The present study will investigate the effect of intensive treatment on language skills. Patients consist of aphasia patients with at least one year post-stroke and able to produce one word. In terms of the study design (single-subject), and type of intervention, 2 patients will be entered to treatment for 9 weeks. In the first three weeks without treatment, and after every treatment week (from fourth week to seventh week), Persian Aphasia Test will be tested. Eighth and ninth week will be considered as follow up of effect of treatment. Patients will get treatment from fourth to seventh week, three days per week and for 150 minutes every day and totally 30 hours during the study. Treatment materials include 60 paired black and white pictures that patients should ask each together verbally only. Treatment activity is performed in a group consist 2 patients as well as one clinician.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107317168N1
Registration date:2015-03-25, 1394/01/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-25, 1394/01/05
Registrant information
Name
Ahmad Reza Khatoonabadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7798 2789
Email address
khatoonabadi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-04-20, 1394/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of constraint language therapy on recovery of Speech & Language deficits in aphasic patients
Public title
The treatment of speech and language disorders in patients with aphasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: post-stroke>1 year, right handed, age<65, ability to produce single-word at least, normal or corrected to normal of vision and hearing,
Exclusion criteria: more than once stroke, brain injury,
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
2
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran-School of rehabilitation
City
Tehran
Postal code
-
Approval date
2014-08-19, 1393/05/28
Ethics committee reference number
92-03-32-24427
Health conditions studied
1
Description of health condition studied
Aphasia
ICD-10 code
R47.8
ICD-10 code description
Other and unspecified speech disturbances
Primary outcomes
1
Description
comprehension
Timepoint
pre-post- test
Method of measurement
test
2
Description
speaking
Timepoint
pre-post test
Method of measurement
test
3
Description
repetition
Timepoint
pre-post test
Method of measurement
test
Secondary outcomes
1
Description
speaking
Timepoint
two weeks aftr enterance-one month after enterance
Method of measurement
test
2
Description
repetition
Timepoint
two weeks aftr enterance-one month after enterance
Method of measurement
test
Intervention groups
1
Description
Constraint language therapy-30 hours-three sessions per week
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Speech Therapy Clinic of Tehran university of Medical sciences
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
khatoonabadi
Street address
Enghelab st., piche shemiran, school of rehabilitation
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 Medicla Sciences
Full name of responsible person
Ahmad Reza Khatoonabadi
Position
PhD of speech therapy-Academic member
Other areas of specialty/work
Street address
Speech therapy Department, School of Rehabilitation, EnghelabSt., Tehran
City
Tehran
Postal code
Phone
+98 21 7763 6042
Fax
Email
khatoonabadi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ahmad Reza Khatoonabadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Speech Therapy Department, School of Rehabilitation, Enghelab st., Tehran
City
Tehran
Postal code
Phone
+98 21 7763 6042
Fax
Email
khatoonabadi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ahmad Reza khatoonabadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Speech Therapy Department, School of Rehabilitation, Enghelab St., Tehran
City
Tehran
Postal code
-
Phone
+98 77536042
Fax
-
Email
khatoonabadi@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)