(1) Objectives: The aim of this study was to determine the effects of biofeedback to improve chronic dysphagia in patients with stroke. (2) Design: This study is a before and after treatment, without placebo control, unicentral and in second phase of clinical trial. (3) Setting and conduct: The study population are patients with dysphagia referring to firoozgar hospital physical medicine and rehabilitation clinic via an advertisement. The sample size is 16 people. (4) Participants including major eligibility criteria: Inclusion criteria are patients with chronic dysphagia due to stroke, exclusion criteria are lack of awareness or inappropriate collaboration. (5) Intervention: The patients treated for 10 sessions of biofeedback. To do biofeedback therapy, device electrodes installed under chin, between the mandible and hyoid and front of the neck. Then, patient is asked to do Mendelsohn maneuver. Before the first meeting, the fifth and tenth, the patient ability to swallow food and water, is under review and will be recorded on the chart. Patients will be followed one month after completion of treatment. (6) Main outcome measures (variables): The main outcome of the study are Functional Outcome Intake Scale (FOIS) mean score and sub-mental muscle contractions which will be measured before treatment, immediately and one month after the end of sessions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010324621N3
Registration date:2016-05-23, 1395/03/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-23, 1395/03/03
Registrant information
Name
Tannaz Ahadi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 8207
Email address
ahadi.t@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-03-16, 1394/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of biofeedback therapy in the treatment of patient with chronic dysphagia due to stroke
Public title
The efficacy of exercise therapy in the treatment of chronic swallowing disorder in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Patients with chronic dysphagia due to stroke
Exclusion criteria :Unconsciousness; Failure to obey orders
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran Universiy of Medical Science
Street address
Medical faculty, Iran University of Medical Sience, Hemmat High way
City
Tehran
Postal code
Approval date
2015-05-30, 1394/03/09
Ethics committee reference number
94/د/1309/105.IR.IUMS.REC
Health conditions studied
1
Description of health condition studied
Swallowing disorder
ICD-10 code
R13.1
ICD-10 code description
Dysphagia
Primary outcomes
1
Description
Score obtaining from FOIS Questioner
Timepoint
Before,after last session and 1 month after intervention
Method of measurement
FOIS Questioner
2
Description
Submental muscles contraction amplitude
Timepoint
Before,fifth ,after last session and 1 month after intervention
Method of measurement
Biofeedback device
Secondary outcomes
1
Description
Age
Timepoint
Before the intervention
Method of measurement
Question
2
Description
Sex
Timepoint
Before the intervention
Method of measurement
Question
3
Description
Dysphagia duration
Timepoint
Before the intervention
Method of measurement
Question
4
Description
Type of stroke
Timepoint
Before the intervention
Method of measurement
Medical records
Intervention groups
1
Description
Mendelssohn trainings, in which the hand is placed on the front of neck and patient is ordered to swallow, and biofeedback therapy executed at the same time , for 20 minutes in 10 sessions. A month later , the patient swallowing function will be assessed.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Educational Hospital
Full name of responsible person
Seyyed Mohammad Moeini Taba Zavareh
Street address
Firoozgar hospital, Physical medicine and rehabilitation clinic, Behafarin St, Valiasr square, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Pejman Madani
Street address
Iran University of Medical Sciences, Hemmat high way
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, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Moeini Taba Zavareh
Position
Physiatry Resident
Other areas of specialty/work
Street address
Firoozgar Hospital. Behafarin St. Hafez Ave.
City
Tehran
Postal code
Phone
+98 21 8214 1201
Fax
Email
Mohammadmoeini3050@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tannaz Ahadi
Position
Physical Medicine and Rehabilitation Specialist
Other areas of specialty/work
Street address
Firoozgar Hospital. Behafarin St. Hafez Ave
City
Tehran
Postal code
Phone
+98 21 8214 1201
Fax
Email
Tannaz.ahadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Seyyed Mohammad Moeini Taba Zavareh
Position
Physiatry Resident
Other areas of specialty/work
Street address
Froozgar Hospital. Behafarin St. Hafez Ave.
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)