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CTRI Number  CTRI/2018/05/013725 [Registered on: 07/05/2018] Trial Registered Prospectively
Last Modified On: 19/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of task oriented trunk training on trunk control and community reintegration in comparison with conventional therapy among acute stroke subjects: a randomized controlled trial 
Scientific Title of Study   Effectiveness of task oriented trunk training on trunk control and community reintegration in comparison with conventional therapy among acute stroke subjects: a randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akshatha Nayak 
Designation  Assistant Professor - Senior Scale 
Affiliation  Kasturba Medical College 
Address  Department of Physiotherapy, Kasturba Medical College, Bejai Campus, Bejai, Mangaluru
C III 17, KMC Staff Quarters, Light House Hill Road, Hamapankatta, Mangaluru - 575001
Dakshina Kannada
KARNATAKA
575003
India 
Phone  9986054034  
Fax    
Email  akshatha.nd@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Akshatha Nayak 
Designation  Assistant Professor - Senior Scale 
Affiliation  Kasturba Medical College 
Address  Department of Physiotherapy, Kasturba Medical College, Bejai Campus, Bejai, Mangaluru
C III 17, KMC Staff Quarters, Light House Hill Road, Hamapankatta, Mangaluru - 575001
Dakshina Kannada
KARNATAKA
575003
India 
Phone  9986054034  
Fax    
Email  akshatha.nd@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Akshatha Nayak 
Designation  Assistant Professor - Senior Scale 
Affiliation  Kasturba Medical College 
Address  Department of Physiotherapy, Kasturba Medical College, Bejai Campus, Bejai, Mangaluru
C III 17, KMC Staff Quarters, Light House Hill Road, Hamapankatta, Mangaluru - 575001

KARNATAKA
575003
India 
Phone  9986054034  
Fax    
Email  akshatha.nd@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Light House Hill Road, Hampankatta, Mangaluru 
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 
Akshatha Nayak  Kasturba Medical College and Hospitals  deparment of Physiotherapy, Kasturba Medical College and hospitals, Mangaluru
Dakshina Kannada
KARNATAKA 		 9986054034

akshatha.nd@manipal.edu 
 
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
Modification(s)  
Health Type  Condition 
Patients  Medically Stable Acute Stroke Subjects, (1) ICD-10 Condition: I693||Sequelae of cerebral infarction, (2) ICD-10 Condition: I69||Sequelae of cerebrovascular disease, (3) ICD-10 Condition: I691||Sequelae of nontraumatic intracerebral hemorrhage, (4) ICD-10 Condition: I690||Sequelae of nontraumatic subarachnoid hemorrhage,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional physiotherapy  conventional physiotherapy comprising of impairment based treatment for upper limb, lower limb of the affected side and trunk. 
Intervention  Task Oriented Trunk Training  task oriented trunk training in addition to conventional physiotherapy (impairment based) to affected side upper and lower limbs 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1)Clinically stable subjects with first episode of supra-tentorial stroke in the acute stage.
2)20 years to 80 years of age.
3)Mini-Mental Scale Examination score of ≥23.
4)Ability to sit for 30 seconds.
5)Trunk impairment Scale score less than 23.
 
 
ExclusionCriteria 
Details  1)Multiple episode of stroke.
2)Neurological disorders other than stroke that could influence balance and ambulation.
3)Subjects with a history of diagnosed musculoskeletal or cardiovascular disorders of the trunk and/or lower extremities who can’t tolerate treatment positions and intensity.
4)Subject having perceptual issues like hemi-neglect, pusher’s syndrome, severe visual field defects and somato-sensory deficit.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1)Trunk Impairment Scale
2)Trunk muscle strength using hand Held Dynamometer
3) RNLI for Community Re-integration 		 pre intervention, 2 weeks post inpatient rehabilitation, 4 weeks post home rehabilitation and 6 moths follow up assessment 
 
Secondary Outcome  
Outcome  TimePoints 
BESTest for balance, ABC for Balance self Efficacy, PALM for pelvic alignment  pre intervention, 2 weeks post inpatient rehabilitation, 4 weeks post home rehabilitation and 6 moths follow up assessment 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
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)   13/05/2018 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Subjects diagnosed with stroke referred to physiotherapy will be approached and informed consent will be collected from them. Upon the consent they will be screened for inclusion and exclusion criteria for eligibility. The eligible subjects will be randomized into two groups i.e. control group and experimental group through block randomization method. after randomization demographic data will be collected and baseline parameters will be assessed using both the primary and secondary outcome measures. Both the groups will get two weeks of hospital based intervention; post which they will get 4 weeks of home exercises.

Control group will receive conventional impairment based rehabilitation for upper limb, lower limb and trunk in hospital based rehabilitation and post discharge they will be asked to continue the same as home program.
Experimental Group will receive conventional impairment based rehabilitation for upper and lower limb; and task oriented training for trunk in hospital based rehabilitation and as same will be continued as home program for 4 weeks. 

 
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