Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000933550
Ethics application status
Approved
Date submitted
29/05/2015
Date registered
7/09/2015
Date last updated
23/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Changing practice in the assessment and treatment of somatosensory loss in stroke survivors: An Implementation study
Scientific title
Does evidence-based implementation of SENSe therapy result in improved upper limb somatosensory function in stroke survivors compared to those who receive usual care when delivered by trained occupational therapists and physiotherapists in clinical practice settings?
Secondary ID [1] 285714 0
None
Universal Trial Number (UTN)
U1111-1164-4146
Trial acronym
SENSe Implement: Study of the Effectiveness of Neurorehabilitation on Sensation, An Implementation Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 293588 0
Condition category
Condition code
Stroke 293873 293873 0 0
Ischaemic
Stroke 293876 293876 0 0
Haemorrhagic

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

1. Clinicians (occupational therapists and physiotherapists)
2. Stroke survivors presenting with sensory loss

Participant Group 1 (Clinicians):

Theory-based implementation strategies (i.e, group educational workshops and interactive online resources) will be provided to occupational therapists and physiotherapists working with stroke survivors from participating health organisations.

Examples of theory-based implementation strategies to be used are:
1. Barrier identification and evaluation through implementation questionnaires
2. Group-based educational workshops providing training in evidence-based assessment and treatment methods for post-stroke somatosensory loss (the SENSe approach, Carey et al., 2011)
3. Establishment of site-specific champion-therapists through liaison between participating sites and the research team
4. Provision of written materials and online resources relevant to post-stroke sensory assessment and treatment.

Carey, L.M, Macdonell, R., & Matyas, T. A. (2011). SENSe: Study of the Effectiveness of Neurorehabilitation on Sensation A Randomized Controlled Trial. Neurorehabilitation and neural repair, 25(4), 304-313.

Theoretical approaches to guide implementation interventions will be based primarily on the Theoretical Domains Framework and the Behaviour Change Wheel (Cane et al., 2012; Michie et al., 2005; Michie, van Stralen & West, 2011).

Michie S, van Stralen MM, West R. The behaviour change wheel: A new method for characterising and designing behaviour change interventions. Implement Sci. 2011; 6(1): 42.

Michie, S., Johnston, M., Abraham, C., Lawton, R., Parker, D., & Walker, A. (2005). Making psychological theory useful for implementing evidence based practice: a consensus approach. Quality and safety in health care, 14(1), 26-33.

Cane, J., O’Connor, D., & Michie, S. (2012). Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Science, 7(1), 37.

Therapists will be up-skilled in assessment (training sessions of ~ 5 hours, over 3 sessions across 3 weeks ) and treatment (training sessions of ~8 hours, over 3 sessions across 3 weeks) approaches using interactive workshops facilitated by trained clinical researchers and involving multimedia resources.

Participant Group 2 (Stroke survivors):

Stroke survivors will be provided with SENSe therapy or usual care. SENSe is an upper limb therapy package for use with stroke survivors (Carey et al., 2011) comprising modules to train:

* Tactile discrimination
* Limb position sense
* Tactile object recognition
* Occupational performance in tasks selected as meaningful by the client

Carey, L.M, Macdonell, R., & Matyas, T. A. (2011). SENSe: Study of the Effectiveness of Neurorehabilitation on Sensation A Randomized Controlled Trial. Neurorehabilitation and neural repair, 25(4), 304-313.

Stroke survivors will receive 10 therapy sessions of 60 minute duration with sessions aimed at a rate of 3 per week, with variations depending on the nature of service delivery of participating sites. SENSe therapy sessions are one-on-one between therapist and patient.

Usual care, as comparison to SENSe therapy, will constitute the therapy currently being provided to treat stroke survivors with sensory loss and the frequency of sessions and timeframes for delivery will be dependent on usual practices of participating sites. Details of therapy provided as part of usual care will be monitored via a questionnaire and results will be interpreted with reference to ‘usual care’ as defined by a recent cross-sectional study of 172 therapists across Australia (Pumpa et al., 2015).

Pumpa, L., Cahill, L., & Carey, L.M. (2015). Somatosensory assessment and treatment after stroke: An evidence practice gap. Australian Occupational Therapy Journal. 62(2).

Phases of this study include:

Phase 1: Therapists implement evidence-based quantitative assessment of sensation using the SENSeAssess tool. Treatment approaches to address sensory loss remain unchanged (usual care).
Phase 1 will commence after 3 weeks of SENSe Assess training has been completed.

Phase 2: Therapists implement an evidence-based treatment approach (SENSe Therapy) with stroke clients.
Stroke survivors will receive 10 therapy sessions of 60 minute duration. SENSe therapy sessions are one-on-one between therapist and patient.

