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

October 17, 2013 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • on trachea
  • cannot follow one command

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hyoid bone displacement on the ultrasound
Time Frame: 6-8 weeks
6-8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Swallow functional ability on the Functional Oral Intake Scale
Time Frame: 6-8 weeks
6-8 weeks

Other Outcome Measures

Outcome Measure
Time Frame
SWAL-QOL Questionnaire
Time Frame: 6-8 weeks
6-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Tyng Guey Wang, PHD, Department of Physical Medicine and Rehabilitation,National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

October 13, 2013

First Submitted That Met QC Criteria

October 17, 2013

First Posted (Estimate)

October 22, 2013

Study Record Updates

Last Update Posted (Estimate)

October 22, 2013

Last Update Submitted That Met QC Criteria

October 17, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201210059RIC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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