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CTRI Number  CTRI/2020/07/026853 [Registered on: 28/07/2020] Trial Registered Prospectively
Last Modified On: 17/07/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Tracking the improvements of a speech therapy technique in individuals who have lost their language after a stroke that primarily focuses on their naming difficulties 
Scientific Title of Study   Generalization of phonological based approach - An exploratory study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Adhvika Shetty 
Designation  Masters Student 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing,Manipal College of Health Professions, Manipal, Karnataka- 576104

Udupi
KARNATAKA
576104
India 
Phone  9035037729  
Fax    
Email  adhvikas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gopee Krishnan 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing,Manipal College of Health Professions, Manipal, Karnataka- 576104

Udupi
KARNATAKA
576104
India 
Phone  9036459815  
Fax    
Email  krishnan.g@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Adhvika Shetty 
Designation  Masters Student 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing,Manipal College of Health Professions, Manipal, Karnataka- 576104

Udupi
KARNATAKA
576104
India 
Phone  9035037729  
Fax    
Email  adhvikas@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Adhvika Shetty 
Address  Department of Speech and Hearing, Manipal college of Health Professions, Manipal - 576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Adhvika Shetty  Kasturba Medical Hospital  Department of Speech and Hearing,Manipal - 576104
Udupi
KARNATAKA 		 9035037729

adhvikas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I693||Sequelae of cerebral infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Phonological component Analysis  Phonological component analysis is a type of speech therapy technique/intervention that focuses on helping individuals with Aphasia having naming difficulties (anomia. Here the names of various items are elicited from the client by providing phonological (sound based cues)in order to help them name the pictures/ objects. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1)Individuals should be bilingual (L1- Tulu, L2- Kannada).
2) Individuals with single left- hemisphere cerebrovascular accident at least 6 months prior to the time of enrolment to this study.
3) Diagnosed to have Aphasia by an experienced speech language pathologist (Western Aphasia Battery - Kannada).
4) Deficits in naming abilities – individuals who exhibit predominantly phonologically based deficits in naming.
5) Participants to be recruited from in and around Kasturba Medical Hospital who can be approached at their residence for therapy.
 
 
ExclusionCriteria 
Details  1)Premorbid language issues.
2)Visual perception deficits.
3)Individuals with severe forms of aphasias.
4)Individuals with severe dysarthria and or apraxia.
5)Any other neurological conditions that can interfere with the intervention or purpose of the study.
6)Currently enrolled for speech therapy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual analysis and West (Weighted Statistics) - To determine the level of within language and cross lingusitic generalization  January 2021 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="6"
Sample Size from India="6" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/08/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The aim of this study is to investigate the generalization of phonological component analysis (PCA), for the intervention of naming deficits in aphasia. The objectives of this study are:

1)      To examine within-language generalisation effect of PCA-based intervention in aphasia.

2)      To examine the effect of the PCA-based treatment on cross-linguistic generalization.

Need for the study : Due to the dearth in literature regarding generalization of Phonological component analysis, we intend to explore the generalization of Phonological Component Analysis within and across languages. Individuals with Aphasia, in the Indian scenario, are mostly bilinguals. Our study could further help us in choosing the relatively beneficial language for therapy.

Summary of the study :  Six patients with aphasia who can speak both Kannada and Tulu fluently will be recruited in the study. The 6 patients will be divided into 2 groups (3 each) Group 1 will be trained in Kannada and the improvements will be tested in Tulu. Group 2 will be trained in Tulu and improvements will be tested in Kannada. Each session will last for 45 mins and a total of 21 sessions will be conducted for each client. This training will require the clients to only name the pictures shown to him or her. 

 
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