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CTRI Number  CTRI/2015/03/005654 [Registered on: 25/03/2015] Trial Registered Retrospectively
Last Modified On: 18/03/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   virtual reality/video game training in stroke  
Scientific Title of Study   Effect of Kinect based training on trunk control in patients with stroke 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  QUADROS XINA HENRY 
Designation  POSTGRADUATE-MPT 2ND YEAR 
Affiliation  School of Allied Health Sciences 
Address  DEPARTMENT OF PHYSIOTHERAPY, School of Allied Health Sciences, Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9620134544  
Fax    
Email  xinachris@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr John Solomon 
Designation  Associate Professor 
Affiliation  School of Allied Health Sciences 
Address  DEPARTMENT OF PHYSIOTHERAPY, School of Allied Health Sciences, Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone  09945670671  
Fax    
Email  johnsolomon78@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  QUADROS XINA HENRY 
Designation  POSTGRADUATE-MPT 2ND YEAR 
Affiliation  School of Allied Health Sciences 
Address  DEPARTMENT OF PHYSIOTHERAPY, School of Allied Health Sciences, Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9620134544  
Fax    
Email  xinachris@yahoo.com  
 
Source of Monetary or Material Support  
School Of Allied Health Sciences, Manipal University, Manipal 
 
Primary Sponsor  
Name  School Of Allied Health Sciences 
Address  Deparment of Physiotherapy, SOAHS, Manipal 
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 
Quadros Xina Henry  Kasturba Hospital, manipal  Department of Physiotherapy, SOAHS, Manipal university, manipal
Udupi
KARNATAKA 
9620134544

xinachris@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Kasturba Hospital, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  stroke,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional training  trunk exercises with computer based training for 6 sessions for 1 week 
Intervention  kinect trunk training  jintronix rehabilitation system with trunk exercises for 6 sessions for one week 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with episode of acute/subacute stroke
Patients with MMSE score of >28 out of 30
TIS total score of <21 out of 23
static sitting for 10seconds and those who are able to sit for at least 1min(minimum time to play the game)
 
 
ExclusionCriteria 
Details  Cognitive, visual and/or hearing impairments
Medically unstable
Pre-existing neurologic disorders which could cause motor deficits in addition to those resulting from recent stroke
Orthopaedic disorders
Vestibular disorders
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
trunk impairment scale  pre intervention
post intervention after one week 
 
Secondary Outcome  
Outcome  TimePoints 
motor assessment scale  pre intervention
post intervention after one week 
sit and reach test  pre intervention
post intervention after one week 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   17/02/2014 
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)  Closed to Recruitment of Participants 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Background: In stroke, the trunk muscle weakness can interfere with balance and stability, which may reduce the functional ability .Trunk training, becomes important in early stages of stroke rehabilitation which requires activities to be repetitive and task-oriented and includes active participation of the patient. Virtual reality training has gained widespread application in stroke rehabilitation however use of such technology for improving trunk control has not been explored.

Objective:

To examine the effect of Kinect based trunk training in patients with stroke on trunk control, dynamic balance in sitting and function

Methods:

26 patients with trunk impairments were recruited .Using block randomization, 13 patients were assigned to experimental group and 13 patients to control group. Both groups received conventional physical therapy for six sessions. In addition, the control group received computer based gaming along with upper limb activity with mouse for thirty minutes while the experimental group received  Kinect based trunk training using the Jintronix Rehabilitation System for thirty minutes. At the baseline (pre) and post intervention, following outcome measures: Trunk impairment scale (scores), Motor Assessment Scale (scores), Sit and reach test (distance in cms), were administered and documented by blinded rater.

Results: All the three outcome measures showed a significant difference between both groups with greater improvement in experimental group (p<0.5)  i.e. TIS score(p=0.001), MAS score(p=0.037) and SRT distance(p=0.01)

Conclusion: Kinect based virtual reality training can be incorporated in early stroke rehabilitation to improve trunk control and sitting function.

 

 
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