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Trial registered on ANZCTR


Registration number
ACTRN12618001389291
Ethics application status
Approved
Date submitted
13/08/2018
Date registered
20/08/2018
Date last updated
10/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Network of sites and ‘up-skilled’ therapists to deliver best-practice stroke rehabilitation of the upper limb.
Scientific title
Network of sites and ‘up-skilled’ therapists to deliver best-practice stroke rehabilitation of the upper limb.
Secondary ID [1] 295704 0
None
Universal Trial Number (UTN)
Trial acronym
SENSe CONNECT
Linked study record
Study title: “Changing practice in the assessment and treatment of somatosensory loss in stroke survivors: An Implementation study”: Australian New Zealand Clinical Trials Registry ACTRN12615000933550. This study also involves upskilling of therapists to deliver an evidence-based intervention during stroke rehabilitation. The intervention is known as "SENSe Therapy". The linked study aims to embed SENSe Therapy into usual care. (The submitted study involves a different service model.)

Health condition
Health condition(s) or problem(s) studied:
Stroke 309091 0
Physical medicine / rehabilitation 309092 0
Somatosensory impairment 309094 0
Impaired functional use of the hand 309095 0
Condition category
Condition code
Stroke 307964 307964 0 0
Haemorrhagic
Stroke 307965 307965 0 0
Ischaemic
Physical Medicine / Rehabilitation 307966 307966 0 0
Occupational therapy
Physical Medicine / Rehabilitation 307967 307967 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two participant groups are provided with interventions:

1. People with stroke and somatosensory loss
2. Therapists (occupational therapists and physiotherapists)

Participant Group 1 (People with stroke) – will receive SENSe Therapy.

SENSe Therapy (as outlined in the Study of the Effectiveness of Neuro-rehabilitation on Sensation, by Carey et al., 2011), is a science and evidence based rehabilitation therapy to improve the sense of touch when touching objects and using the hand in everyday tasks. The intervention will be delivered face to face by Occupational Therapists and/or Physiotherapists within specialist therapy centres. The intervention involves sensory discrimination training of texture discrimination, sensing the position of the upper limb in space, recognising objects through the sense of touch and learning how to apply these skills in daily tasks identified by the person with stroke. The intervention will be tailored according to level of impairment and functional goals. The dose will be 10 one-hour sessions, over a period of 6 weeks. The frequency of sessions will be 1 to 2 times a week. Fidelity of the intervention will be assessed using checklists (with self-evaluation and evaluation via an independent blinded SENSe Trainer) and audit of treatment notes.

Carey, L.M., R. Macdonnell, and T. Matyas, SENSe: Study of the Effectiveness of Neurorehabilitation on Sensation. A randomized controlled trial. Neurorehabilitation and Neural Repair, 2011. 25: p. 304-313.

Participant Group 2 (Therapists) – will be involved in an implementation intervention to change behaviour.

Occupational therapists and physiotherapists will be involved in an implementation intervention and receive training to deliver SENSe Therapy. Therapists will be up-skilled in delivery of SENSe Therapy using interactive workshops facilitated by trained clinical researchers and involving multimedia resources. The workshops will involve 3 x 4 hours sessions, and be supported by independent learning modules (estimated to take 1 to 2 hours each). The participants who are therapists will also receive supervision and mentoring so they can deliver SENSe Therapy to people with stroke within specialist therapy centres. The knowledge and skill of therapists will be measured before, during and after delivery of SENSe Therapy and during the up-skilling process. Confidence and ability to deliver SENSe Therapy will be evaluated, and will include assessment of treatment fidelity. Treatment fidelity will include self-evaluation and assessment by blinded SENSe Therapy Trainers. This process will use criterion checklists to rate fidelity of the intervention observed via video recordings, and documented in the treatment notes.
Intervention code [1] 302024 0
Rehabilitation
Intervention code [2] 302025 0
Treatment: Other
Comparator / control treatment
No active control group
Participants with stroke will have a wait list control period of 6 weeks following consent to determine baseline status.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306948 0
Participants with Stroke: Somatosensory capacity as assessed by the Somatosensory Deficit Score (SSD), which is a composite measure of sensory function calibrated to normal age-matched performance in the upper limb (Carey et al 2011).