Phase 2 will commence after 3 weeks of SENSe therapy training has been completed.
Intervention code [1] 290669 0
Rehabilitation
Intervention code [2] 291950 0
Early detection / Screening
Intervention code [3] 291951 0
Treatment: Other
Comparator / control treatment
Usual Care. During Phase 1 of the study, occupational therapists and physiotherapists will provide usual care (in relation to sensory rehabilitation) to stroke survivors. Usual care is the therapy normally provided to stroke survivors and is likely to have natural variations depending on the local context. In the context of this study, usual care will be interpreted with reference to ‘usual care’ as reported in a cross-sectional study of current practices in somatosensory assessment and treatment (Pumpa, 2015). For example, the results of this Australian review of practice indicated therapists predominantly use compensatory strategies and sensory re-education in the treatment of stroke survivors with somatosensory loss.

Pumpa, L., Cahill, L., & Carey, L.M. (2015). Somatosensory assessment and treatment after stroke: An evidence practice gap. Australian Occupational Therapy Journal. 62(2).
Control group
Active

Outcomes
Primary outcome [1] 293661 0
Participate Group 1 (Clinicians):
Effective implementation will be evaluated via clinician questionnaires specifically designed for this study and focus groups. An audit of medical histories will also be used.
Timepoint [1] 293661 0
Participant Group 1 (Clinicians):
Questionnaires and focus groups will be conducted at baseline prior to phase one (usual care), following recruitment of half of the site-specific nominated sample (~6-8 month timeframe) and after the period of implementation of SENSe therapy (~6-8 month timeframe). Audit of histories will occur following phase 1 and phase 2.
Primary outcome [2] 295290 0
Participant Group 2 (Stroke Survivors): Improved upper limb somatosensory function in stroke survivors will be measured by the SENSeAssess© tool (Carey et al. 2013). SENSeAssess© is a composite measure of functional somatosensory discrimination capacity derived from standardised measures of texture discrimination, limb position sense and tactile object recognition. Tests contributing to the composite measure of sensation will address texture discrimination (Tactile Discrimination Test, Carey, Oke & Matyas, 1997), limb position sense (Wrist Position Sense Test, Carey, Oke & Matyas, 1996) and tactile object recognition (Functional Tactile Object Recognition Test, Carey et al., 2006). Each component measure has age-adjusted normative standards, high reliability (r = 0.85 to 0.92) and good discriminative test properties. Carey L, Mak Y, Tan A-M, Rickard, K and Matyas T. (2013) Development of a Somatosensory Screening Tool for use in Clinical Rehabilitation Settings with Stroke Survivors. Stroke Society of Australasia. Carey, L., Oke, L., & Matyas, T. (1997). Impaired touch discrimination after stroke: a quantitative test. Neurorehabilitation and Neural Repair, 11, 219-232. Carey, L., Oke, L., & Matyas, T. (1996) Impaired limb position sense after stroke: a quantitative test for clinical use. Archives of Physical Medicine Rehabilitation, 77, 1271-1278.
Timepoint [2] 295290 0
Participant Group 2 (Stroke survivors):
Quantitative sensory assessments will be conducted at baseline and after a period of usual-care control intervention (time period determined by participating therapist, typically across a 4-6 week interval) and at baseline and after SENSe therapy intervention (time period determined by participating therapist, typically across a 4-6 week interval).
Secondary outcome [1] 314871 0
Participant Group 2 (Stroke survivors):
The Hand Function Survey (HFS) (Blennerhassett, Avery & Carey, 2010)
The HFS is a questionnaire designed to measure self-reported ability to use the affected hand during 13 everyday tasks in people with stroke. The HFS has established psychometric properties and is practical for clinical use.

Blennerhassett, J., Avery, R., & Carey, L. (2010). The test-retest reliability and responsiveness to change for the Hand Function Survey during stroke rehabilitation. Australian Occupational Therapy Journal, 57(6), 431-438.
Timepoint [1] 314871 0
To be conducted at baseline and after a period of usual care control intervention (time period determined by therapist, typically across a 4-6 week interval) and at baseline and after SENSe therapy intervention (time period determined by participating therapist, typically across a 4-6 week interval).
Secondary outcome [2] 314872 0
Participant Group 2 (Stroke survivors):
The Jebsen Taylor Hand Function Test (JTHFT) (Jebsen et al., 1969)
The JTHFT has been widely used, has favorable psychometric properties and has the advantage of normative scores for age, gender and hand dominance. The two items of the JTHFT selected for this study involve a pinch grip action.

