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

NCT01967212 | Unknown DMC

• 1 other identifier: 201210059RIC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia

Keywords

stroke; swallowing training; game-based; biofeedback

Outcome Measures

Primary Outcomes (1)

• Hyoid bone displacement on the ultrasound

  6-8 weeks

Secondary Outcomes (1)

• Swallow functional ability on the Functional Oral Intake Scale

  6-8 weeks

Other Outcomes (1)

• SWAL-QOL Questionnaire

  6-8 weeks

Study Arms (2)

Game-based swallow biofeedback

EXPERIMENTAL

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

Device: Game-based swallow biofeedback

Swallow training without biofeedback

ACTIVE COMPARATOR

Behavioral: Swallow training without biofeedback

Interventions

Game-based swallow biofeedback 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.

Also known as: 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.

Game-based swallow biofeedback

Swallow training without biofeedback 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.

Swallow training without biofeedback

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• on trachea
• cannot follow one command

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 10048, Taiwan

Location

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Tyng Guey Wang, PHD

  Department of Physical Medicine and Rehabilitation,National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2013
• First Posted: October 22, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Last Updated: October 22, 2013

Record last verified: 2013-10

Locations

TW (1)