Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001439235p
Ethics application status
Not yet submitted
Date submitted
16/08/2018
Date registered
28/08/2018
Date last updated
28/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
BuzzNudge: Usability of a new device to aid Stroke Rehabilitation
Scientific title
Measuring and promoting everyday activity in Stroke rehabilitation; BuzzNudge Usability Trial
Secondary ID [1] 295825 0
None
Universal Trial Number (UTN)
U1111-1219-0548
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 309265 0
Condition category
Condition code
Stroke 308137 308137 0 0
Haemorrhagic
Stroke 308138 308138 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The BuzzNudge is an accelerometer and vibrating motor mounted in a plastic case attached to the wrist in the style of a wrist watch or fitbit exercise band. It is controlled by an app on a smartphone. The participant will be introduced to the BuzzNudge by either a physiotherapist or a physiotherapy student during a single 90 minute session at AUT. The data collectors have already been trained in this type of data collection as part of another study and will have had time to familiarise themselves with the BuzzNudge with assistance from one of the research team members. It is anticipated that data collector familiarisation with the device will take between 30- 60 minutes. It is likely the participant will wear the BuzzNudge for up to one hour. The focus of the participant will be on the operational (donning and doffing the BuzzNudge, selecting appropriate parameters on the app controller), and aesthetic properties of the device checking on the usability and functionality of the working prototype.

The usability study will use the following data collection tools:
Video observations
Audio recording
Think-aloud protocols
Semi-structured interviews

The video and audio recording will commence once the participant has signed the consent form and continue until the end of the session. The Semi- structured interview will occur in the latter part of the 90 minute session after the participant has had time to familiarise themselves with the BuzzNudge
Intervention code [1] 312157 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307114 0
Qualitative descriptive data from the think-aloud protocol and interviews will be analysed using descriptive content analysis to provide a composite sense of the stroke patients opinions and experience when engaging with the BuzzNudge. This will provide a rich description of participants’ experiences and opinions of the devices usability and acceptability rather than an interpretation. Interviews will be listened to verbatim and then interview transcripts will be read and re-read. Observation notes will be corroborated against the video data. Subsequently transcripts and written observation notes will be imported into NVivo to be coded. A loose coding framework will initially be applied to sentences or phrases. In order to gain an understanding of the relationships among codes, a number of other strategies will be utilised to analyse the data. These include making constant comparison within and across codes and data sources, and the use of memos to record details of the codes and to keep track of initial thoughts about the data and any hypothesised interactions among codes. The coded transcripts will then be sent to a second researcher to ensure consistency of interpretation and meetings will be held to discuss the interpretation of data with the aim of reaching consensus on thematic development. For the purposes of data representation illustrative quotes will be selected that corroborate the data.
Timepoint [1] 307114 0
Audio data will be collected during a single 90 minute session at AUT. During this 90 minute period it is likely they may don and doff the BuzzNudge several times so data will be collected before they use the device, as they are using the device and directly after using the device all within this single 90 minute session.
Primary outcome [2] 307220 0
Qualitative descriptive data from the think-aloud protocol and interviews will be analysed using descriptive content analysis to provide a composite sense of the physiotherapists opinions and experience when engaging with the BuzzNudge. This will provide a rich description of participants’ experiences and opinions of the devices usability and acceptability rather than an interpretation. Interviews will be listened to verbatim and then interview transcripts will be read and re-read. Observation notes will be corroborated against the video data. Subsequently transcripts and written observation notes will be imported into NVivo to be coded. A loose coding framework will initially be applied to sentences or phrases. In order to gain an understanding of the relationships among codes, a number of other strategies will be utilised to analyse the data. These include making constant comparison within and across codes and data sources, and the use of memos to record details of the codes and to keep track of initial thoughts about the data and any hypothesised interactions among codes. The coded transcripts will then be sent to a second researcher to ensure consistency of interpretation and meetings will be held to discuss the interpretation of data with the aim of reaching consensus on thematic development. For the purposes of data representation illustrative quotes will be selected that corroborate the data.
Timepoint [2] 307220 0
Audio data will be collected during a single 90 minute session at AUT. During this 90 minute period it is likely the BuzzNudge will be donned and doffed several times so data will be collected before they use the device, as they are using the device and directly after using the device all within this single 90 minute session.
Secondary outcome [1] 350733 0
The video data will be analysed by task to determine if any particular tasks were systematically problematic. This will provide a composite sense of the participant's abilities during engagement with the BuzzNudge. Descriptive level data will be used to indicate performance across the tasks.
Timepoint [1] 350733 0
Video data will be collected during a single 90 minute session at AUT. During this 90 minute period it is likely they may don and doff the BuzzNudge several times so data will be collected before they use the device, as they are using the device and directly after using the device all within this single 90 minute session.

