| 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
|
|
|
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
|
|
|
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.
|