding directions and number of average of 4, whole brain DTI and high resolution eigenvector field can be acquired within 20 mins.