Carey, L.M., R. Macdonnell, and T. Matyas, SENSe: Study of the Effectiveness of Neurorehabilitation on Sensation. A randomized controlled trial. Neurorehabilitation and Neural Repair, 2011. 25: p. 304-313.
Timepoint [1] 306948 0
Timepoint: After 6 weeks of SENSe Therapy intervention.
Primary outcome [2] 306949 0
Primary outcome for Participants who are Therapists will be ability to deliver SENSe therapy with 80% fidelity measured by criterion based checklists and audits of treatment delivery.
Timepoint [2] 306949 0
Timepoint: Fidelity will be measured regularly across the upskilling process. The upskilling intervention provided to therapists refers to education and the delivery of SENSe therapy (with clinical mentoring) to 12 participants with stroke.
The primary outcome will be assessed after the therapist has completed their upskilling package, which will be after they have delivered SENSe Therapy to 12 participants with stroke. (Note, regular assessments of fidelity are needed for training purposes).
Secondary outcome [1] 350207 0
Secondary outcome 1. Participants with stroke.
Motor Activity Log
Uswatte, G., et al., The Motor Activity Log-28: Assessing daily use of the hemiparetic arm after stroke. Neurology, 2006. 67: p. 1189-1194.
Timepoint [1] 350207 0
Timepoint: After 6 weeks intervention and at follow up (12 weeks later)
Secondary outcome [2] 350208 0
Secondary outcome 2. Participants with stroke.
Canadian Occupational Performance Measure
Law, M., et al., Canadian Occupational Performance Measure. 4th ed ed. 2005, Ottawa: CAOT Publications ACE
Timepoint [2] 350208 0
Timepoint: Immediately after the 6 weeks intervention. The outcome will be repeated at follow up, which is 12 weeks after completing the intervention..
Secondary outcome [3] 350209 0
Secondary outcome 3. Participants with stroke.
Health-related Quality of Life; Assessment of Quality of Life.
Sturm, J., et al., Brief comprehensive quality of life assessment after stroke. The assessment of quality of life instrument in the North East Melbourne Incidence Study (NEMESIS). Stroke, 2002. 33: p. 2888-2894.
Timepoint [3] 350209 0
Timepoint: Immediately after the 6 weeks intervention. The outcome will be repeated at follow up, which is 12 weeks after completing the intervention..
Secondary outcome [4] 350210 0
Secondary outcome 4: Participants who are Therapists. Therapist knowledge, skill and confidence will be assessed using pre-post questionnaires. The questionnaire has been been designed specifically for this study (and the linked study, as mentioned in section 1.), and explores aspects of therapist confidence, skill, and knowledge.

Timepoint [4] 350210 0
Timeframe: Before upskilling, and after upskilling. Please note, the upskilling intervention provided to therapists refers to education and the delivery of SENSe therapy (with clinical mentoring) to 12 participants with stroke.
The secondary outcome will be measured immediately before, and immediately after the therapist has completed upskilling.
Secondary outcome [5] 350211 0
Secondary outcome 5: Economic costs and outcomes will be assessed in an economic simulation model developed for this project. This will incorporate program costs (eg to deliver the service and train staff), clinical outcomes, self-reported resource use and quality of life (Assessment of Quality of Life: AQoL-6D). One-way and probabilistic sensitivity analyses (Monte-Carlo simulated) will be undertaken to assess the robustness of results.


Timepoint [5] 350211 0
Timeframe: The financial costs of delivering the service will be collated across the upskilling process, and intervention phase.
Outcomes for participants with stroke (resource use and AQoL-6D) will be measured on 4 occasions: (6 weeks before intervention, immediately before intervention, after completing 6 weeks intervention, and 12 weeks after completing).
Economic simulation modelling will compare 2 phases: 1) in the 6 weeks period before participants with stroke receiving intervention, and 2) in the 12 weeks after they complete the intervention.

Eligibility
Key inclusion criteria
Key inclusion criteria are listed for the two groups of participants.

Participants with stroke.
* A clinical diagnosis of stroke: This can include infarct, haemorrhage, brainstem events, infarct following subarrachoid haemorrhage, and can include people with a second stroke. There will be no restriction on time since stroke.
* Impaired touch sensation, limb position sense, and/or tactile object recognition of the upper limb, identified clinically and by standardized tests.
*Medically stable
* Able to give informed consent (with the use of an interpreter if English language proficiency is not sufficient to communicate study information adequately).
* Comprehend simple instructions (follow 3 stage instructions and sustain attention for treatment)
* Willing to commit time to participate in the SENSe Therapy program
*Living in the community.