Jebsen, R., Taylor, N., Trieschmann, R., Trotter, M., & Howard, L. (1969). An objective and standardized test of hand function. Archives of Physical Medicine and Rehabilitation, 50, 311-319.
Timepoint [2] 314872 0
To be conducted at baseline and after a period of usual care control intervention (time period determined by therapist, typically across a 4-6 week interval) and at baseline and after SENSe therapy intervention (time period determined by participating therapist, typically across a 4-6 week interval).
Secondary outcome [3] 314873 0
Participant Group 2 (Stroke survivors):
The Canadian Occupational Performance Measure (Law et al., 1990) will be used to measure a stroke survivor’s individually identified problem areas in daily function relating to sensory impairments of the upper limb.

Law M, Baptiste S, McColl MA, Opzoomer A, Polatajko H & Pollock N.(1990). The Canadian Occupational Performance Measure: An outcome measure for occupational therapy. Canadian Journal of Occupational Therapy, 57(2), 82-87.
Timepoint [3] 314873 0
To be conducted at baseline and after SENSe therapy intervention (time period determined by participating therapist, typically across a 4-6 week interval) in phase 2 only (as it is linked with treatment planning and outcomes specifically for sensation).

Eligibility
Key inclusion criteria
Participant Group 1 (Clinicians):
i. Qualified in occupational therapy or physiotherapy
ii. Employed at a site involved in the study
iii. Provider of services to stroke patients

Participant Group 2 (Stroke survivors):
i. Stroke diagnosis
ii. Presenting with impaired touch sensation, limb position sense and/or tactile object recognition of the upper limb
iii. Medically stable
iv. Able to give informed consent
v. Able to follow 3-stage instructions and sustain attention for treatment
vi. Aged 18 years and above
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participant Group 1 (clinicians):
i. Not working with stroke patients
ii. Not working at a site involved in the study

Participant Group 2 (stroke survivors):
i. Not medically stable
ii. Evidence of unilateral spatial neglect
iii. Prior history of other central nervous system dysfunction (excluding stroke)
iv. Peripheral neuropathy of the upper limb
v. Not able to comprehend simple instructions or sustain attention for treatment
vi. Not able to give informed consent

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)
Allocation is not concealed. Consecutive sampling will be used to recruit stroke clients.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
A within and between site before and after study with usual care and SENSe Intervention groups.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power calculation was used to determine the number of participants needed to achieve study objectives. Based on an effect size of d=0.79 from the randomised controlled trial of SENSe Therapy (Carey et al., 2011) and 80% power, taking into account the potential impact of variation in therapist experience and adaptation to local context, our sample size is based on 80% power for detecting an effect that is 0.6 of the SENSe d, i.e. n=140.

Methods of data analysis:

Participant Group 1 (Clinicians):
Quantitative information from clinician questionnaires and qualitative components of focus group discussion will be collected. Descriptive statistics and thematic analysis will be used to interpret results.

Participant Group 2 (Stroke Survivors):
Planned comparisons of pre-post intervention data will contrast:

i) the reduction in standardised sensory deficit score during 'usual care' and SENSe rehabilitation phases (the group effect of SENSe intervention across sites and patients).

ii) reduction in standardised sensory deficit score during 'usual' compared to SENSe intervention at each site, taking into account possible clinic effect.

Comparison will occur statistically through a two factor ANOVA with centre (health organization sites) and Intervention (usual care, SENSe therapy) being the two factors.

Confidence intervals will be determined for the mean differences between the intervention and 'usual care' groups to estimate typical effect magnitudes.

