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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
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Scientific title
A multimodal intervention using robotics, electrical stimulation, virtual reality and haptic feedback is stroke upper limb rehabilitation
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Secondary ID [1]
296701
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Nil known
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Universal Trial Number (UTN)
U1111-1221-4899
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Trial acronym
RESERVOIR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stroke
310546
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Condition category
Condition code
Stroke
309258
309258
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0
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Haemorrhagic
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Stroke
309284
309284
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0
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Ischaemic
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
313012
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Treatment: Devices
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Intervention code [2]
313013
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Rehabilitation
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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
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Control group
Active
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Outcomes
Primary outcome [1]
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upper limb motor function assessed with items 5,7 and 7 of the Motor assessment scale(MAS)
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Assessment method [1]
308241
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Timepoint [1]
308241
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end of intervention (3weeks)
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Secondary outcome [1]
354357
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strength: assessed using a grip dynamometer
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Assessment method [1]
354357
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Timepoint [1]
354357
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post intervention (3weeks)
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Secondary outcome [2]
354358
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fatigue: assessed using the Fatigue assessment scale (FAS)
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Assessment method [2]
354358
0
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Timepoint [2]
354358
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post intervention (3weeks)
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Secondary outcome [3]
354359
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health related quality of life: assessed using the SF-8
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Assessment method [3]
354359
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Timepoint [3]
354359
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post intervention (3weeks)
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Secondary outcome [4]
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Attitudes towards the therapy assessed using a questionnaire developed by the research team
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Assessment method [4]
354360
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Timepoint [4]
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post intervention (3weeks)
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Secondary outcome [5]
354361
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mood: assessed using the Hospital Depresssion and Anxiety Scale (HADS)
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Assessment method [5]
354361
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Timepoint [5]
354361
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post intervention (3weeks)
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Secondary outcome [6]
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independance: assessed using the Barthel Index (BI)
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Assessment method [6]
354362
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Timepoint [6]
354362
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post intervention (3weeks)
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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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation sequence created by computer software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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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.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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).
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
18/02/2019
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Actual
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Date of last participant enrolment
Anticipated
4/11/2019
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Actual
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Date of last data collection
Anticipated
24/02/2020
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
12539
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Tamworth Rural Referral Hospital - Tamworth
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Recruitment hospital [2]
12540
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Wyong Public Hospital - Hamlyn Terrace
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Recruitment postcode(s) [1]
24920
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2340 - Tamworth
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Recruitment postcode(s) [2]
24921
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2259 - Hamlyn Terrace
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Funding & Sponsors
Funding source category [1]
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Other Collaborative groups
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Name [1]
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Hunter Medical research Institute
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Address [1]
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Lot 1 Kookaburra Circuit
New Lambton Heights NSW 2305
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Newcastle
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Address
University Drive
Callaghan NSW 2305
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Country
Australia
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Secondary sponsor category [1]
300939
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Other Collaborative groups
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Name [1]
300939
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Hunter Medical Research institute
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Address [1]
300939
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Lot 1 Kookaburra Circuit
New Lambton Heights NSW 2305
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Country [1]
300939
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Australia
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
302024
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Hunter New England Health Research Ethics Committee
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Ethics committee address [1]
302024
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Locked Bag 1,
New Lambton NSW 2305
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Ethics committee country [1]
302024
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Australia
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Date submitted for ethics approval [1]
302024
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30/11/2018
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Approval date [1]
302024
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Ethics approval number [1]
302024
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Summary
Brief summary
Innovative technologies for sensorimotor rehabilitation after acquired brain injury have dramatically increased over the past 20 years and their development, as well as the demand for access to these devices, is expected to continue to increase exponentially. Many of the developments have been technology-driven which may limit their application and acceptance in clinical settings. Emerging research shows promise, and collaborative research with engineers, therapists and end-users is critical for the successful translation of these devices into standard practice. Based on this premise, we aim to examine the potential benefits of using a novel device, which incorporates virtual reality, triggered-electrical stimulation and haptic feedback, as an adjunct therapy for the rehabilitation of people with stroke.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Jodie Marquez
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Address
88874
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University of Newcastle
School of Health Sciences
University Drive,
Callaghan NSW 2305
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Country
88874
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Australia
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Phone
88874
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+61 249212041
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Fax
88874
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Email
88874
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[email protected]
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Contact person for public queries
Name
88875
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Dr Jodie Marquez
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Address
88875
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University of Newcastle
School of Health Sciences
University Drive,
Callaghan NSW 2305
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Country
88875
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Australia
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Phone
88875
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+61 249212041
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Fax
88875
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Email
88875
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[email protected]
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Contact person for scientific queries
Name
88876
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Dr Jodie Marquez
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Address
88876
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University of Newcastle
School of Health Sciences
University Drive,
CallaghanNSW 2305
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Country
88876
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Australia
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Phone
88876
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+61 249212041
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Fax
88876
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Email
88876
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified individual particiant data for each of the outcomes
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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
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Available to whom?
The data will be available upon request, subject to approvals by the principal investigator, based on a defined research proposal
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Available for what types of analyses?
The data will be available for any further research purposes
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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.
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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.
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