Participants who are Therapists:
* Occupational Therapist or Physiotherapist
* Registered to practice.
* Willing to participate in the training, undertake evaluation and actively participate in mentoring in order to develop competency to deliver SENSe Therapy.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For participants with stroke.
* Not medically stable
* Sensory impairment is not due to stroke (eg carpal tunnel syndrome)
* Severe unilateral spatial neglect
* Prior history of other central nervous system dysfunction with unstable or progressive prognosis.
* Severe peripheral neuropathy in the upper limb
* Severe to moderate cognitive impairment
* Not able to comprehend simple instructions or sustain attention needed to participate in treatment
* Not able to give informed consent
* Physical limitations that prevent participate in therapy tasks (e.g., contracture of the hand, or unhealed wounds.)
* Unable to participate in a clinical appointment lasting 30 minutes


There are no additional exclusion criteria for the participants who are therapists.

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The study is employing an implementation science approach to change therapist practice and implement evidence based practice.
A wait list control method will be used to evaluate outcomes for the participants with stroke. Assessors for health outcomes of participants with stroke will be blinded to study design and timing of intervention delivery.

Participants who are therapists and their assessors of behaviour change will not be blinded.

Data analysts will be blinded to study design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed to:
1) Examine if patient outcome has been improved after receiving SENSe therapy. Pre-post outcomes will be compared to determine the magnitude of therapeutic change. The magnitude of therapeutic change pre-post SENSe Therapy will be determined as an effect size and compared to the benchmark effect size obtained in the previous SENSe randomized control trial (comparable cohort). Significance will be considered using 95% confidence intervals. Clinically significant improvement in sensory function and performance in client-selected activities will be determined. Sustainability of the intervention effect will be evaluated at the 3-month follow up

2) Examine if therapists have been effectively upskilled to deliver SENSe therapy. Pre and post-tests, questionnaires of knowledge, confidence and ability to deliver SENSe Therapy will be examined. ‘Effective delivery’ will be defined as a score of 80% or higher on the treatment fidelity, as measured by criterion checklists.

3) Evaluate the effect of amount of therapist experience in the delivery of SENSe therapy (i.e. number of patients SENSe is delivered to) on patient outcome. The potential “experience effect” will be explored by modelling clinical outcomes during delivery of SENSe to 12 sequential participants with stroke for each of 16 therapists. The experience trajectories for each of the therapists will be determined by the effect size obtained for each client and the client’s position in the treatment series.

4) Economic costs associated with implementing the model of service delivery, and impact for consumers will be collected prospectively during the project. An economic simulation model will then be developed to estimate the cost per quality adjusted life year (QALY) gained from the SENSe therapy compared to baseline status.

Sample size estimations:
*Participants with stroke: This study is powered to detect small changes in arm sensory function following up-skilling of therapists based on our primary outcome (improvement in averaged Standardized Somatosensory Deficit, SSD). Assuming the variability in changes found in the SENSe RCT is replicated in the delivery of SENSe Therapy in the specialist therapy centres and 192 cases are observed, the 95% precision interval for mean improvement is expected to be ± 1.88 averaged SSD units. Thus our sample size of n=192 has a high degree of precision for estimating the effect size obtained within the SENSe Therapy Centre program.

