Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001527358
Ethics application status
Approved
Date submitted
26/10/2017
Date registered
3/11/2017
Date last updated
3/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of exciteBCI for technology assisted stroke rehabilitation: Usability and
acceptability for physiotherapists and people with stroke.
Scientific title
Use of exciteBCI for technology assisted stroke rehabilitation: Usability and
acceptability for physiotherapists and people with stroke.
Secondary ID [1] 293202 0
Nil known
Universal Trial Number (UTN)
U1111-1204-1845
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 305203 0
Condition category
Condition code
Stroke 304516 304516 0 0
Ischaemic
Stroke 304517 304517 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 304522 304522 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
exciteBCI is a wearable rehabilitation device that is novel paired associative stimulation intervention that utilises a brain computer interface (BCI) that aims to promote neural plasticity and improve walking ability in people with stroke. The exciteBCI device augments standard rehabilitation programme. Participants wear an electroencephalography headset and an electrical muscle stimulator over the dorsiflexor or plantar flexor muscles of the ankle, or the quadriceps or hamstring muscles of the thigh depending on the nature of the task and which muscles are prime movers for the task. An application on an ipad controls the device and provides a muscle stimulation timed with the intention to move.
Part one of study: Participants are asked to attend one 90 minute session to explore the usability and acceptability of exciteBCI. Potential users of the exciteBCI will be asked to perform a number of tasks using the exciteBCI whilst engaging in a ‘think-aloud’ process. This involves verbalising their thinking, observations and opinions whilst interacting with the exciteBCI. During the session observational and video recordings are made. The participants also take part in a short semi structured interview after the usability trial. The researcher will ask questions regarding the tasks, design features, pros and cons, and suggested improvements.
Part two of study: Intervention. Following the incorporation of usability feedback two participants with stroke will volunteer to participate in a standard rehabilitation programme augmented by the exciteBCI. The rehabilitation programme will be based on current evidence based practice as recommended in the NZ stroke guidelines and will include task specific training of locomotor skills supervised by a New Zealand registered physiotherapist with clinical experience in stroke rehabilitation. The task specific training will involve an increase in the task complexity over the eight 1-hour sessions over a 3-week period based on principles of motor learning. The rehabilitation workload will be progressed based on the perceived difficulty of each task. The participant will use the exciteBCI throughout the rehabilitation programme. The rehabilitation sessions will be video recorded. Following completion of the rehabilitation programme the person with stroke and the physiotherapist will take part in separate 60-90 minute semi-structured interviews. The rehabilitation programme and interviews will be carried out at AUT University.
Intervention code [1] 299456 0
Rehabilitation
Intervention code [2] 299464 0
Treatment: Devices
Intervention code [3] 299465 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303758 0
Functional measurement: Change in walking speed - 10 metre walk test
Timepoint [1] 303758 0
Pre intervention and 3 days post completion of the 3-week intervention
Primary outcome [2] 303761 0
Functional measurement: Change in walking endurance - Six minute walk test
Timepoint [2] 303761 0
Pre intervention and 3 days post completion of the 3-week intervention
Primary outcome [3] 303763 0
Functional measurement: Sit to stand spped - Change in Chair stand Test
Timepoint [3] 303763 0
Pre intervention and 3 days post completion of the 3-week intervention
Secondary outcome [1] 340096 0
Dynamic balance measurement: Change in 4 Square Step Test
Timepoint [1] 340096 0
Pre intervention and 3 days post completion of the 3-week intervention
Secondary outcome [2] 340098 0
Strength Measurement: Changes in maximum voluntary contraction of the ankle dorsiflexors, using a force gage.
Timepoint [2] 340098 0
Pre intervention and 3 days post completion of the 3-week intervention
Secondary outcome [3] 340101 0
Interviews to determine the usability and acceptability of exciteBCI : Physiotherapists
Timepoint [3] 340101 0
Study part one: For the usability trial Interview will take place immediately after the participant has interacted with the exciteBCI and the usability tasks have been completed.
Secondary outcome [4] 340102 0
Interviews to determine the usability and acceptability of exciteBCI : People with stroke.
Timepoint [4] 340102 0
Study part one: For the usability trial Interview will take place immediately after the participant has interacted with the exciteBCI and the usability tasks have been completed.
Study part two: Immediately after the 3 week intervention is completed.
Secondary outcome [5] 340194 0
Strength Measurement: Changes in maximum voluntary contraction of the knee extensors using a force gage
Timepoint [5] 340194 0
Pre intervention and 3 days post completion of the 3-week intervention
Secondary outcome [6] 340195 0
Strength Measurement: Changes in maximum voluntary contraction of the hip flexors using a force gage
Timepoint [6] 340195 0
Pre intervention and 3 days post completion of the 3-week intervention
Secondary outcome [7] 340196 0
Safety
Timepoint [7] 340196 0
Safety monitored by recording any medical/physical changes at the beginning of each session, and any changes during the session. Unrelated events such as illness will be recorded and may result in a session being missed. Possible related events include superficial skin irritation related to electrode placement, or a headache due to wearing the EEG headset. Both of which are considered low risk. Any adverse events requiring the participant to seek medical attention from a health professional will be recorded on an adverse events form.

