出境医 / 临床实验 / Evaluation of Dysphagia by 6-chnnel Surface Electromyography

Evaluation of Dysphagia by 6-chnnel Surface Electromyography

Study Description
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.


Condition or disease
Deglutition Disorders

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.

Study Design
Layout table for study information
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
Arms and Interventions
Group/Cohort
Young normal group
normal participants below 60 years
Old normal group
normal participants above 60 years
Outcome Measures
Primary Outcome Measures :
  1. Latency [ Time Frame: once at study, when patient enrolled ]
    the latency of muscular activation


Secondary Outcome Measures :
  1. duration [ Time Frame: once at study, when patient enrolled ]
    the contractile duration of evaluated muscles


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Healthy participants
Criteria

Inclusion Criteria of old group

  • Age > 60, without dysphagia, comorbidity

Inclusion Criteria of young control group

  • Age < 60, without dysphagia, comorbidity
Contacts and Locations

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
 (submitted: April 10, 2018)
Latency [ Time Frame: once at study, when patient enrolled ]
the latency of muscular activation
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 10, 2018)
duration [ Time Frame: once at study, when patient enrolled ]
the contractile duration of evaluated muscles
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.

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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
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
  • Young normal group
    normal participants below 60 years
  • Old normal group
    normal participants above 60 years
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 10, 2018)
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

  • Age > 60, without dysphagia, comorbidity

Inclusion Criteria of young control group

  • Age < 60, without dysphagia, comorbidity
Sex/Gender
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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