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Trial registered on ANZCTR


Registration number
ACTRN12616000654459p
Ethics application status
Not yet submitted
Date submitted
12/05/2016
Date registered
19/05/2016
Date last updated
19/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of the AbleX rehabilitation device in increasing daily use of the arm in people with stroke on a rehabilitation ward.
Scientific title
Efficacy of the AbleX rehabilitation device in increasing daily use of the arm in people with stroke on a rehabilitation ward.
Secondary ID [1] 289199 0
none
Universal Trial Number (UTN)
none
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 298750 0
Condition category
Condition code
Physical Medicine / Rehabilitation 298802 298802 0 0
Physiotherapy
Stroke 298818 298818 0 0
Haemorrhagic
Stroke 298819 298819 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo unobtrusive observations monitoring their upper limb use conducted on 2 consecutive days. During the observation days some patients will wear two watch-like, water-resistant devices containing IMU accelerometers.

In the second part of the study participants will be assessed by a registered physiotherapist trained in the use of the AbleX using the usual practice on the ward. Participants whom the therapists assess as potentially benefiting from the AbleX will will be introduced to the AbleX equipment and taught how to use it. Education on how to use the AbleX is estimated to take less than 1 hour. The AbleX is a virtual reality trainer designed to provide repetitive, intensive, purposeful and engaging active movement of the upper limb in people who have had a stroke. This has been used for independent training to augment conventional clinical rehabilitation. It involves using the versatile hand held AbleX controller designed specifically for people with reduced muscle control and using both arms and one hand to move the controller and manipulate what is happening on a computer game on their desktop or laptop computer. Participants will have an individualised login which will enable them to access a series of virtual reality games that are tailored to their individual rehabilitation goals by the therapist. This access will be for a period of 4 weeks. Participants will be encouraged to access the AbleX equipment independently or with the help of a carer between physiotherapy sessions, in the evenings and on the weekend as much or as little as they choose. Time spent playing the Able X games will be obtained directly the AbleX software on the computer for each participant. Their decision to access or not access the AbleX system will have no impact on other treatment decisions made by the therapist.

Subsequent to being taught how to use the AbleX participants will undergo unobtrusive observations monitoring their upper limb use conducted on 2 consecutive days. During the observation days some patients will wear two watch-like, water-resistant devices containing IMU accelerometers to measure their arm movements. These observation sessions will occur three days or more after the participant has received education on how to use the AbleX to give them time to famillarise themselves with the equipment and trouble shoot any potential problems.
Intervention code [1] 294730 0
Rehabilitation
Intervention code [2] 294747 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298272 0
Following written consent, participants will be introduced to the final year physiotherapy student who will conduct the observation assessment under supervision of a registered physiotherapist. If accelerometers are available participants will also have two accelerometers attached, one on each wrist to capture movement data during the period of data collection. Observations will take place for one minute at 10 minute intervals between 7am and 9pm on two subsequent days. The student physiotherapist will observe each patient on a roster with a maximum of two participants being observed on any one day. 4 randomly scheduled 15 minute breaks will be undertaken by the student. The student physiotherapist will position themselves inconspicuously, ideally out of the field of view of the participant (including outside the door of small rooms) and will follow the participant both inside the rehabilitation ward, therapy areas and hospital facilities for the duration of the observation period. When patients are not able to be directly observed (i.e. due to curtains being drawn or whilst in showers and toilets) activity will be recorded after conferring with the participant, staff or family members. In circumstances were the activity cannot be estimated participants will be classified as unobserved and these episodes excluded from analysis. Observations will be recorded using a taxonomy of observation. All upper-limb movements will be recorded. At the end of the day accelerometer data will be downloaded from the accelerometers and loaded into a file under the study number for that participant.
Timepoint [1] 298272 0
Two days of observation assessment +/- accelerometery assessment as described above will occur after the participant has consented to the study with a further two days of observation assessment +/- accelerometry occurring at greater than three days after the participant has been introduced to the AbleX equipment.
Secondary outcome [1] 323729 0
IMU accelerometer data assessing arm movement.
Timepoint [1] 323729 0
Two days accelerometery assessment will occur on some participants after they have consented to the study with a further two days accelerometry occurring for some participants at greater than three days after they have been introduced to the AbleX equipment.