Eligibility
Key inclusion criteria
Stroke participants who meet the following inclusion criteria will be considered:
• Aged 18 years or more
• Stroke with hemiparesis affecting their ability to move their ankle
Physiotherapist participants in the usability trial (part 1) will be included if:
• They have 5 years’ experience in neurological rehabilitation
• Are able to attend a data collection session at AUT University
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Stroke Participants will be excluded if they:
• are unable to engage in the testing due to significant cognitive, perceptual or communication deficits
• have had a cerebellar stroke
• have another medical condition that may impact the testing or results

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
Part one of study (precedes intervention): Participants are asked to attend one 90 minute session to explore the usability and acceptability of exciteBCI. Potential users of the exciteBCI will be asked to perform a number of tasks using the exciteBCI whilst engaging in a ‘think-aloud’ process. This involves verbalising their thinking, observations and opinions whilst interacting with the exciteBCI. During the session observational and video recordings are made. The participants also take part in a short semi structured interview after the usability trial. The researcher will ask questions regarding the tasks, design features, pros and cons, and suggested improvements.
Phase
Not Applicable
Type of endpoint/s
Safety/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. Data form each of the quantitative measures for the two participants with stroke that participate in the 3-week intervention will be analysed using descriptive statistics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/11/2017
Actual
Date of last participant enrolment
Anticipated
31/01/2018
Actual
Date of last data collection
Anticipated
28/02/2018
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 9311 0
New Zealand
State/province [1] 9311 0
Auckland

Funding & Sponsors
Funding source category [1] 297832 0
University
Name [1] 297832 0
Auckland University of technology
Country [1] 297832 0
New Zealand
Funding source category [2] 297834 0
Commercial sector/Industry
Name [2] 297834 0
MedTech CoRE
Country [2] 297834 0
New Zealand
Funding source category [3] 297835 0
Commercial sector/Industry
Name [3] 297835 0
Callaghan Innovation C-Prize
Country [3] 297835 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Health and Rehabilitation Research Institute, Faculty of Health and Environmental Science, AUT University,
Private Bag 92006,
Auckland 1142.
Country
New Zealand
Secondary sponsor category [1] 296876 0
None
Name [1] 296876 0
None
Address [1] 296876 0
None
Country [1] 296876 0
Other collaborator category [1] 279786 0
Commercial sector/Industry
Name [1] 279786 0
Exsurgo Rehab Limited
Address [1] 279786 0
11J Piermark Drive
Albany
Auckland
0623
Country [1] 279786 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298881 0
Health and Disability Ethics Committees
Ethics committee address [1] 298881 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 298881 0
New Zealand
Date submitted for ethics approval [1] 298881 0
24/08/2017
Approval date [1] 298881 0
24/10/2017
Ethics approval number [1] 298881 0
17/NTA/177

Summary
Brief summary
The aim of this research is to investigate the usability and acceptability of exciteBCI a wearable rehabilitation device that is in a development and refinement phase, which aims to improve walking ability in people with stroke. The intervention has been tested previously and shown to be safe and effective when delivered using laboratory based equipment. We are making a smaller, lighter, portable version of the laboratory device, which can be used in clinical settings. We want to observe people with stroke and therapists while they use the device, and then interview them to find out what they think about the exciteBCI and how it could be made better. We will use these findings to modify the device to improve its usability and acceptability to clinicians and people with stroke. Following the incorporation of usability feedback, two stroke participants will take part in a 3 week physiotherapy intervention in which standard physiotherapy exercises will be supplemented with the exciteBCI.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78542 0
Prof Denise Taylor
Address 78542 0
Health and Rehabilitation Research Institute, Faculty of Health and Environmental Science, AUT University,
Private Bag 92006,
Auckland 1142.
Country 78542 0
New Zealand
Phone 78542 0
+64 9 921 9680
Fax 78542 0
Email 78542 0
[email protected]
Contact person for public queries
Name 78543 0
Miss Gemma Alder
Address 78543 0
Health and Rehabilitation Research Institute, Faculty of Health and Environmental Science, AUT University,
Private Bag 92006,
Auckland 1142.
Country 78543 0
New Zealand
Phone 78543 0
+64 9 921 9999 ext 7815
Fax 78543 0
Email 78543 0
[email protected]
Contact person for scientific queries
Name 78544 0
Miss Gemma Alder
Address 78544 0
Health and Rehabilitation Research Institute, Faculty of Health and Environmental Science, AUT University,
Private Bag 92006,
Auckland 1142.
Country 78544 0
New Zealand
Phone 78544 0
+64 9 921 9999 ext 7815
Fax 78544 0
Email 78544 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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