Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000745347
Ethics application status
Approved
Date submitted
10/05/2017
Date registered
22/05/2017
Date last updated
26/06/2019
Date data sharing statement initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Interactive Virtual Therapy for community-dwelling Stroke survivors
Scientific title
Efficacy of an innovative STRoke Interactive Virtual thErapy (STRIVE) online platform for community-dwelling stroke survivors: a randomised controlled trial protocol.
Secondary ID [1] 291903 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 303209 0
loss of arm function 303370 0
Condition category
Condition code
Stroke 302639 302639 0 0
Haemorrhagic
Stroke 302642 302642 0 0
Ischaemic
Physical Medicine / Rehabilitation 302682 302682 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be participation in interactive computer based activities using the kinect camera and software designed for stroke rehabilitation (JRS wave technology). Participants will view screen based activities and perform tasks that give feedback on arm and body position in space. Between 3 and 5 upper limb exercises will be performed which are functional upper limb tasks that require shoulder flexion, abduction and adduction with elbow flexion, extension and forearm supination. the dose will be for up to 50 minutes twice per week in a community setting for 8 weeks. Sessions will be supervised by an exercise physiologist 1:1 face to face and attendance recorded. The software records duration and number of activities participated in.
Intervention code [1] 298025 0
Rehabilitation
Intervention code [2] 298051 0
Treatment: Devices
Comparator / control treatment
The control group will be instructed to go about their normal daily activities and comply with their scheduled treatment plans. The control group participants will only be required to attend the testing sessions (at baseline and after 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 302054 0
The primary outcome of upper limb function will be measured using composite scores
1.The Fugl-Meyer Upper Extremity (FMUE) scale,
2. Upper limb spasticity as measured by the Modified Ashworth Scale
3.Motor Activity Log-28 (MAL-28) for daily arm use
Timepoint [1] 302054 0
Baseline and at 8 weeks
Primary outcome [2] 302089 0
Stroke-Specific Quality-of-Life (SS-QoL) scale to measure the impact of reduced arm use.
Timepoint [2] 302089 0
Baseline and at 8 weeks
Secondary outcome [1] 334633 0
Changes in cortical activation during motor tasks by functional near-infrared spectroscopy (fNIRS)
Timepoint [1] 334633 0
Baseline and at 8 weeks

Eligibility
Key inclusion criteria
Participants will be included if they are 1) community dwelling stroke survivors, 2) with mild-to-moderate upper arm impairments (Fugl-Meyer upper extremity score 25-45), 3) no cognitive impairments (Mini-mental state examination score >24) and 4) able to read English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Stroke survivors with 1) other neurological conditions (e.g. Parkinson’s disease or dementias) and 2) no observable movements in shoulders or elbows will be excluded from this trial.


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group Allocation will be concealed by the use of opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following study enrolment and completion of the baseline testing, participants will be randomized into a virtual therapy intervention (VT) or control (usual care; UC) group using a computerised random sequence generator, using a block randomisation design (according to location) and stratified by gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed factorial analysis of variance (ANOVA) will be used to determine difference in clinical and neurophysiological measures across GROUP (VT vs. Control) and TIME (PRE- vs. POST-INTERVENTION). Bonferroni post-hoc t-tests for multiple comparisons will be used to determine where significance has occurred. Significance will be set P<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2017
Actual
1/08/2017
Date of last participant enrolment
Anticipated
1/01/2018
Actual
29/06/2018
Date of last data collection
Anticipated
30/03/2018
Actual
29/08/2018
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 296411 0
Charities/Societies/Foundations
Name [1] 296411 0
Heart Foundation Australila
Country [1] 296411 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Burwood Campus
221 Burwood Highway
Burwood, Victoria, 3125
Country
Australia
Secondary sponsor category [1] 295353 0
None
Name [1] 295353 0
Address [1] 295353 0
Country [1] 295353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297635 0
Deakin University Research Ethics Commiteee
Ethics committee address [1] 297635 0
221 Burwood Highway
Burwood, Victoria, 3125
Ethics committee country [1] 297635 0
Australia
Date submitted for ethics approval [1] 297635 0
Approval date [1] 297635 0
09/05/2017
Ethics approval number [1] 297635 0
2017-087

Summary
Brief summary
Introduction: The STRoke Interactive Virtual thErapy (STRIVE) intervention provides community-dwelling stroke survivors access to individualised, remotely-supervised progressive exercises via an online platform. This trial aims to determine the clinical efficacy, effects on brain activity and user preferences of the STRIVE intervention in community-dwelling stroke survivors.
Methods and analysis: In a multi-site, assessor blinded randomised controlled trial with a parallel mixed-methods implementation evaluation, 60 participants from 3 stroke support groups across Victoria and Tasmania will be equally randomised by location to receive 8 weeks of virtual therapy (VT) at a local community centre, or usual care. Participants allocated to VT will perform 3-5 upper-limb exercises (depending on initial impairment severity), whilst participants allocated to usual care will be asked to maintain their daily activities. The primary outcome measure will be upper extremity function and spasticity, as measured by the Fugl-Meyer upper extremity assessment and modified Ashworth scale respectively. Secondary outcome measures include task-related changes in bilateral sensorimotor cortex hemodynamics during hand reaching and wrist extension movements as measured by functional near-infrared spectroscopy. All measures will be assessed at baseline and immediately post-intervention.
Trial website
nil
Trial related presentations / publications
Innovative STRoke Interactive Virtual thErapy (STRIVE) online platform for community-dwelling stroke survivors: a randomised controlled trial protocol
L Johnson, ML Bird, M Muthalib, WP Teo - BMJ open, 2018
Public notes
nil

Contacts
Principal investigator
Name 74666 0
Dr Wei-Peng Teo
Address 74666 0
Faculty of Health
Deakin University
221 Burwood Highway
Burwood, Victoria, 3125
Country 74666 0
Australia
Phone 74666 0
+61 3 9244 5229
Fax 74666 0
Email 74666 0
[email protected]
Contact person for public queries
Name 74667 0
Wei-Peng Teo
Address 74667 0
Faculty of Health
Deakin University
221 Burwood Highway
Burwood, Victoria, 3125
Country 74667 0
Australia
Phone 74667 0
+61 3 9244 5229
Fax 74667 0
Email 74667 0
[email protected]
Contact person for scientific queries
Name 74668 0
Wei-Peng Teo
Address 74668 0
Faculty of Health
Deakin University
221 Burwood Highway
Burwood, Victoria, 3125
Country 74668 0
Australia
Phone 74668 0
+61 3 9244 5229
Fax 74668 0
Email 74668 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2507Study protocolInnovative STRoke Interactive Virtual thErapy (STRIVE) online platform for community-dwelling stroke survivors: a randomised controlled trial protocol L Johnson, ML Bird, M Muthalib, WP Teo - BMJ open, 2018https://bmjopen.bmj.com/content/8/1/e018388.abstract  372902-(Uploaded-25-06-2019-14-24-18)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInnovative Stroke Interactive Virtual Therapy (STRIVE) online platform for community-dwelling stroke survivors: A randomised controlled trial protocol.2018https://dx.doi.org/10.1136/bmjopen-2017-018388
N.B. These documents automatically identified may not have been verified by the study sponsor.