An independent statistician will perform a blinded analysis of pre- and post- test data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/12/2014
Actual
8/12/2014
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
50
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 3824 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 3825 0
Royal Talbot Rehabilitation Centre - Kew
Recruitment hospital [3] 3826 0
Epworth Rehabilitation Camberwell - Camberwell
Recruitment hospital [4] 3827 0
Epworth Rehabilitation Brighton - Brighton
Recruitment hospital [5] 3828 0
Epworth Richmond - Richmond
Recruitment hospital [6] 3829 0
Barwon Health - McKellar Centre campus - North Geelong
Recruitment hospital [7] 3830 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [8] 7320 0
St John of God Nepean Rehabilitation Hospital - Frankston
Recruitment hospital [9] 7321 0
Ryde Hospital - Eastwood
Recruitment hospital [10] 7322 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [11] 7323 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 9715 0
3084 - Heidelberg
Recruitment postcode(s) [2] 9716 0
3101 - Kew
Recruitment postcode(s) [3] 9717 0
3124 - Camberwell
Recruitment postcode(s) [4] 9718 0
3186 - Brighton
Recruitment postcode(s) [5] 9719 0
3121 - Richmond
Recruitment postcode(s) [6] 9720 0
3215 - Geelong North
Recruitment postcode(s) [7] 9721 0
3550 - Bendigo
Recruitment postcode(s) [8] 15095 0
3199 - Frankston
Recruitment postcode(s) [9] 15096 0
2122 - Eastwood
Recruitment postcode(s) [10] 15097 0
3065 - Fitzroy
Recruitment postcode(s) [11] 15098 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 291332 0
University
Name [1] 291332 0
La Trobe University
Building Health Communities Grant
Country [1] 291332 0
Australia
Funding source category [2] 291333 0
University
Name [2] 291333 0
La Trobe University
PhD Scholarships
Country [2] 291333 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Plenty Road & Kingsbury Drive
Bundoora
Victoria
3086
Country
Australia
Secondary sponsor category [1] 290013 0
Other
Name [1] 290013 0
Florey Institute of Neuroscience and Mental Health
Address [1] 290013 0
Melbourne Brain Centre
Austin Campus
245 Burgundy Street
Heidelberg
Victoria
3084
Country [1] 290013 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292895 0
Austin Human Research Ethics Committee
Ethics committee address [1] 292895 0
Ethics committee country [1] 292895 0
Australia
Date submitted for ethics approval [1] 292895 0
Approval date [1] 292895 0
11/06/2013
Ethics approval number [1] 292895 0
H2013/04956
Ethics committee name [2] 292896 0
Epworth Human Research Ethics Committee
Ethics committee address [2] 292896 0
Ethics committee country [2] 292896 0
Australia
Date submitted for ethics approval [2] 292896 0
Approval date [2] 292896 0
27/08/2014
Ethics approval number [2] 292896 0
646-14
Ethics committee name [3] 292897 0
La Trobe University Human Ethics Committee
Ethics committee address [3] 292897 0
Ethics committee country [3] 292897 0
Australia
Date submitted for ethics approval [3] 292897 0
Approval date [3] 292897 0
11/11/2014
Ethics approval number [3] 292897 0
FHEC14/243
Ethics committee name [4] 296679 0
St John of God Healthcare
Ethics committee address [4] 296679 0
Ethics committee country [4] 296679 0
Australia
Date submitted for ethics approval [4] 296679 0
28/08/2015
Approval date [4] 296679 0
09/09/2015
Ethics approval number [4] 296679 0
861
Ethics committee name [5] 296680 0
Northern Sydney Local Health District
Ethics committee address [5] 296680 0
Ethics committee country [5] 296680 0
Australia
Date submitted for ethics approval [5] 296680 0
16/10/2015
Approval date [5] 296680 0
12/04/2016
Ethics approval number [5] 296680 0
HREC/15/313

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

Contacts
Principal investigator
Name 52982 0
Prof Leeanne Carey
Address 52982 0
Head, Neurorehabilitation and Recovery, Stroke Division, The Florey Institute of Neuroscience and Mental Health, Melbourne Brain Centre - Austin Campus, 245 Burgundy Street, Heidelberg, Victoria, 3084.

and

Professor, Allied Health, College of Science, Health and Engineering, La Trobe University. La Trobe University, Bundoora, Victoria, 3083
Country 52982 0
Australia
Phone 52982 0
+61 3 9035 7088
Fax 52982 0
+61 3 9035 7303
Email 52982 0
[email protected]
Contact person for public queries
Name 52983 0
Leeanne Carey
Address 52983 0
Head, Neurorehabilitation and Recovery, Stroke Division, The Florey Institute of Neuroscience and Mental Health, Melbourne Brain Centre - Austin Campus, 245 Burgundy Street, Heidelberg, Victoria, 3084.

and

Professor, Allied Health, College of Science, Health and Engineering, La Trobe University. La Trobe University, Bundoora, Victoria, 3083
Country 52983 0
Australia
Phone 52983 0
+61 3 9035 7088
Fax 52983 0
+61 3 9035 7303
Email 52983 0
[email protected]
Contact person for scientific queries
Name 52984 0
Leeanne Carey
Address 52984 0
Head, Neurorehabilitation and Recovery, Stroke Division, The Florey Institute of Neuroscience and Mental Health, Melbourne Brain Centre - Austin Campus, 245 Burgundy Street, Heidelberg, Victoria, 3084.

and

Professor, Allied Health, College of Science, Health and Engineering, La Trobe University. La Trobe University, Bundoora, Victoria, 3083
Country 52984 0
Australia
Phone 52984 0
+61 3 9035 7088
Fax 52984 0
+61 3 9035 7303
Email 52984 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
SourceTitleYear of PublicationDOI
EmbaseChanging practice in the assessment and treatment of somatosensory loss in stroke survivors: protocol for a knowledge translation study.2018https://dx.doi.org/10.1186/s12913-018-2829-z
EmbaseFactors influencing allied health professionals' implementation of upper limb sensory rehabilitation for stroke survivors: A qualitative study to inform knowledge translation.2021https://dx.doi.org/10.1136/bmjopen-2020-042879
N.B. These documents automatically identified may not have been verified by the study sponsor.