* Participants who are therapists: A sample of 16 therapists has been chosen to deliver SENSe Therapy at the specialist therapy centres to maximise replication (required for upskilling in an implementation trial) and yet examine the effect of experience for the repeated delivery of SENSe Therapy.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/09/2018
Actual
Date of last participant enrolment
Anticipated
17/09/2021
Actual
Date of last data collection
Anticipated
17/12/2021
Actual
Sample size
Target
208
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 11554 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 11555 0
The Alfred - Prahran
Recruitment hospital [3] 11556 0
Hunter Medical Research Institute - New Lambton Heights
Recruitment hospital [4] 11682 0
UniSA Health and Medical Clinic (City West) - Adelaide
Recruitment postcode(s) [1] 23582 0
3084 - Heidelberg
Recruitment postcode(s) [2] 23583 0
3004 - Prahran
Recruitment postcode(s) [3] 23584 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 23728 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 300288 0
Government body
Name [1] 300288 0
National Health and Medical Research Council (NHMRC) partnership grant.
Country [1] 300288 0
Australia
Funding source category [2] 300290 0
Hospital
Name [2] 300290 0
Austin Health.
Country [2] 300290 0
Australia
Funding source category [3] 300291 0
Hospital
Name [3] 300291 0
Alfred Hospital
Country [3] 300291 0
Australia
Funding source category [4] 300293 0
Government body
Name [4] 300293 0
Hunter New England Health
Country [4] 300293 0
Australia
Funding source category [5] 300294 0
University
Name [5] 300294 0
UniSA Health
Country [5] 300294 0
Australia
Funding source category [6] 300295 0
Charities/Societies/Foundations
Name [6] 300295 0
National Stroke Foundation
Country [6] 300295 0
Australia
Primary sponsor type
Individual
Name
Professor Leeanne Carey
Address
Professor and Discipline Lead Occupational Therapy,
Department of Community and Clinical Allied Health,
School of Allied Health, College of Science Health and Engineering
La Trobe University, Bundoora, VIC, 3086.
Country
Australia
Secondary sponsor category [1] 299718 0
University
Name [1] 299718 0
La Trobe University
Address [1] 299718 0
Research Office
La Trobe University
Bundoora, Vic 3086
Country [1] 299718 0
Australia
Secondary sponsor category [2] 299840 0
University
Name [2] 299840 0
The Florey Institute of Neuroscience and Mental Health
Address [2] 299840 0
30 Royal Parade.
Parkville, 3052
Country [2] 299840 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301099 0
Austin Human Research Ethics Committee
Ethics committee address [1] 301099 0
Ethics committee country [1] 301099 0
Australia
Date submitted for ethics approval [1] 301099 0
11/07/2018
Approval date [1] 301099 0
21/08/2018
Ethics approval number [1] 301099 0
HREC/18/Austin/153

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85882 0
Prof Leeanne Carey
Address 85882 0
Professor and Discipline Lead Occupational Therapy,
Department of Community and Clinical Allied Health,
School of Allied Health, College of Science Health and Engineering
La Trobe University, Bundoora, VIC, 3086.

and
Head, Neurorehabilitation and Recovery, Stroke Division
The Florey Institute of Neuroscience and Mental Health
Melbourne Brain Centre - Austin Campus
245 Burgundy Street, Heidelberg Vic 3084
Country 85882 0
Australia
Phone 85882 0
+61 3 9479 5600
Fax 85882 0
+61 3 9497 5737
Email 85882 0
l.carey@latrobe.edu.au
Contact person for public queries
Name 85883 0
Leeanne Carey
Address 85883 0
Professor and Discipline Lead Occupational Therapy,
Department of Community and Clinical Allied Health,
School of Allied Health, College of Science Health and Engineering
La Trobe University, Bundoora, VIC, 3086.

and
Head, Neurorehabilitation and Recovery, Stroke Division
The Florey Institute of Neuroscience and Mental Health
Melbourne Brain Centre - Austin Campus
245 Burgundy Street, Heidelberg Vic 3084
Country 85883 0
Australia
Phone 85883 0
+61 3 9479 5600
Fax 85883 0
+61 3 9497 5737
Email 85883 0
l.carey@latrobe.edu.au
Contact person for scientific queries
Name 85884 0
Leeanne Carey
Address 85884 0
Professor and Discipline Lead Occupational Therapy,
Department of Community and Clinical Allied Health,
School of Allied Health, College of Science Health and Engineering
La Trobe University, Bundoora, VIC, 3086.

and
Head, Neurorehabilitation and Recovery, Stroke Division
The Florey Institute of Neuroscience and Mental Health
Melbourne Brain Centre - Austin Campus
245 Burgundy Street, Heidelberg Vic 3084
Country 85884 0
Australia
Phone 85884 0
+61 3 9479 5600
Fax 85884 0
+61 3 9497 5737
Email 85884 0
l.carey@latrobe.edu.au

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
SourceTitleYear of PublicationDOI
Dimensions AICharacterizing Touch Discrimination Impairment from Pooled Stroke Samples Using the Tactile Discrimination Test: Updated Criteria for Interpretation and Brief Test Version for Use in Clinical Practice Settings2023https://doi.org/10.3390/brainsci13040533
N.B. These documents automatically identified may not have been verified by the study sponsor.