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CTRI Number  CTRI/2017/05/008482 [Registered on: 04/05/2017] Trial Registered Prospectively
Last Modified On: 27/03/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   The effect of Task Oriented Circuit Training on Hand function in people with one-sided weakness living in the society 
Scientific Title of Study   Influence of Task Oriented Circuit Training on Upper limb Function in Community Dwelling Stroke Survivors 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shruti Deshpande 
Designation  Postgraduate student 
Affiliation  Manipal University 
Address  Department of Physiotherapy School of Allied Health sciences Manipal University Manipal

Udupi
KARNATAKA
576104
India 
Phone  9673004110  
Fax    
Email  shrutideshpande93@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sidhiprada Mohapatra 
Designation  Assistant Professor 
Affiliation  Manipal University 
Address  Department of Physiotherapy School of Allied Health Sciences Manipal University Manipal

Udupi
KARNATAKA
576104
India 
Phone  8050730675  
Fax    
Email  sidhi.mohapatra@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Girish N 
Designation  Assistant Professor 
Affiliation  Manipal University 
Address  Department of Physiotherapy School of Allied Health Sciences Manipal University Manipal

Udupi
KARNATAKA
576104
India 
Phone  9886782114  
Fax    
Email  girish.n@manipal.edu  
 
Source of Monetary or Material Support  
Rural Maternity Care and Welfare Centre (RMCW), Department of Physiotherapy, Bollargudde,Udyavara-574118, Udupi, Karnataka 
 
Primary Sponsor  
Name  Shruti Deshpande 
Address  Department of Physiotherapy School of Allied Health Sciences Manipal University Manipal 
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 
Shruti Deshpande  Rural Maternity and Child Welfare Centre (RMCW)  RMCW, Department of Physiotherapy,Bollargudde, Udyavara-574118
Udupi
KARNATAKA 		 9673004110

shrutideshpande93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Cerebrovascular Accident (Stroke),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multi activity Workstation  Workstation consists of 12 tasks related to strength, coordination, dexterity and range of motion. These will be performed for a period of 6 weeks, twice a week, one hour per session 
Comparator Agent  Standard Therapy  This therapy includes all the execises that the patient will be normally performing. Consists of strengthening and range of motion exercises, cycling, stair climbing, walking 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Adults more than 45 years of age
Both males and females
Single episode of stroke
Onset more than 6 months
Mini Mental State Examination (MMSE) score more than 23
Voluntary Control Grade for affected Upper Limb more than 3
Passive wrist extension of affected upper limb more than 20 degrees
Able to maintain standing position for 5 minutes without assistance
Ambulate with or without assistive device 
 
ExclusionCriteria 
Details  Other neurological conditions in addition to stroke (parkinson, multiple sclerosis, convulsions etc)
Musculoskeletal problems (shoulder dislocation/subluxation, fixed deformity of hand, shoulder hand syndrome etc)
Complete sensory loss of upper limb
Visually impaired 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Wolf Motor Function Test  The WMFT will be assessed at the beginning, at the 6th week and again at 12th week of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Chedoke Arm and Hand Activity Inventory  The CAHAI will be assessed at the beginning, at the 6th week and again at 12th week of intervention 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   N/A 
Date of First Enrollment (India)   22/05/2017 
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="1"
Days="2" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The objective of this study is to find the influence of task oriented circuit training on upper limb function in community dwelling stroke survivors using Wolf Motor Function Test(WMFT) and Chedoke Arm and Hand Activity Inventory(CAHAI). The sample size of the study is a 180. The participants will be divided into two intervention groups- one will be the standard therapy protocol which will include the range of motion, coordination, stretching  and strengthening exercises to upper extremities. The other intervention is given on the Multi activity workstation which consists of 12 tasks of coordination, dexterity, range of motion and strengthening. The interventions will be given for a period of 60 minutes per session, two sessions per week for a period of 12 weeks (6 weeks each). The participants will be randomly allocated into the therapy groups by coin toss method. The participant will undergo the first phase of intervention for six weeks and post-intervention assessment of WMFT and CAHAI will be undertaken. The participant then has to cross-over to the second phase of intervention for another six weeks, following which assessments of WMFT and CAHAI will be repeated.  
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