Dysphagia After Different Swallowing Therapies

NCT03048916 | Completed

• 1 other identifier: NMRPG896021
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dysphagia; Videofluoroscopy; Stroke

Keywords

dysphagia; stroke; magnetic resonance imaging; videofluoroscopy

Outcome Measures

Primary Outcomes (1)

• The functional oral intake scale

  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.

  baseline (before intervention), changes from baseline FOIS at 4 weeks

Secondary Outcomes (5)

• 8-point penetration-aspiration scale (PAS)

  baseline (before intervention), changes from baseline PAS score at 4 weeks

• 11-item functional dysphagia scale (FDS)

  baseline (before intervention), changes from baseline FDS score at 4weeks

• 3-Dimensional (3D) structural MRI

  baseline (before intervention), changes from baseline result of 3-Dimensional (3D) structural MRI at 4 weeks

• Function MRI

  baseline (before intervention), changes from baseline result of fMRI at 4 weeks

• Diffusion tensor imaging

  baseline (before intervention), changes from baseline result of diffusion tensor imaging at 4 weeks

Study Arms (3)

general swallowing therapy

OTHER

including: * oral exercises * tactile stimulation * compensatory techniques * swallowing maneuvers

Other: general swallowing therapy

the NMES therapy with VitalStim therapeutic device

EXPERIMENTAL

The placement of 2-channel electrodes is depended on the dysphagic types and the findings on VFS

Other: NMES therapy

: the combined NMES and general swallowing therapies

ACTIVE COMPARATOR

Other: general swallowing therapy; Other: NMES therapy

Interventions

general swallowing therapy OTHER

including a session of oral exercises, tactile stimulation, compensatory techniques, swallowing maneuvers that are taught to the participants by a speech therapist.

: the combined NMES and general swallowing therapies; general swallowing therapy

NMES therapy OTHER

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.

: the combined NMES and general swallowing therapies; the NMES therapy with VitalStim therapeutic device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• normal neurological examination
• no history of stroke
• no active neurological disorder
• a single cerebral hemispheric stroke
• swallowing difficulty: detected by bedside swallow assessment by a physician while admitting to the rehabilitation unit.
• a single brain stem stroke without prior stroke history
• swallowing difficulties: detected by bedside swallow assessment by a physician while admitting to the rehabilitation unit

You may not qualify if:

• multiple brain lesions due to one episode of stroke
• impaired communication ability due to cognition deficit
• other central or peripheral neurological deficit leading to swallowing difficulty.
• use of an electrically sensitive biomedical device (eg. cardiac pacemaker)
• metal clip in the brain
• pneumonia at the time of enrollment.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (35)

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MeSH Terms

Conditions

Deglutition Disorders; Stroke

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yu Chi Huang, Bachelor

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2017
• First Posted: February 9, 2017
• Study Start: August 1, 2010
• Primary Completion: July 31, 2012
• Study Completion: July 31, 2013
• Last Updated: February 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share