Overview

This trial is active, not recruiting.

Condition dysphagia
Treatments game-based swallow biofeedback, swallow training without biofeedback
Sponsor National Taiwan University Hospital
Start date December 2012
End date December 2013
Trial size 30 participants
Trial identifier NCT01967212, 201210059RIC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
swallowing training combined with game-based biofeedback in stroke dysphagia patient.
game-based swallow biofeedback 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.
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.
(Active Comparator)
swallow training without biofeedback
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 Outcomes

Measure
Hyoid bone displacement on the ultrasound
time frame: 6-8 weeks

Secondary Outcomes

Measure
Swallow functional ability on the Functional Oral Intake Scale
time frame: 6-8 weeks

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: - stroke - above 18 years-old - pharyngeal stage dysphagia Exclusion Criteria: - on trachea - cannot follow one command

Additional Information

Official title Swallowing Training Combined With Game-based Biofeedback in Post-stroke Dysphagia
Principal investigator Tyng Guey Wang, PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by National Taiwan University Hospital.