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

NCT ID: NCT01967212

Last Updated: 2013-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Dysphagia

Keywords

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stroke swallowing training game-based biofeedback

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Game-based swallow biofeedback

swallowing training combined with game-based biofeedback in stroke dysphagia patient.

Group Type EXPERIMENTAL

Game-based swallow biofeedback

Intervention Type DEVICE

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.

Swallow training without biofeedback

Group Type ACTIVE_COMPARATOR

Swallow training without biofeedback

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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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.

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* on trachea
* cannot follow one command
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tyng Guey Wang, PHD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine and Rehabilitation,National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, Taipei, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201210059RIC

Identifier Type: -

Identifier Source: org_study_id