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Evaluation of Dysphagia by 6-chnnel Surface Electromyography
The natural process of aging affects a few very specific timing parameters such as swallow reaction time and hyoid one movement velocity.
Many swallow timing and bolus transit parameters appear to be unaffected by aging. We want to know the changes of kinematic variables according to the aging process.
First hypothesis: There are probably be a protection mechanism that blocks functional loss progressing to kinematic abnormality. Muscle activation sequence change (i.e duration or amplitude) of the oropharyngeal muscles play an important role.
Second hypothesis: Age-related differences in muscle activation patterns will also appear differently depending on the characteristics of swallowed food.
| Condition or disease |
|---|
| Deglutition Disorders |
Inclusion criteria
Inclusion criteria of healthy older adults : Age > 60, without dysphagia, comorbidity
Inclusion criteria of young control group
: Age < 60, without dysphagia, comorbidity
No prior history of swallowing difficulty or history of central nervous system disease, and none were taking medication that are known to affect swallowing.
Surface EMG was performed at bilateral suprahyoid, thyrohyoid, sternothyroid and pharyngeal constrictors. The latency of activation and termination was checked.
| Study Type : | Observational |
| Actual Enrollment : | 40 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | Evaluation of Dysphagia by 6-chnnel Surface Electromyography and Preliminary Study for Design 6-channel Electrical Stimulation |
| Actual Study Start Date : | July 4, 2016 |
| Actual Primary Completion Date : | November 21, 2017 |
| Actual Study Completion Date : | November 21, 2017 |
| Group/Cohort |
|---|
|
Young normal group
normal participants below 60 years
|
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Old normal group
normal participants above 60 years
|
- Latency [ Time Frame: once at study, when patient enrolled ]the latency of muscular activation
- duration [ Time Frame: once at study, when patient enrolled ]the contractile duration of evaluated muscles
| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria of old group
- Age > 60, without dysphagia, comorbidity
Inclusion Criteria of young control group
- Age < 60, without dysphagia, comorbidity
No Contacts or Locations Provided
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 2, 2018 | ||||
| First Posted Date | April 11, 2018 | ||||
| Last Update Posted Date | July 23, 2020 | ||||
| Actual Study Start Date | July 4, 2016 | ||||
| Actual Primary Completion Date | November 21, 2017 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Latency [ Time Frame: once at study, when patient enrolled ] the latency of muscular activation
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
duration [ Time Frame: once at study, when patient enrolled ] the contractile duration of evaluated muscles
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Evaluation of Dysphagia by 6-chnnel Surface Electromyography | ||||
| Official Title | Evaluation of Dysphagia by 6-chnnel Surface Electromyography and Preliminary Study for Design 6-channel Electrical Stimulation | ||||
| Brief Summary |
The natural process of aging affects a few very specific timing parameters such as swallow reaction time and hyoid one movement velocity. Many swallow timing and bolus transit parameters appear to be unaffected by aging. We want to know the changes of kinematic variables according to the aging process. First hypothesis: There are probably be a protection mechanism that blocks functional loss progressing to kinematic abnormality. Muscle activation sequence change (i.e duration or amplitude) of the oropharyngeal muscles play an important role. Second hypothesis: Age-related differences in muscle activation patterns will also appear differently depending on the characteristics of swallowed food. |
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| Detailed Description |
Inclusion criteria Inclusion criteria of healthy older adults : Age > 60, without dysphagia, comorbidity Inclusion criteria of young control group : Age < 60, without dysphagia, comorbidity No prior history of swallowing difficulty or history of central nervous system disease, and none were taking medication that are known to affect swallowing. Surface EMG was performed at bilateral suprahyoid, thyrohyoid, sternothyroid and pharyngeal constrictors. The latency of activation and termination was checked. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Healthy participants | ||||
| Condition | Deglutition Disorders | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
40 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | November 21, 2017 | ||||
| Actual Primary Completion Date | November 21, 2017 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria of old group
Inclusion Criteria of young control group
|
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| Sex/Gender |
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| Ages | 20 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03494361 | ||||
| Other Study ID Numbers | B-1604/344-003 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Ju Seok Ryu, Seoul National University Hospital | ||||
| Study Sponsor | Seoul National University Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Seoul National University Hospital | ||||
| Verification Date | July 2020 | ||||
