DysphagiaNCT01967212
Swallowing Training Combined With Game-based Biofeedback in Post-stroke Dysphagia
A study testing Game-based swallow biofeedback and Swallow training without biofeedback in people with Dysphagia, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dysphagia
- What is being tested?
- Game-based swallow biofeedback and Swallow training without biofeedback
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stroke
- above 18 years-old
- pharyngeal stage dysphagia
Who cannot join
- on trachea
- cannot follow one command
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dysphagia
- Being tested
- Game-based swallow biofeedback, Swallow training without biofeedback
- Keywords
- stroke, swallowing training, game-based, biofeedback
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game-based swallow biofeedbackDevice
Also called 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.
Swallow training without biofeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Game-based swallow biofeedback | Experimental | swallowing training combined with game-based biofeedback in stroke dysphagia patient. Receives: Device: Game-based swallow biofeedback |
| Swallow training without biofeedback | Active comparator | Not described Receives: Behavioral: Swallow training without biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyoid bone displacement on the ultrasound
Measured: 6-8 weeks
Secondary outcomes (1)
Swallow functional ability on the Functional Oral Intake Scale
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tyng Guey Wang, PHD, Principal investigator, Department of Physical Medicine and Rehabilitation,National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967212
- Sponsor's protocol ID
- 201210059RIC
- Status last verified
- Oct 2013
- First submitted
- 13 Oct 2013
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swallowing Training Combined With Game-based Biofeedback in Post-stroke Dysphagia
- ClinicalTrials.gov ID
- NCT01967212
- Acronym / sponsor ID
- 201210059RIC
- Conditions
- Dysphagia
- Keywords
- stroke, swallowing training, game-based, biofeedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Game-based swallow biofeedback | Experimental | Device: Game-based swallow biofeedbackswallowing training combined with game-based biofeedback in stroke dysphagia patient. |
| Swallow training without biofeedback | Active comparator | Behavioral: Swallow training without biofeedback |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- stroke
- above 18 years-old
- pharyngeal stage dysphagia
Key exclusion criteria (2 listed)
- on trachea
- cannot follow one command
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game-based swallow biofeedbackAlso: 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： 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. | Device | Game-based swallow biofeedback |
| Swallow training without biofeedbackThe 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. | Behavioural | Swallow training without biofeedback |
Primary outcome
Hyoid bone displacement on the ultrasound
Time frame: 6-8 weeks
1 secondary outcome
Swallow functional ability on the Functional Oral Intake Scale
Time frame: 6-8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyng Guey Wang, PHD principal investigator
Department of Physical Medicine and Rehabilitation,National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game-based swallow biofeedback and Swallow training without biofeedback in people with Dysphagia, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyoid bone displacement on the ultrasound (time frame: 6-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2013.