Eligibility
Key inclusion criteria
1. Inpatient on Murawai Ward or Wainamu Ward, Waitakere hospital, Auckland, at the time of study
2. Adult over 17 years
3. Diagnosis of Stroke
4. Determined medically stable and fit for rehabilitation by a Medical Consultant.
Minimum age
17 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. ndividiuals considered medically unstable for active rehabilitation in the opinion of the Rehabilitation Ward Medical Consultant, Waitakere Hospital.
2. Individuals with cognitive, behavioural and/ or communication impairment that in the opinion of the research team means that participating in the study would add significantly to the persons burden.
3. Individuals who are within 3 days of planned discharge from inpatient rehabilitation.
4. Individuals unable to provide written consent and a relative of other person is unavailable to provide consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7872 0
New Zealand
State/province [1] 7872 0
Auckland

Funding & Sponsors
Funding source category [1] 293573 0
University
Name [1] 293573 0
Auckland University of Technology
Address [1] 293573 0
90 Akoranga Drive
Northcote,
Auckland
1142
Country [1] 293573 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
90 Akoranga Drive
Northcote,
Auckland
1142
Country
New Zealand
Secondary sponsor category [1] 292394 0
None
Name [1] 292394 0
Address [1] 292394 0
Country [1] 292394 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 295020 0
HDEC
Ethics committee address [1] 295020 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Thorndon
Wellington 6011
Ethics committee country [1] 295020 0
New Zealand
Date submitted for ethics approval [1] 295020 0
31/05/2016
Approval date [1] 295020 0
Ethics approval number [1] 295020 0

Summary
Brief summary
Following stroke a large proportion of people are left with reduced function in their arm. It is estimated that only between 5- 20% of stroke patients recover full arm function after stroke. Maximising patient recovery is an ongoing challenge for stroke rehabilitation providers. A high frequency and intensity of exercise has been associated with improved functional outcomes and reduced time in hospital for people with stroke. However, several studies investigating arm usage found that in a sub- acute rehabilitation setting there is very little arm movement over the course of the day. We propose to use observational methods to discover how much upper limb use occurs on a rehab ward over a day. We will then introduce the AbleX, a virtual reality upper limb trainer as a resource on the ward. Technology-assisted upper-limb training after stroke is thought to provide engaging and task-oriented training to support the retraining of motor skills. The AbleX can be used independently by patients on the ward giving them increased opportunity and motivation for functional arm movement. We will then repeat the observational study to investigate whether there is a change in the amount of use of the upper limb subsequent to individuals having access to the AbleX technology.

Scientific basis of this study:
Increased duration and intensity of purposeful activity in sub- acute rehabilitation settings are thought to result in improved outcomes for people with stroke. However, current models of both rehabilitation therapy provision and funding do not facilitate the levels of activity that have proved effective in research.

The AbleX is a virtual reality trainer designed to provide repetitive, intensive, purposeful and engaging active movement of the upper limb in people who have had a stroke. This can be used for independent training to augment conventional clinical rehabilitation and requires minimal ongoing therapist time. Evidence to date suggests that video games are a safe and independent method of eliciting more purposeful repetitions of the upper limb and higher acceleration of movement compared with traditional therapy in individuals with stroke. Users have also found them enjoyable and they have engaged users for a duration considered necessary for effective rehabilitation.

Evidence of improved levels of functional movement would offer a strong argument that AbleX enhances rehabilitation outcomes.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 65806 0
Mrs Ruth McLaren
Address 65806 0
Auckland University of Technology
Health and Rehabilitation Research Institute
Private Bag 92006
Auckland 1142
Country 65806 0
New Zealand
Phone 65806 0
+64 272102683
Fax 65806 0
Email 65806 0
ruth.mclaren@aut.ac.nz
Contact person for public queries
Name 65807 0
Mrs Ruth McLaren
Address 65807 0
Auckland University of Technology
Health and Rehabilitation Research Institute
Private Bag 92006
Auckland 1142
Country 65807 0
New Zealand
Phone 65807 0
+64272102683
Fax 65807 0
Email 65807 0
ruth.mclaren@aut.ac.nz
Contact person for scientific queries
Name 65808 0
Mrs Ruth McLaren
Address 65808 0
Auckland University of Technology
Health and Rehabilitation Research Institute
Private Bag 92006
Auckland 1142
Country 65808 0
New Zealand
Phone 65808 0
+64 272102683
Fax 65808 0
Email 65808 0
ruth.mclaren@aut.ac.nz

No information has been provided regarding IPD availability
Summary results
No Results