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

Not Applicable

• Conditions: Dysphagia
• Interventions: Device: Game-based swallow biofeedback; Behavioral: Swallow training without biofeedback

• Registration Number: NCT01967212
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-12
• Status Verified: 2013-10
• Study First Submitted: 2013-10-13
• Study First Submitted QC: 2013-10-17
• Last Update Submitted: 2013-10-17
• Study First Posted: 2013-10-22
• Last Update Posted: 2013-10-22
• Primary Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• on trachea
• cannot follow one command

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Game-based swallow biofeedback	Game-based swallow biofeedback	swallowing training combined with game-based biofeedback in stroke dysphagia patient.
Swallow training without biofeedback	Swallow training without biofeedback	-

Primary Outcome Measures

Name	Time	Method
Hyoid bone displacement on the ultrasound	6-8 weeks

Secondary Outcome Measures

Name	Time	Method
Swallow functional ability on the Functional Oral Intake Scale	6-8 weeks

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan