Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000447459
Ethics application status
Approved
Date submitted
7/03/2016
Date registered
6/04/2016
Date last updated
3/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Training therapists to coach individuals with a neurological condition to use the SMART Arm.
Scientific title
Design and evaluation of an advanced SMART Arm train-the-trainer course, for Occupational Therapists, Physiotherapists and Rehab Assistants, focused on coaching individuals with a neurological condition to use the SMART Arm to drive their own recovery.
Secondary ID [1] 288705 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 297928 0
Neurological conditions 297929 0
Condition category
Condition code
Stroke 298092 298092 0 0
Ischaemic
Stroke 298093 298093 0 0
Haemorrhagic
Neurological 298094 298094 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention to be developed and evaluated is is a SMART Arm train-the-trainer course, for Occupational Therapists, Physiotherapists and Rehab Assistants. The SMART Arm is a device designed for individuals with upper limb paresis as a result of stroke or other neurological conditions to enable them to undertake task-oriented practice and to achieve the intensity of practice required to promote recovery

The train-the-trainer course will be focused on teaching clinicians how to coach individuals with a neurological condition to use the SMART Arm independently in order to drive their own recovery in the long term. In small groups (~4-8) the clinician will learn to coach the individual with a neurological condition to set-up, practice and progress optimally, either independently, or with only a significant other to help them. The ultimate goal of SMART Arm training is for stroke survivors to practice without a clinician present.

The steps towards developing the train-the-trainer course are as follows:
1. Determine requirements for a SMART Arm train-the trainer course
2. Develop a SMART Arm train-the trainer course and corresponding Capabilities Assessment Tool
3. Pilot the SMART Arm train-the trainer course with clinicians who use the SMART Arm at CRnQ
4. Evaluate the SMART Arm train-the trainer course and make recommendations for refinement.

Phase 1:
Participating clinicians will attend train-the-trainer courses, practice coaching with individuals with a neurological condition and provide feedback on their coaching skills and capabilities.
Participating individuals with a neurological condition will act as models during the training courses, will undertake SMART Arm training to allow clinicians to practice coaching and will provide feedback on clinicians coaching capabilities through a survey questionnaire, focus group and individual interviews and through completion of the capabilities assessment tool.

On commencement of the trial, all participating clinicians at the trial site (Community Rehab nQ) will have completed one standard 90 minute group coaching session with an accompanying manual, on operation of the device and delivery of basic coaching for the stroke survivor. The session will be conducted by Ruth Barker who is the Lead Inventor or the SMART Arm and a Master trainer. The standard group coaching session will consist of 30 minutes introduction to the device, a 30 minutes demonstration with a stroke survivor; and a 30 minutes Q & A session. From that point onwards, participating clinicians will coach individuals with a neurological condition to undertake SMART Arm training. As per standard practice, the clinician will determine the number of sessions and the specific SMART Arm training elements (e.g. set-up, load, elevation, hand position and involvement) in order to match each individuals' goals and upper limb deficits. At the end of their rehabilitation program, each individual with a neurological condition will provide feedback on clinician's skills in coaching by completing a survey questionnaire and if they wish, attending a focus group or individual interview with the researcher, This feedback will be coupled with the best available evidence to guide development of a 'Train-the-trainer' course and corresponding capability assessment tool.

Phase II:
Participating clinicians will attend the newly developed train-the-trainer course and complete the capability assessment tool at three time-points (Post training, 3 months and 6 months).
Participating individuals with a neurological condition will once again, act as models during the train-the- trainer courses, allow clinicians to practice coaching by participating in SMART Arm training and provide feedback on clinicians coaching capabilities through completion of the capabilities assessment tool.

The train-the-trainer course will be conducted in a small group format (~4-8 clinicians) by Ruth Barker. It is anticipated to run for a full day (or two half days) and to consist of the following:
i) Operation of the SMART Arm device
ii) SMART Arm training incorporating and progressing all essential training elements to drive upper limb recovery for a person with a neurological condition
iii) Coaching individuals with a neurological condition to undertake and progress SMART Arm training so that they can drive their own recovery
iv) Training new /rotating clinicians in i), ii), and iii).

A register of attendance at all training sessions will be completed.
Intervention code [1] 294131 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297608 0
Strengths and weaknesses of current SMART Arm coaching will be assessed concurrently. This outcome will be assessed via a survey questionnaire designed specifically for this study.
All participating individuals will complete the survey questionnaire. A selection of participating individuals with a neurological condition and a selection of clinicians will be invited to participate in individual or focus group interviews to verify and explain the survey findings.
Timepoint [1] 297608 0
3 months after commencement of the trial
Secondary outcome [1] 321576 0
Therapists capability to coach individuals with a neurological condition to use the SMART Arm. This will be assessed using a capability assessment tool designed specifically for this study by participating individuals with a neurological condition and via self-report by participating clinicians.
Timepoint [1] 321576 0
6 months after commencement of the trial.

Eligibility
Key inclusion criteria
1) Individuals with a neurological condition
Inclusion: Individuals with a neurological condition aged over 15 years whose arm function has been reduced as a result of the neurological condition, and that receive a service from Community Rehab nQ during the study period.

2) Occupational therapists, physiotherapists and rehabilitation assistants working at CRnQ who have participated in basic SMART Arm training as a minimum.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals with a neurological condition who are unable to 'actively participate' in SMART Arm training. For example people with cognitive-linguistic impairments that limit their ability to understand and follow instructions sufficiently to enable participation.

Occupational Therapists, Physiotherapists and Rehab Assistants who have not received the basic SMART Arm training will be excluded from the study.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis
A sequential mixed methods design will be utilised with a sample of 40 individuals with a neurological condition and 10 clinicians working at CRnQ. The sample size was determined by calculating the number of potential participants with a neurological condition who will attend Community Rehab nQ over the trial period and the number of potential participants working as a Physiotherapist, Occupational Therapist or Rehab Assistant over the trial period.


Phase I will involve development and administration of a quantitative and qualitative survey questionnaire to determine requirements for SMART Arm Advanced Training. Quantitative survey data will be collated and analysed descriptively. Qualitative data from focus group interviews will be analysed descriptively. Information gained will be used to inform selection of content and mode of instruction used in the Train-the-Trainer Course and corresponding Capability Assessment Tool.

Phase II will involve development and piloting of the SMART Arm Advanced Train-the Trainer Course materials and corresponding Capability Assessment Tool and will be based on Phase I outcomes. Quantitative data arising from the Capability Assessment Tool will be collated and analysed descriptively. Qualitative data from focus group interviews will be analysed descriptively. Information gained will be used to refine the Train-the-Trainer Course and Capabilities Assessment Tool.


Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
26/04/2016
Actual
Date of last participant enrolment
Anticipated
19/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 293065 0
University
Name [1] 293065 0
James Cook University
Country [1] 293065 0
Australia
Funding source category [2] 293066 0
Other
Name [2] 293066 0
Northern Australia Primary Health Ltd
Country [2] 293066 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
Cairns Campus
14-88 McGregor Rd
Smithfield Queensland 4878
Country
Australia
Secondary sponsor category [1] 291846 0
Other
Name [1] 291846 0
Northern Australia Primary Health Ltd
Address [1] 291846 0
16 Ryan St
Belgian Gardens
Townsville Queensland 4810
Country [1] 291846 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294574 0
James Cook University
Ethics committee address [1] 294574 0
Ethics committee country [1] 294574 0
Australia
Date submitted for ethics approval [1] 294574 0
14/10/2015
Approval date [1] 294574 0
17/02/2016
Ethics approval number [1] 294574 0
C19

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 798 798 0 0
/AnzctrAttachments/370287-Protocol Version 1 Dated 15 September 2015.pdf

Contacts
Principal investigator
Name 64206 0
A/Prof Ruth Barker
Address 64206 0
College of Healthcare Sciences
Division of Tropical Heath and Medicine
James Cook University
Cairns Campus
14-88 McGregor Rd
Smithfield Queensland 4878
Country 64206 0
Australia
Phone 64206 0
+61 7 42321614
Fax 64206 0
+61 7 42321216
Email 64206 0
[email protected]
Contact person for public queries
Name 64207 0
Robin Warren
Address 64207 0
Community Rehab nQ
Northern Australia Primary Health Ltd
16 Ryan St
Belgian Gardens
Townsville Queensland 4810
Country 64207 0
Australia
Phone 64207 0
+61 7 4228700
Fax 64207 0
+61 7 4228799
Email 64207 0
[email protected]
Contact person for scientific queries
Name 64208 0
Ruth Barker
Address 64208 0
College of Healthcare Sciences
Division of Tropical Heath and Medicine
James Cook University
Cairns Campus
14-88 McGregor Rd
Smithfield Queensland 4878
Country 64208 0
Australia
Phone 64208 0
+61 7 42321614
Fax 64208 0
+61 7 42321216
Email 64208 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.