Back to resultsSwallowing Training Combined With Game-based Biofeedback in Post-stroke Dysphagia
Primary Purpose
Dysphagia
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Game-based swallow biofeedback
Swallow training without biofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Dysphagia focused on measuring stroke, swallowing training, game-based, biofeedback
Eligibility Criteria
Inclusion Criteria:
- stroke
- above 18 years-old
- pharyngeal stage dysphagia
Exclusion Criteria:
- on trachea
- cannot follow one command
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Game-based swallow biofeedback
Swallow training without biofeedback
Arm Description
swallowing training combined with game-based biofeedback in stroke dysphagia patient.
Outcomes
Primary Outcome Measures
Hyoid bone displacement on the ultrasound
Secondary Outcome Measures
Swallow functional ability on the Functional Oral Intake Scale
Full Information
NCT ID
NCT01967212
First Posted
October 13, 2013
Last Updated
October 17, 2013
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01967212
Brief Title
Swallowing Training Combined With Game-based Biofeedback in Post-stroke Dysphagia
Official Title
Swallowing Training Combined With Game-based Biofeedback in Post-stroke Dysphagia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
stroke, swallowing training, game-based, biofeedback
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Game-based swallow biofeedback
Arm Type
Experimental
Arm Description
swallowing training combined with game-based biofeedback in stroke dysphagia patient.
Arm Title
Swallow training without biofeedback
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Game-based swallow biofeedback
Other Intervention Name(s)
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.
Intervention Description
The intervention are divided into two parts：
Traditional swallowing training 30 min by speech therapist.
Game-based biofeedback combined with Mendelsohn's maneuver and effortful swallow 30 min by investigator.
Intervention Type
Behavioral
Intervention Name(s)
Swallow training without biofeedback
Intervention Description
The intervention are divided into two parts：
Traditional swallowing training 30 min by speech therapist.
Mendelsohn's maneuver and effortful swallow without biofeedback 30 min.
Primary Outcome Measure Information:
Title
Hyoid bone displacement on the ultrasound
Time Frame
6-8 weeks
Secondary Outcome Measure Information:
Title
Swallow functional ability on the Functional Oral Intake Scale
Time Frame
6-8 weeks
Other Pre-specified Outcome Measures:
Title
SWAL-QOL Questionnaire
Time Frame
6-8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stroke
above 18 years-old
pharyngeal stage dysphagia
Exclusion Criteria:
on trachea
cannot follow one command
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyng Guey Wang, PHD
Organizational Affiliation
Department of Physical Medicine and Rehabilitation,National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
12. IPD Sharing Statement
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Swallowing Training Combined With Game-based Biofeedback in Post-stroke Dysphagia
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