A comparative study of the effects of two swallowing therapy approaches
(Shaker exercise and surface electrotherapy) on the muscle activities and
clinical swallowing function in healthy older adults
1) Objectives: The present study aims to investigate and compare the effects of two swallowing approaches(shaker exercise and surface electroterapy) on the myoelectric activity of the neck muscles during swallowing and also on the clinical swallowing function of healthy older adults.
2) Design: Not blinded randomized controlled trial
3) Setting and conduct: After a primary interview and assessment, the older adults eligible for this study will receive a period of treatment. This sample will be randomly divided into two treatment groups. Swallowing assessments will be performed before and after the treatment period.
4) Participants including major eligibility criteria: The main inclusion criteria will include over the age of 60; no history of neurological and/or myopathic disorders; no history of difficulties in swallowing function.
The main exclusion criteria will include impropriety of the recorded EMG signal; no regular participation in the intervention sessions.
20 non-dysphagic older adults will participate in this study.
5) Interventions: Twenty persons will be randomly assigned to the Shaker exercise or electrotherapy group and will receive treatment for 2 weeks.
6) Main outcome measures: The effects of the mentioned treatment approaches will be studied on the electrophysiologic function of swallowing muscles including the masseter muscle, the submental and infrahyoid muscles during swallowing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031026999N1
Registration date:2016-05-09, 1395/02/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-09, 1395/02/20
Registrant information
Name
Marziyeh Poorjavad
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 935 404 5795
Email address
m-poorjavad@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Sciences
Expected recruitment start date
2016-05-09, 1395/02/20
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effects of two swallowing therapy approaches
(Shaker exercise and surface electrotherapy) on the muscle activities and
clinical swallowing function in healthy older adults
Public title
The effects of two swallowing therapy approaches on swallowing in older adults.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Over the age of 60; having a desire to involve in such a health program; no history of neurological (such as stroke, TBI, MS, ALS, Parkinson, epilepsy and dementia) and/or myopathic disorders; no history of head and neck cancer; no history of chronic neck pain or other neck problems; no history of difficulties in swallowing function.
Exclusion criteria:
Impropriety of the recorded EMG signals; an intolerance of surface electrotherapy on the neck; no regular participation in the intervention sessions.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Corner of Ghods St, Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
Approval date
2014-06-03, 1393/03/13
Ethics committee reference number
IR.TUMS.REC.1394.2180
Health conditions studied
1
Description of health condition studied
aging
ICD-10 code
R94.1
ICD-10 code description
Abnormal results of function studies of peripheral nervous system and special senses
Primary outcomes
1
Description
Mean of submental muscles activity during swallowing
Timepoint
Before intervention. immediately after intervention
Method of measurement
Micro volt. sEMG
2
Description
Mean of infrahyoid muscles activity during swallowing
Timepoint
Before intervention. immediately after intervention
Method of measurement
Micro volt. sEMG
3
Description
Duration of submental muscles activity during swallowing
Timepoint
Before intervention. immediately after intervention
Method of measurement
Seconds, sEMG
4
Description
Duration of infrahyoid muscles activity during swallowing
Timepoint
Before intervention. immediately after intervention
Method of measurement
Seconds, sEMG
5
Description
Time to peak of submental muscles activity during swallowing
Timepoint
Before intervention. immediately after intervention
Method of measurement
Seconds, sEMG
6
Description
Time to peak of infrahyoid muscles activity during swallowing
Timepoint
Before intervention. immediately after intervention
Method of measurement
Seconds, sEMG
7
Description
Median frequency of submental muscles activity during swallowing
Timepoint
Before intervention. immediately after intervention
Method of measurement
Hertz, sEMG
8
Description
Median frequency of infrahyoid muscles activity during swallowing
Timepoint
Before intervention. immediately after intervention
Method of measurement
Hertz, sEMG
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: Surface electrotherapy on the submental muscles bilaterally for 2 weeks (five consecutive daily sessions per week) using a surface electrical stimulator device with stimulation frequency of 100 Hz, 45 minutes per day.
Category
Rehabilitation
2
Description
Control group: The Head Lift Exercise (Shaker exercise) for 2 weeks (five consecutive daily sessions per week) including 3 sets of exercise a day which consisted of isometric and isokinetic phases of neck exercise. Briefly, the isometric portion of the HLE consists of three sustained 60-s head lifts in the supine position with a 60-s rest period between each trial. This portion is followed by 30 consecutive repetitions of head-lifts without holding (isokinetic part of the HLE).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Emamzadeh yahya neighborhood house
Full name of responsible person
Ms.Forughi
Street address
Emamzadeh yahya neighborhood house, western Abshar alley, Rey street, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Dr. Masud Yunesian
Street address
Tehran University of Medical Sciences, Corner of Ghods St, Keshavarz Blvd, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Marziyeh Poorjavad
Position
PhD student of speech therapy
Other areas of specialty/work
Street address
Department of Speech Therapy, Rehabilitation faculty, Tehran University of Medical Sciences: Pich Shemiran, Enghelab St, Tehran