Comparative Study of effectiveness of Combined treatment of dysphagia(Traditional Dysphagia Therapy &Transcranial Magnetic Stimulation) and other two treatments in Stroke Patients".
The aim of this study is comparative study of the process and effects of Traditional Dysphagia Therapy, Transcranial Magnetic Stimulation and Combination of them in Stroke patients with Dysphagia.
Design of the study is randomized clinical trial and double blinded.
Inclusion Criteria:
1-Subacute Stroke patient with dysphagia
2-Suffering from dysphagia and aspiration diagnosed by MASA
3- No dysphagia therapy.
Exclusion Criteria:
1- Dementia and Alzheimer and dysphagia due to other neurogenic Disease
2- Severe Aphasia
3_ Dysphagia due to drug toxicity
4_ Agitation, with decreased level of consciousness, or otherwise noncompliant
15 Stroke patients with dysphagia participate in three groups. The first group are provided traditional dysphagia therapy. This protocol is included computational treatments , postural changes, oromotor exercise and swallowing manures. This treatment is provided for 30 min in 3 days of week and for 6 weeks. This group is control. The second group is provided inhibitory Repetitive Transcranial Magnetic Stimulations in healthy hemisphere. Stimulations were performed at 1 Hz for 20 min at 20% above the threshold value. It was repeated each day for 5 days. The third group is given combined treatment . Firstly patients are given rTMS for 5 day and simultaneously are given TDT for 3days in week for 6 weeks. MASA Test will be performed before, end of fifth session, end of tenth session, end of fourth week and the end of sixth week and determined existence and severity of dysphagia and aspiration in all of the patients in every group.
General information
Acronym
TDT TMS
IRCT registration information
IRCT registration number:IRCT201202218629N1
Registration date:2013-03-27, 1392/01/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-27, 1392/01/07
Registrant information
Name
Leila Ghelichi
Name of organization / entity
Tehran University Of Medical Sciences, Rehabilitation School
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
l-ghelichi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study of effectiveness of Combined treatment of dysphagia(Traditional Dysphagia Therapy &Transcranial Magnetic Stimulation) and other two treatments in Stroke Patients".
Public title
Treatment of Swallowing disorders in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
1-Subacute(at least one week after the accuring of stroke) Stroke
patient with dysphagia
2-Patients' rang of age is between 20-80
3-Patients from Both gender
4-Suffering from dysphagia and aspiration diagnosed by MASA(Mann
Assessment of Swallowing Ability)
5- they have not received any Dysphagia therapy.
Exclusion Criteria:
1- Dementia and Alzheimer and dysphagia due to other neurogenic Disease
2_ Significant reflux
3- Severe Aphasia
4_ Dysphagia due to drug toxicity
5- severe Reflux
6_ Agitation, with decreased level of consciousness, or otherwise
noncompliant
7_ Pregnancy
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Sixth floor, Center building of University, Qods street, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2012-12-26, 1391/10/06
Ethics committee reference number
د/130/2435
Health conditions studied
1
Description of health condition studied
Dysphagia
ICD-10 code
R13
ICD-10 code description
Difficulty in swallowing
Primary outcomes
1
Description
Score of MASA test
Timepoint
Before treatment,5th session,10th session,the end of forth week of treatment and the end of sixth week of treatment
Method of measurement
MASA test
2
Description
Dysphagia
Timepoint
Before treatment,5th session,10th session,the end of forth week of treatment and the end of sixth week of treatment
Method of measurement
MASA test
3
Description
Severity of Dysphagia
Timepoint
Before treatment,5th session,10th session,the end of forth week of treatment and the end of sixth week of treatment
Method of measurement
MASA test
4
Description
Aspiration
Timepoint
Before treatment,5th session,10th session,the end of forth week of treatment and the end of sixth week of treatment
Method of measurement
MASA test
5
Description
Severity of Aspiration
Timepoint
Before treatment,5th session,10th session,the end of forth week of treatment and the end of sixth week of treatment
Method of measurement
MASA test
Secondary outcomes
empty
Intervention groups
1
Description
Control Group : The first group are provided traditional dysphagia therapy. this protocol is included competional treatments , postural changes, oromotor exercies and swallowind manuers. this treatments is provided in 30 min for 3 days of week and for 6 weeks.
Category
Rehabilitation
2
Description
Intervention Group : The second group are provided inhibitory Repatative Transcranial Magnetic Stimulations (rTMS) in healty hemisphere. Stimulations were performed at 1 Hz for 20 min at 20% above the threshold value. It was repeate each day for 5 days.
All stimulations were carried out using a Magstim superrapi stimulator (Magstim, Whitland, Dyfed, UK) equipped with a air-refreshed, double, 70-mm, figure-of-eight coil (peak magnetic field = 2 T), at the maximal output of the stimula. The vertex of the cranium was first identified. The coil was then positioned 2–4 cm anteriorlyand 4–6 cm laterally and moved around in this area to obtain the highest electromyographic mylohyoid response.
Category
Treatment - Devices
3
Description
Intervention Group:
The third group is given combined treatment(TDT and rTMS). Firstly patients are given rTMS for 5 day and Simultaneously are given TDT for 3days in week for 6 weeks. In every day that is provided two treatment Simultaneously patients are given rTMS for 20 min and after short rest (5-10 min) another treatment (TDT) is provided for 30 min by speech& language Pathologist
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Fotoohi
Street address
Center building of Tehran University of Medical Sciences, Qods Steert, Keshavarz Blve, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?