Eligibility
Key inclusion criteria
Stroke Participants inclusion criteria:
- Age 18 years or older
- People with an onset of stroke more than 6 months prior
- People who have an ongoing upper limb disability as a result of the stroke

Physiotherapist Participants inclusion criteria:
- Stroke rehabilitation experts with at least 5 years professional experience in the field of neurological rehabilitation
- Able to attend a data collection session at AUT
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Stroke Participants exclusion criteria:
- People who in the opinion of the research physiotherapist are unable to participate in the research process due to cognitive, perceptual and/or communication impairments.
- People, who in the opinion of the research physiotherapist are unable to have discussions because of English language limitations.

Physiotherapist Participants exclusion criteria:
Not applicable

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Qualitative descriptive data from the think-aloud protocol and interviews will be analysed using descriptive content analysis. This will provide a rich description of participants’ experiences and opinions of the devices usability and acceptability rather than an interpretation. Interviews will be listened to verbatim and then interview transcripts will be read and re-read. Observation notes will be corroborated against the video data. Subsequently transcripts and written observation notes will be imported into NVivo to be coded. A loose coding framework will initially be applied to sentences or phrases. In order to gain an understanding of the relationships among codes, a number of other strategies will be utilised to analyse the data. These include making constant comparison within and across codes and data sources, and the use of memos to record details of the codes and to keep track of initial thoughts about the data and any hypothesised interactions among codes. The coded transcripts will then be sent to a second researcher to ensure consistency of interpretation and meetings will be held to discuss the interpretation of data with the aim of reaching consensus on thematic development. For the purposes of data representation illustrative quotes will be selected that corroborate the data.

The video data will be analysed by task to determine if any particular tasks were systematically problematic. Descriptive level data will be used to indicate performance across the tasks.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/09/2018
Actual
Date of last participant enrolment
Anticipated
18/03/2019
Actual
Date of last data collection
Anticipated
29/03/2019
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 20781 0
New Zealand
State/province [1] 20781 0
Auckland

Funding & Sponsors
Funding source category [1] 300420 0
University
Name [1] 300420 0
Auckland University of Technology
Country [1] 300420 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
90 Akoranga Dr,
Northcote,
Auckland 0627
Country
New Zealand
Secondary sponsor category [1] 299880 0
None
Name [1] 299880 0
Address [1] 299880 0
Country [1] 299880 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301224 0
HDEC: Northern A Health and Disability Ethics Committee
Ethics committee address [1] 301224 0
Ministry of Health Health and Disability Ethics Committees
PO Box 5013.
Wellington 6140.
Ethics committee country [1] 301224 0
New Zealand
Date submitted for ethics approval [1] 301224 0
31/08/2018
Approval date [1] 301224 0
Ethics approval number [1] 301224 0

Summary
Brief summary
Aim
The function of this research is to evaluate the usability and acceptability of the BuzzNudge for technology assisted stroke rehabilitation.

Background
Stroke is one of the leading causes of disability in the world . Eighty percent of people with stroke experience difficulty moving their arm and hand. Research indicates that higher volumes of rehabilitation and physical activity after stroke promote improved functional outcomes and are associated with reduced length of in- patient stay. Traditional rehabilitation approaches rely upon 1:1 therapy sessions with physiotherapists or occupational therapists aimed at addressing sensorimotor impairments and retraining upper limb function. Yet a recent systematic review highlighted that patients spend as little as 4 minutes per physiotherapy session undertaking upper limb rehabilitation, accounting for just 23-32 arm movement repetitions. Data from our own study at Waitemata District Health Board demonstrates that even when a 12-hour inpatient rehabilitation day is observed, people with stroke move their affected arm for just 12% of the day.
After a number of iterations of the BuzzNudge wearable device and the Smartphone App we have achieved a stable and reliable system that works in the hospital environment.
Since the seed project completion, we have extended this work to a) Explore the impact of vibratory reminders to move the affected arm after stroke using the prototype system in seven people undertaking inpatient rehabilitation . We are now ready to develop the BuzzNudge further looking specifically at usability and acceptability in the populations that will use it, Stroke patients and Physiotherapists.
Specific research questions
1. Is the BuzzNudge an acceptable rehabilitation device for people with stroke in the opinion of stroke rehabilitation experts.

2. Is the BuzzNudge an acceptable rehabilitation device for people with stroke in the opinion of people with stroke?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86290 0
Dr Nada Signal
Address 86290 0
Auckland University of Technology
90 Akoranga Dr,
Northcote,
Auckland 0627
Country 86290 0
New Zealand
Phone 86290 0
+64 21 929144
Fax 86290 0
Email 86290 0
[email protected]
Contact person for public queries
Name 86291 0
Dr Nada Signal
Address 86291 0
Auckland University of Technology
90 Akoranga Dr,
Northcote,
Auckland 0627
Country 86291 0
New Zealand
Phone 86291 0
+64 27 2102683
Fax 86291 0
Email 86291 0
[email protected]
Contact person for scientific queries
Name 86292 0
Dr Nada Signal
Address 86292 0
Auckland University of Technology
90 Akoranga Dr,
Northcote,
Auckland 0627
Country 86292 0
New Zealand
Phone 86292 0
+64 27 2102683
Fax 86292 0
Email 86292 0
[email protected]

No information has been provided regarding IPD availability


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.