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Swallowing Training Combined With Game-based Biofeedback in Post-stroke Dysphagia

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ClinicalTrials.gov Identifier: NCT01967212
Recruitment Status : Unknown
Verified October 2013 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 22, 2013
Last Update Posted : October 22, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
The purpose of this study is to determine whether swallowing training combined with game-based biofeedback is effective in the treatment of dysphagia due to stroke.

Condition or disease Intervention/treatment Phase
Dysphagia Device: Game-based swallow biofeedback Behavioral: Swallow training without biofeedback Not Applicable

Detailed Description:

Swallowing maneuvers are very effective if done correctly, but to evaluate the use of force and the extent of laryngeal elevation is very difficult.

The therapist often requests the patient to "swallow hard" or "maintain laryngeal elevation". However, it is difficult to provide appropriate feedback to the patient, because it's hard to see the throat muscle contraction and bone displacement,the real point of the force is not clear, only oral and tactile feedback is inadequate and when combined with sensory loss, fatigue or cognition impairment.

Biofeedback is defined as "the technique of using equipment (usually electronic) to reveal internal physiological events by visual and auditory signals, to teach patients to manipulate the intrinsic physiological activity (Basmajian, 1989).The rationale is thus that if a patient sees his muscle activity, rather than just feels his muscles contract, he will be able to contract his muscles more fiercely and therefore he will be able to train his muscles faster.

Past studies have shown that biofeedback can help nerve injury patients control their physiological activities such as swallowing training.

The purpose of this study is to determine whether swallowing training combined with game-based biofeedback is effective in the treatment of dysphagia due to stroke.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Swallowing Training Combined With Game-based Biofeedback in Post-stroke Dysphagia
Study Start Date : December 2012
Estimated Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Game-based swallow biofeedback
swallowing training combined with game-based biofeedback in stroke dysphagia patient.
Device: Game-based swallow biofeedback

The intervention are divided into two parts:

  1. Traditional swallowing training 30 min by speech therapist.
  2. Game-based biofeedback combined with Mendelsohn's maneuver and effortful swallow 30 min by investigator.
Other Name: The system was developed by Professor Chen, Jia-Jin and Dr. Li, Chih-Ming from Taiwan's National Cheng Kung University, Institute of Biomedical Engineering.

Active Comparator: Swallow training without biofeedback Behavioral: Swallow training without biofeedback

The intervention are divided into two parts:

  1. Traditional swallowing training 30 min by speech therapist.
  2. Mendelsohn's maneuver and effortful swallow without biofeedback 30 min.




Primary Outcome Measures :
  1. Hyoid bone displacement on the ultrasound [ Time Frame: 6-8 weeks ]

Secondary Outcome Measures :
  1. Swallow functional ability on the Functional Oral Intake Scale [ Time Frame: 6-8 weeks ]

Other Outcome Measures:
  1. SWAL-QOL Questionnaire [ Time Frame: 6-8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stroke
  • above 18 years-old
  • pharyngeal stage dysphagia

Exclusion Criteria:

  • on trachea
  • cannot follow one command

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967212


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10048
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Tyng Guey Wang, PHD Department of Physical Medicine and Rehabilitation,National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01967212     History of Changes
Other Study ID Numbers: 201210059RIC
First Posted: October 22, 2013    Key Record Dates
Last Update Posted: October 22, 2013
Last Verified: October 2013

Keywords provided by National Taiwan University Hospital:
stroke
swallowing training
game-based
biofeedback

Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases