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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Retrospectively registered

Titles & IDs
Public title
Virtual reality based training for subjects with stroke
Scientific title
Virtual reality training using X-Box Kinect in stroke subjects
Secondary ID [1] 299394 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 314567 0
Balance 314568 0
Functional independence 314569 0
Reduced Mobility 314570 0
Risk of fall 314571 0
Condition category
Condition code
Stroke 312908 312908 0 0
Stroke 312909 312909 0 0
Physical Medicine / Rehabilitation 312910 312910 0 0

Study type
Description of intervention(s) / exposure
X-Box Kinect training for 30 minutes, three times a week for 8 weeks. The participants will play X-Box Kinect based games under supervision of qualified physiotherapist. X-Box kinect comes with a body motion sensor and allows the subject to play games and do exercises in virtual environment. The subjects would be reminded to come for their session via text messages.
Intervention code [1] 315649 0
Comparator / control treatment
Balance training exercises: Tandem walk, high step walk, walking sideways, walking with alternate arm raise (Each with 10-15 steps in every session, having 3 sessions a week for 8 weeks)

Upper limb strengthening exercises: Straight push, circle movements, punching movement, pushing, unweighted and weighted bicep curls,side arm raise, overhead press. (Each with 10-12 repetitions with 2-3 minutes rest time between exercises to avoid fatigue in one session, 3 sessions will be given in a week for 8 weeks))

Core strengthening exercises: Trunk rotations, trunk lateral flexion, leg rotations, leg raise, bridges, crunches, knee to chest, Toe taps. (Each with 10-12 repetitions with 2-3 minutes rest time between exercises to avoid fatigue in one sessions, 3 sessions per week will be given for 8 weeks)
The interventions would be provided by qualified physiotherapist in safe environment.
Control group

Primary outcome [1] 321507 0
Balance by using Berg Balance Scale
Timepoint [1] 321507 0
Before receiving intervention and after 8 weeks of commencement of intervention
Primary outcome [2] 321513 0
Fall risk assessment by using Morse fall assessment scale
Timepoint [2] 321513 0
Before starting intervention and after 8 weeks of commencement of intervention
Primary outcome [3] 321514 0
Functional independence by functional independence measure
Timepoint [3] 321514 0
Before starting intervention and after 8 weeks of commencement of intervention
Secondary outcome [1] 375195 0
Mobility level by using timed up and go test
Timepoint [1] 375195 0
Before starting the intervention and after 8 weeks of commencement of intervention

Key inclusion criteria
Vitally stable subjects who suffered stroke at least 3 months ago, with mild to moderately affected upper limb functions,
Berg balance score 21-40 and independent standing for at least 10 seconds.
Minimum age
45 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Subjects undergone any surgical procedures and suffering from other systemic diseases.
Presence of synergy patterns

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using sealed opaque envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Data will be analysed by SPSS 21, parametric and non parametric tests would be used accordingly to get the results

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 21884 0
State/province [1] 21884 0
Islamabad Capital Territory

Funding & Sponsors
Funding source category [1] 303903 0
Name [1] 303903 0
Shifa International Hospital
Address [1] 303903 0
Rehabilitation department, Shifa International Hospital, H8/4 Islamabad
Country [1] 303903 0
Primary sponsor type
Nasir Sultan
Rehabilitation Department, Shifa international Hospital, H8/4, Islamabad
Secondary sponsor category [1] 304051 0
Name [1] 304051 0
Kiran Khushnood
Address [1] 304051 0
Department of Physical Therapy, Shifa Tameer-e-Millat University, H8/4 Islamabad
Country [1] 304051 0

Ethics approval
Ethics application status
Ethics committee name [1] 304409 0
Institutional Review Board and Ethics Committee, Shifa International Hospital
Ethics committee address [1] 304409 0
Shifa International Hospital, H-8/ 4, Islamabad
Ethics committee country [1] 304409 0
Date submitted for ethics approval [1] 304409 0
Approval date [1] 304409 0
Ethics approval number [1] 304409 0
IRB# 169-659-2019

Brief summary
Stroke is one of the leading pathology that has high morbidity and mortality and is more prevalent in developing countries. Several intervention strategies have been and are being used to counter the symptoms and complications of stroke. Virtual reality is the trend for the era of rehabilitation and has been experimented a lot upon since last decade. Evidences have also shown its positive effects on stroke subjects. Effects and duration for outcome depends upon the type of device used and frequency of usage. Upper limb functions and balance can be improved by virtual reality in stroke patients. Xbox Kinect is a virtual reality device that can be used to improve physical activity along with whole body movements in stroke subjects. Evidence supports use of Xbox Kinect for improving postural control and balance in stroke patients. The proposed study would use Xbox Kinect to improve functional independence, balance, mobility and to reduce risk of fall in subjects with stroke.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 96850 0
Mr Nasir Sultan
Address 96850 0
Rehabilitation Department, Shifa International Hospital, H-8/4, Islamabad
Country 96850 0
Phone 96850 0
+92 321 9804117
Fax 96850 0
Email 96850 0
Contact person for public queries
Name 96851 0
Miss Kiran Khushnood
Address 96851 0
Department of Physical Therapy, Shifa Tameer-e-Millat University, H-8/1, Islamabad
Country 96851 0
Phone 96851 0
+92 333 5993417
Fax 96851 0
Email 96851 0
Contact person for scientific queries
Name 96852 0
Miss Kiran Khushnood
Address 96852 0
Department of Physical Therapy, Shifa Tameer-e-Millat University, H-8/1, Islamabad
Country 96852 0
Phone 96852 0
+92 333 5993417
Fax 96852 0
Email 96852 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication with no end date
Available to whom?
Healthcare professionals, students and organizations working on stroke and it's rehabilitation
Researchers working on stroke rehabilitation
Available for what types of analyses?
IPD meta-analysis
How or where can data be obtained?
access subject to approvals by Principal Investigator
What supporting documents are/will be available?
No other documents available
Summary results
No Results