FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/07/020241 [Registered on: 17/07/2019] Trial Registered Prospectively
Last Modified On: 15/07/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effects of Trunk exercise on Trunk performance on stroke subjects:A randomized control trial. 
Scientific Title of Study   The effects of Trunk exercises on Trunk strength, control, balance and functional outcome in sub acute stroke subjects:A Randomized Control Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyanka Singh 
Designation  Associate professor 
Affiliation  Sikkim Manipal University 
Address  SMCPT Sikkim manipal institute of medical science 5th mile Tadong Gangtok

East
SIKKIM
737102
India 
Phone  8967035780  
Fax    
Email  drpriyankampt@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Priyanka Singh 
Designation  Associate professor 
Affiliation  Sikkim Manipal University 
Address  SMCPT Sikkim manipal institute of medical science 5th mile Tadong Gangtok

East
SIKKIM
737102
India 
Phone  8967035780  
Fax    
Email  drpriyankampt@gmail.com  
 
Details of Contact Person
Public Query  
Name  TEHRILILA T SANGTAM  
Designation  postgraduate student 
Affiliation  Sikkim Manipal University 
Address  SMCPT Sikkim manipal institute of medical science 5th mile Tadong Gangtok

East
SIKKIM
737102
India 
Phone  7896280308  
Fax    
Email  arisangtam555@gmail.com  
 
Source of Monetary or Material Support  
SIKKIM manipal college of physiotherapy SMIMS, Sikkim mannipal university, 5th mile , Tadong Gangtok sikkim 
 
Primary Sponsor  
Name  Sikkim Manipal University 
Address  SMIMS 5th mile Tadong, Gangtok, SIKKIM 
Type of Sponsor  Private medical college 
 
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 
priyanka singh  Central referral hospital  Sikkim Manipal college of physiotherapy department of Physiotherapy
East
SIKKIM 		 08967035780
03592-231162
drpriyankampt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMIMS INSTITUTION ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G460||Middle cerebral artery syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional therapy  Convention therapy will be subjects specific, it includes stretching exercise strengthening exercises and weight shifting and various approachesand combination of exercises like MRP, Brunnstorm, Bobath, PNF, NDT 30 min per session 5 days per week for 3 weeks.  
Intervention  trunk exercise  Subjects will receive exercises consisting of upper and lower part of the trunk in supine and sitting. These exercises will be initiated with moderate assistance to obtain proper quality of movement and process to a state of no assistance. The number of repetition and intensity of the exercises will be determined by the tester 1 based on the subjects performance. Adequate rest period of 1-2 minute will givenin between the exercises. Intensity of the exercises will be increase by introducing following changes: 1. reducing the base of support 2. increasing the hold time 3. advancing the balance limits 4. increasing the lever arm  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  first ever medically stable stroke subjects
7 days to 3 months post stroke
both gender of 40 to 70 years
MMSE more than 24
TIS scoring less or equal to 17/21 out of 23
subjects should be able to sit independently for 30 seconds 
 
ExclusionCriteria 
Details  myocardial infarction within the past 6 months
symptomatic coronary artery disease or heart failure
visual or hearing impairment
uncooperative subjects 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Trunk impairment scale
Manual muscle testing
Brunel balance assessment
Modified barthel index 		 it will assess after recruitment of subjects and post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   19/08/2019 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   stroke subjects will be recruited based on inclusion criteria and informed consent form will be taken. primary investigator will take all baseline assessment and pre intervention outcome measures. subjects will be randomized by secondary investigator by lottery method and divided into two group. Group A consist of intervention along with conventional therapy and Group B consist of conventional therapy. intervention will be given by primary investigator who will be blinded to allocation of subjects. both group will receive treatment for 5 days /week for 3 weeks and  after  which post intervention outcome measures will be taken . follow up after 3 months will be done. total duration of the study is of 12 months. 
Close