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

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01967212
• Other study ID #: 201210059RIC
• Status: Active, not recruiting
• Phase: N/A
• First received: October 13, 2013
• Last updated: October 17, 2013
• Start date: December 2012

Study information

• Verified date: October 2013
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• stroke

• above 18 years-old

• pharyngeal stage dysphagia

Exclusion Criteria:

• on trachea

• cannot follow one command

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Device:
• Game-based swallow biofeedback
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.

Behavioral:
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SWAL-QOL Questionnaire		6-8 weeks	Yes
Primary	Hyoid bone displacement on the ultrasound		6-8 weeks	Yes
Secondary	Swallow functional ability on the Functional Oral Intake Scale		6-8 weeks	Yes