Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001014448
Ethics application status
Approved
Date submitted
27/07/2016
Date registered
2/08/2016
Date last updated
7/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Tangible interaction with everyday objects for home­based upper­ limb stroke rehabilitation
Scientific title
Tangible interaction with everyday objects for home­based upper­ limb stroke rehabilitation
Secondary ID [1] 289771 0
Nil known
Universal Trial Number (UTN)
U1111-1176-3519
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
upper limb stroke rehabilitation 299647 0
Condition category
Condition code
Stroke 299597 299597 0 0
Haemorrhagic
Stroke 299598 299598 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this research is to enable chronic stroke patients (6+ months) who have experienced a mild to moderate stroke to conduct self­directed physical rehabilitation outside the clinical environment.

Participants will be interviewed (approx 30 minutes) about their health status, what kind of everyday activities are important to them and what kind of objects they engage with on a regular basis.

They will further be provided with a cultural probes kit that they can use for up to two weeks to document activities of daily living that they enjoy taking part in. A cultural probes kit contains a camera and some written instruction on what to photograph. It offers the opportunity to collect data that has a documentary and life­realistic character.

In order to determine what kinds of objects stroke survivors use in activities of daily living the method of design ethnography in the form of observations will be used as a third element (one session for approx 3 hours). Observations offer the possibility to gain a deeper understanding of what kind of objects are used by the stroke patients in activities of daily living.

Based on the collected information interactive design prototypes are designed that stroke survivors can use in a self-directed way. The participants are asked to give feedback on design prototypes that are based on the constraint­ induced therapy approach and test them to secure usability and efficiency of the devices (approx 30 minutes).

The participant information sheet is structured in a way that participants can choose to take part in all the steps or just single ones e.g. the initial interview.

The interviews, observation sessions and feedback sessions are run by the primary investigator Mailin Lemke. The primary investigator is an industrial designer with a background in interaction and industrial design and has observed physiotherapist and occupational therapist stroke rehabilitation sessions to understand the processes. Mailin Lemke attended a specific training focusing on constraint-induced therapy (21.02.2016, Auckland provided by Phillip Fay) and how it is applied to gain an understanding of the intervention.

Based on those themes just one interactive design prototype will be designed and tested by the participants. Common patterns and themes will be identified through interviews, observations and the use of cultural probes.

The interviews are estimated to be completed 2 months after recruitment. The use of the cultural probes will take place immediately after each of interviews. The observations will take place 2-3 months after the interviews. The final usability evaluation will take place after the design prototypes are developed. The final evaluation is scheduled to take place 6 months after the interviews

The design prototypes will be designed by the primary investigator Mailin Lemke. The usability evaluation carried out by the participants will assess if the physical design prototype is usable by the participants.
Mailin Lemke has experience in interaction and industrial design.

An interactive design prototype is a physical object in which different sensors are embedded to deliver components of constraint-induced movement therapy. The object has the size of a household item e.g. a toaster or radio or some other domestic object can be easily carried around. The sensors recognise if the participant uses the affected UE (i.e. the stroke-affected arm) during their interaction with and use of the object. In situations where the participant does not use the affected arm or hand, different forms of motivation are applied to encourage the use of the affected UE. One form of possible motivation might be augmented feedback the playing a voice recording to remind and encourage the user to use the affected UE.
Intervention code [1] 295425 0
Rehabilitation
Comparator / control treatment
The study is based on interviews, the use of cultural probes and observations of ADLs that stroke survivor like to participate in. A further element is the usability testing of interactive design prototypes. Those prototypes are just used under supervision and do not aim to prove the efficiency of the design prototypes but rather to get feedback by users to increase the usability. Therefore there is no control treatment involved in this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299068 0
Usability evaluation of interactive design prototypes that aim to incorporate the constraint induced movement therapy in the interaction
Usability will be assessed via semi structured interviews.
Timepoint [1] 299068 0
One year post commencement
Secondary outcome [1] 326057 0
Determination of activities of daily living that stroke survivors (6 months +) like to engage in.
The activities are determined through the initial interview, the use of cultural probes and observation.
Timepoint [1] 326057 0
5 months post commencement
Secondary outcome [2] 326102 0
Determination of objects that play an important role in activities of daily living that stroke survivors (6 months +) like to engage in.
The activities are determined through the initial interview, the use of cultural probes and observation.
Timepoint [2] 326102 0
5 months post commencement

Eligibility
Key inclusion criteria
The inclusion criteria for this study are:
the experience of a stroke at least 6 months prior to the interview
living at home, an active wrist and finger
the ability to walk independently
an age of 40-75 years
and good general health

Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are
signs of severely impaired verbal communication
inability to give consent
severe neurocognitive deficits
excessive pain in any joint of the paretic arm
terminal illness
or life-threatening comorbidities

Study design
Purpose of the study
Educational / counselling / training
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
Statistical methods / analysis
Participant numbers
Qualitative analysis and usability research requires smaller numbers of participants, typically between 6 to 10, compared to quantitative research, where 30 to 40 participants are required. As a result, this study will require around 8 participants.

Thematic analysis will be used for the data analysis of the different methods used in this study,

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2017
Actual
Date of last participant enrolment
Anticipated
31/01/2018
Actual
Date of last data collection
Anticipated
28/02/2018
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 8052 0
New Zealand
State/province [1] 8052 0

Funding & Sponsors
Funding source category [1] 294153 0
University
Name [1] 294153 0
Research Trust of Victoria University of Wellington, NZ
Country [1] 294153 0
New Zealand
Primary sponsor type
University
Name
Prof Simon Fraser
Address
School of Design
Victoria University of Wellington
Room 235A
139 Vivian Street
Te Aro Campus
Wellington
New Zealand
6021
Country
New Zealand
Secondary sponsor category [1] 292984 0
None
Name [1] 292984 0
Address [1] 292984 0
Country [1] 292984 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295562 0
Health and Disability Ethics Committees
Ethics committee address [1] 295562 0
Ethics committee country [1] 295562 0
New Zealand
Date submitted for ethics approval [1] 295562 0
10/03/2016
Approval date [1] 295562 0
02/06/2016
Ethics approval number [1] 295562 0
16/CEN/37

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 975 975 0 0
/AnzctrAttachments/371177-HDEC_research_protocol.pdf
Attachments [2] 976 976 0 0
/AnzctrAttachments/371177-HDEC Letter 16CEN37_Approved FULL Application.pdf

Contacts
Principal investigator
Name 67766 0
Miss Mailin Lemke
Address 67766 0
School of Design
Victoria University of Wellington
139 Vivian Street
Te Aro Campus
Wellington 6011
Country 67766 0
New Zealand
Phone 67766 0
+64 (0)226470388
Fax 67766 0
Email 67766 0
[email protected]
Contact person for public queries
Name 67767 0
Mailin Lemke
Address 67767 0
School of Design
Victoria University of Wellington
139 Vivian Street
Te Aro Campus
Wellington 6011
Country 67767 0
New Zealand
Phone 67767 0
+64 (0)226470388
Fax 67767 0
Email 67767 0
[email protected]
Contact person for scientific queries
Name 67768 0
Brian Robinson
Address 67768 0
Graduate School of Nursing, Midwifery and Health
Victoria University of Wellington
P O Box 7625
Newtown
Wellington 6242
Country 67768 0
New Zealand
Phone 67768 0
+64 (0)4 463 6155
Fax 67768 0
Email 67768 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes January 2019 DOI: 10.1080/09638288.2018.1543460

Documents added automatically
No additional documents have been identified.