Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000654459
Ethics application status
Approved
Date submitted
12/05/2016
Date registered
19/05/2016
Date last updated
29/11/2019
Date data sharing statement initially provided
29/11/2019
Date results provided
29/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of the BuzzNudge rehabilitation device in increasing daily use of the arm in people with stroke on a rehabilitation ward.
Scientific title
Efficacy of the BuzzNudge 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 over a single 12 hour period. During the observation days some patients will wear devices containing IMU accelerometers.

For the second phase of data collection participants will be assessed using the usual practice on the ward. Participants who consent to the study will be randomised into two groups of 10. Both groups will wear the BuzzNudge haptic reminder bands and up to three other accelerometers. The control group will just wear the bands and in the BuzzNudge group the bands will be set to vibrate approximately every 20 minutes during the day.

Participants in both groups will be shown the nudge reminder bands which contain accelerometers plus up to three other accelerometers. Accelerometers will be unobtrusively attached to participants wrists, upper arm and torso. They will be attached using either watch like wrist bands or hypoallergenic tape. In the instance of the participant having significant hair they will be given the option of shaving for comfort. The participants arm length will be measured with a soft measuring tape to ensure correct positioning of the accelerometers. Education on use of the nudge reminder and measurement of the arms is estimated to take less than 30 minutes. The groups will be introduced to the nudge reminder band by a fourth year physiotherapy student who will explain how the band is used and give them standardised instructions. Participants will be encouraged to wear the BuzzNudge bands and accelerometers during the day. A 4th year physiotherapy student will explain to participants in both groups the value of moving their hemiplegic arm after stroke. Participants in the BuzzNudge group will be asked to interpret the vibration of the band on their hemiplegic wrist as a cue to remind them to use their arm. The 4th year student will encourage the participant to move their arm or attempt to move their arm when they sense the band vibrating. Any movement or attempted movement will be considered of benefit provided it doesn’t cause any pain in the arm or shoulder. A patient’s decision on whether or not to use or respond to the nudge reminder system will have no impact on other treatment decisions made by the therapist. Data will be collected continuously from the accelerometers and also by observation intermittently over a 12 hour period as per the initial data collection.

Intervention code [1] 294730 0
Rehabilitation
Intervention code [2] 294747 0
Treatment: Devices
Comparator / control treatment
Controlled. One group wear the BuzzNudge set to buzz approximately every 20 mins. The control group wear the BuzzNudge without them being set to "buzz".
Control group
Active

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 7pm 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
One day of observation assessment +/- accelerometery assessment as described above will occur after the participant has consented to the study with a further day of observation assessment +/- accelerometry occurring after the participant has been introduced to the BuzzNudge equipment.
Secondary outcome [1] 323729 0
IMU accelerometer data assessing arm movement.
Timepoint [1] 323729 0
One days' accelerometery assessment will occur on some participants after they have consented to the study with a further day accelerometry occurring after they have been introduced to the Buzz Nudge 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
Sex
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2016
Actual
2/08/2016
Date of last participant enrolment
Anticipated
20/12/2016
Actual
21/11/2018
Date of last data collection
Anticipated
Actual
21/11/2018
Sample size
Target
20
Accrual to date
Final
20
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
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
Approved
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
22/06/2016
Ethics approval number [1] 295020 0

Summary
Brief summary
Background
Following stroke around 80% of people are left with reduced function in their arm. Maximising recovery is an ongoing challenge for stroke rehabilitation providers. Research demonstrates that high frequency and intensity of exercise and functional movement has been associated with improved functional outcomes and reduced time in hospital for people with stroke[4]. However, the recommended dose and intensity of rehabilitation in the most effective rehabilitation studies is difficult to implement within the constraints of current models of practice and funding, both in New Zealand and internationally. In fact, the only observational study collecting data on upper limb movement in a rehabilitation setting has demonstrated that very little arm movement occurs over the course of a standard rehabilitation day.

Study Aims
The purpose of this study is to describe the amount of upper limb activity undertaken during an inpatient rehabilitation day for a group of adults experiencing the effects of sub-acute stroke by observational methods and accelerometry. And to observe the effect introducing a wristband that provides a vibrating nudge reminder to use the arm has on levels of upper limb activity over the day.

The following questions will be addressed:
1. Is there an association between data collected by upper limb accelerometers and observational methods of upper limb movement data collection?
2. Does the implementation of the BuzzNudge reminder increase the amount of upper limb activity undertaken by people with stroke in rehabilitation?
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
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
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics does not cover this


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes McLaren R, Signal N, Lord S, Taylor S, Henderson J... [More Details] 370687-(Uploaded-27-11-2019-05-10-58)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHaptic Nudges Increase Affected Upper Limb Movement During Inpatient Stroke Rehabilitation: Multiple-Period Randomized Crossover Study.2020https://dx.doi.org/10.2196/17036
N.B. These documents automatically identified may not have been verified by the study sponsor.