Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001688178
Ethics application status
Approved
Date submitted
24/09/2019
Date registered
2/12/2019
Date last updated
2/12/2019
Date data sharing statement initially provided
2/12/2019
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
None
Universal Trial Number (UTN)
Trial acronym
SRT
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
Haemorrhagic
Stroke 312909 312909 0 0
Ischaemic
Physical Medicine / Rehabilitation 312910 312910 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
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
Rehabilitation
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
Active

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Parallel
Other design features
Phase
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
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/09/2019
Date of last participant enrolment
Anticipated
30/11/2019
Actual
Date of last data collection
Anticipated
14/12/2019
Actual
Sample size
Target
50
Accrual to date
46
Final
Recruitment outside Australia
Country [1] 21884 0
Pakistan
State/province [1] 21884 0
Islamabad Capital Territory

Funding & Sponsors
Funding source category [1] 303903 0
Hospital
Name [1] 303903 0
Shifa International Hospital
Country [1] 303903 0
Pakistan
Primary sponsor type
Individual
Name
Nasir Sultan
Address
Rehabilitation Department, Shifa international Hospital, H8/4, Islamabad
Country
Pakistan
Secondary sponsor category [1] 304051 0
Individual
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
Pakistan

Ethics approval
Ethics application status
Approved
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
Pakistan
Date submitted for ethics approval [1] 304409 0
12/06/2019
Approval date [1] 304409 0
04/07/2019
Ethics approval number [1] 304409 0
IRB# 169-659-2019

Summary
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
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 96850 0
Mr Nasir Sultan
Address 96850 0
Rehabilitation Department, Shifa International Hospital, H-8/4, Islamabad
Country 96850 0
Pakistan
Phone 96850 0
+92 321 9804117
Fax 96850 0
Email 96850 0
[email protected]
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
Pakistan
Phone 96851 0
+92 333 5993417
Fax 96851 0
Email 96851 0
[email protected]
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
Pakistan
Phone 96852 0
+92 333 5993417
Fax 96852 0
Email 96852 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
Email: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.