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Trial registered on ANZCTR


Registration number
ACTRN12618001928202p
Ethics application status
Not yet submitted
Date submitted
25/11/2018
Date registered
28/11/2018
Date last updated
28/11/2018
Date data sharing statement initially provided
28/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Arm rehabilitation after stroke using a multimodal device
Scientific title
A multimodal intervention using robotics, electrical stimulation, virtual reality and haptic feedback is stroke upper limb rehabilitation
Secondary ID [1] 296701 0
Nil known
Universal Trial Number (UTN)
U1111-1221-4899
Trial acronym
RESERVOIR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 310546 0
Condition category
Condition code
Stroke 309258 309258 0 0
Haemorrhagic
Stroke 309284 309284 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both groups will receive routine therapy, daily for 60 minutes. For the intervention group, the last 20minutes of this session will be facilitated by the multimodal therapy device. This sophisticated device is the first 'closed loop' see, feel and move rehabilitation system. It incorporates the latest VR and haptic technologies in combination with intelligent muscle stimulation. It is comprised of a glove worn on the affected limb, a VR headset, and a laptop computer which provides the interface to real world environments and daily activities. It allows the patient to practice repetitive, goal directed everyday tasks, in a virtual environment, which are facilitated by the electrical stimulation provided robotic glove. Examples of these activities include picking up a cup, folding a towel and brushing your teeth.The stimulation is triggered in response to both the position of the limb and through the patients’ own EMG signals detected by the glove. This therapy will be provided by the treating therapist (OT or physio) daily for three weeks or until discharge
Intervention code [1] 313012 0
Treatment: Devices
Intervention code [2] 313013 0
Rehabilitation
Comparator / control treatment
The control group will receive routine upper limb therapy as is usual practice in the inpatient rehabilitation setting. This s individualised therapy prescribed by the treating therapist and may be comprised of strengthening, stretching, part-practice and functional activity tasks
Control group
Active

Outcomes
Primary outcome [1] 308241 0
upper limb motor function assessed with items 5,7 and 7 of the Motor assessment scale(MAS)
Timepoint [1] 308241 0
end of intervention (3weeks)
Secondary outcome [1] 354357 0
strength: assessed using a grip dynamometer
Timepoint [1] 354357 0
post intervention (3weeks)
Secondary outcome [2] 354358 0
fatigue: assessed using the Fatigue assessment scale (FAS)
Timepoint [2] 354358 0
post intervention (3weeks)
Secondary outcome [3] 354359 0
health related quality of life: assessed using the SF-8
Timepoint [3] 354359 0
post intervention (3weeks)
Secondary outcome [4] 354360 0
Attitudes towards the therapy assessed using a questionnaire developed by the research team
Timepoint [4] 354360 0
post intervention (3weeks)
Secondary outcome [5] 354361 0
mood: assessed using the Hospital Depresssion and Anxiety Scale (HADS)
Timepoint [5] 354361 0
post intervention (3weeks)
Secondary outcome [6] 354362 0
independance: assessed using the Barthel Index (BI)
Timepoint [6] 354362 0
post intervention (3weeks)

Eligibility
Key inclusion criteria
1. 18 years of age or older
2. Diagnosis of ischaemic or haemorhhagic stroke
3. Admitted to a research site for inpatient rehabilitation
4. Within 2 months of stroke onset
5. Medical stable and able to participate in rehabilitation activities
6. Upper limb impairment: Score less atleast 3 or greater on arm item of MAS ( item 5) ( in supine able to hold arm in elevation and take hand to touch forehead then extend elbow) and 1 or greater on the hand item of MAS (item 6) (extend wrist with forearm supported on a table)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Bilateral impairment
2. Motion sickness
3. Significant cognitive impairment (Montreal Cognitive Assessment Score of <19)
4. Presence of pain or joint restriction that limits the ability to perform upper limb
activities
5. Any medical condition which limits the ability to maintain a sitting posture and participate in the prescribed activities such as severe visual loss, perceptual impairments or dizziness

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)
Allocation will be concealed and will involve the treating therapist contacting the chief investigator by phone at the University of Newcastle for the allocation assignment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation sequence created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
At the end of the treatment phase, those allocated to the control group will have the option of receiving the intervention as an outpatient, 12 weeks post stroke.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics, including means and standard deviations (SD), will be calculated for demographic and outcome data. Change scores for each outcome from baseline will be tested using independent t tests for continuous variables and chi squared tests for categorical variables. Differences from, baseline, post intervention and 12-week follow up as well as between group differences will be evaluated for statistical significance for each outcome. All analyses will be conducted on an intention-to-treat basis, with missing follow-up data conservatively imputed using the last observation carried forward method.
Data collected directly from the device will include EMG data, kinematic data, and electrical stimulation provided, as well as data regarding the dosage of therapy (repetitions, tasks completed, progressions etc). This prospective, daily repeated measures data will be analysed using time-series analysis. All statistical analysis will be performed by a qualified statistician employed by the Hunter Medical Research Institute (HMRI).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/02/2019
Actual
Date of last participant enrolment
Anticipated
4/11/2019
Actual
Date of last data collection
Anticipated
24/02/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12539 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [2] 12540 0
Wyong Public Hospital - Hamlyn Terrace
Recruitment postcode(s) [1] 24920 0
2340 - Tamworth
Recruitment postcode(s) [2] 24921 0
2259 - Hamlyn Terrace

Funding & Sponsors
Funding source category [1] 301280 0
Other Collaborative groups
Name [1] 301280 0
Hunter Medical research Institute
Country [1] 301280 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2305
Country
Australia
Secondary sponsor category [1] 300939 0
Other Collaborative groups
Name [1] 300939 0
Hunter Medical Research institute
Address [1] 300939 0
Lot 1 Kookaburra Circuit
New Lambton Heights NSW 2305
Country [1] 300939 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302024 0
Hunter New England Health Research Ethics Committee
Ethics committee address [1] 302024 0
Ethics committee country [1] 302024 0
Australia
Date submitted for ethics approval [1] 302024 0
30/11/2018
Approval date [1] 302024 0
Ethics approval number [1] 302024 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88874 0
Dr Jodie Marquez
Address 88874 0
University of Newcastle
School of Health Sciences
University Drive,
Callaghan NSW 2305
Country 88874 0
Australia
Phone 88874 0
+61 249212041
Fax 88874 0
Email 88874 0
jodie.marquez@newcastle.edu.au
Contact person for public queries
Name 88875 0
Jodie Marquez
Address 88875 0
University of Newcastle
School of Health Sciences
University Drive,
Callaghan NSW 2305
Country 88875 0
Australia
Phone 88875 0
+61 249212041
Fax 88875 0
Email 88875 0
jodie.marquez@newcastle.edu.au
Contact person for scientific queries
Name 88876 0
Jodie Marquez
Address 88876 0
University of Newcastle
School of Health Sciences
University Drive,
CallaghanNSW 2305
Country 88876 0
Australia
Phone 88876 0
+61 249212041
Fax 88876 0
Email 88876 0
jodie.marquez@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual particiant data for each of the outcomes
When will data be available (start and end dates)?
Data will be available immediately after the first publication and for 5 years after the final data collection of the final participant
Available to whom?
The data will be available upon request, subject to approvals by the principal investigator, based on a defined research proposal
Available for what types of analyses?
The data will be available for any further research purposes
How or where can data be obtained?
Data will be made available upon request, subject to approvals by Principal Investigator and understanding of ethical requirements for data management and disposal.


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.