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CTRI Number  CTRI/2018/10/015992 [Registered on: 10/10/2018] Trial Registered Prospectively
Last Modified On: 16/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   EFFECT OF DIFFERENT FACTORS ON RECOVERY AFTER STROKE 
Scientific Title of Study
Modification(s)  		 DESIGNING AND TESTING A PREDICTIVE MODEL FOR POST STROKE RECOVERY - 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  Dr Ashish Kakkad PT 
Designation  PhD Scholar 
Affiliation  SPB Physiotherapy College Surat 
Address  RK University, Bhavnagar Highway, Kasturbadham, Rajkot, Gujarat
Ugat Bhesan Road, Near Bhesan Jakat Naka, Mora Bhagal, Rander Road, Surat.
Surat
GUJARAT
360020
India 
Phone  91-9824415797  
Fax  0  
Email  kakkadashish@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashish Kakkad PT 
Designation  PhD Scholar 
Affiliation  SPB Physiotherapy College Surat 
Address  RK University, Bhavnagar Highway, Kasturbadham, Rajkot, Gujarat
Ugat Bhesan Road, Near Bhesan Jakat Naka, Mora Bhagal, Rander Road, Surat.
Surat
GUJARAT
360020
India 
Phone  9824415797  
Fax  0  
Email  kakkadashish@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Priyanshu Rathod 
Designation  Guide & Dean 
Affiliation  School of Physiotherapy, RK University, Rajkot 
Address  Faculty of Medicine; School of Physiotherapy, RK University, Rajkot.
Same as above
Surat
GUJARAT
360020
India 
Phone  9426803108  
Fax  0  
Email  priyanshu.rathod@rku.ac.in  
 
Source of Monetary or Material Support  
Ashish Kakkad Self RK University, Rajkot Bhavnagar Road, Kasturbadham, Trumba, Rajkot. Gujarat India 
 
Primary Sponsor  
Name  Ashish Kakkad Self 
Address  SPB physiology college Ugat Bhesan road Mora bhagal Surat 395005 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ashish kakkad  RK University  Bhavnagar Highway, Kasturbadham, Rajkot, Gujarat 360020
Rajkot
GUJARAT 		 9824415797

kakkadashish@yahoo.co.in 
Ashish Kakkad  SPB PHYSIOTHERAPY COLLEGE.  Neuro Department, Room no. 4, Ugat Bhesan Road, Near Bhesan Jakat Naka, Mora Bhagal, Rander Road
Surat
GUJARAT 		 9824415797

kakkadashish@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Ethical Committee (School of Physiotherapy, RK University), recognized by the Central Drug Standard Control Organization (CDSCO), Govt. of India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G819||Hemiplegia, unspecified, (2) ICD-10 Condition: G819||Hemiplegia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All stroke patients who are willing to participate. Both male & female stroke patients.
Mini mental scale examination score >24
Duration of stroke varies from discharge from hospital up to 6 months
 
 
ExclusionCriteria 
Details  Stroke patients who are not cooperative. Stroke patients who have auditory &/or visual deficits. Stroke patients who do not have proper medical records. Patients having another neurological deficit with stroke.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Fugl-Meyer Score  Minimum 0
Maximum 226 
 
Secondary Outcome  
Outcome  TimePoints 
Modified Barthel Index  0 to 20 
 
Target Sample Size   Total Sample Size="162"
Sample Size from India="162" 
Final Enrollment numbers achieved (Total)= "222"
Final Enrollment numbers achieved (India)="222" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2018 
Date of Study Completion (India) 09/11/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Background: Stroke is the first leading cause of disability, second leading cause of death worldwide. Its recovery is important for entire rehabilitation team.

Purpose: Stroke patients who receive physiotherapy may improve in function variably. So there should be identification of different factors to predict functional outcome.

Objective: To design and test predictive model for post stroke recovery.

Setting: Physiotherapy centres of Surat.

Method: For Exploratory study, Selection of stroke patients was done as per selection criteria. After ethical clearance, & CTRI registration, subjects were assessed for 21 factors as independent variables and Fugl Meyer Motor Assessment Score as dependent variable to design  and test model.

Participants: 222 stroke patients.

Outcome measure: Fugl Meyer Motor Assessment Score & Modified Barthel Index

Results: Linear regression at confidence interval 90% was applied and to design predictive model by data of 111 stroke patients. This model was checked on new cohort of 111 stroke patients for its positive and negative predictive values.  

Conclusion: These findings suggest that length of hospitalization is strongest factor for prediction of functional outcome and it was found that model has satisfactory predictive and negative predictive value.

Keywords: Stroke, Predictive factors, Fugl Meyer Motor Assessment Score


 
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