Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001631392
Ethics application status
Approved
Date submitted
15/11/2017
Date registered
15/12/2017
Date last updated
8/11/2021
Date data sharing statement initially provided
2/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving arm function after stroke using task specific training
Scientific title
Improving arm function after stroke using task specific training
Secondary ID [1] 293372 0
NHMRC APP1129008
Universal Trial Number (UTN)
Trial acronym
Task-AT Home
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 305496 0
Condition category
Condition code
Stroke 304747 304747 0 0
Ischaemic
Stroke 304748 304748 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Task-specific intervention:

The intervention will be guided by a detailed protocol. The intervention will occur in the participant's home. In brief, the intervention therapist analyses the whole of the task which is to be trained, e.g. reach-to-grasp, to identify movement parts to be prioritised for training and individual movement performance targets to be reached. This will be necessarily different for each participant, The person's visual attention is directed to regulatory cues in the environment, which is organised to be functionally relevant, individualised and varied, by providing meaningful everyday objects of different sizes, weight and shape, in different positions. The therapist’s role is like a sports coach. He/she uses knowledge of critical biomechanical characteristics of the task to give instructions (by demonstration or verbally) which are concrete and task oriented. Repetitive practice and motor learning principles are used to empower the participant to practice on their own.

Training will be delivered according to an exercise manual containing 144 exercises words and photographs including variations of the exercises to allow for different levels of difficulty and complexity. Participants receive 14 x 1 hour visits from a therapist over the 6 weeks (3 visits week 1-3, 2 visits week 4-5, 1 visit week 6). This will replace any usual care training for the upper limb. The intensity of practice within each 1-hour session will be dependent on individual participant’s capabilities, but high numbers of repetitions will be encouraged, with the aim of delivering between 100 and 300 repetitions within each 1-hour session. Beyond the target of 100-300 reps, participants will do as many as they can accomplish in 1 hour, within limits of fatigue.

Task-specific training will be delivered by therapists appointed from the study budget. There will be a minimum of 4 therapists delivering treatment in each arm of the trial.

Self practice: Participants will be asked to perform in addition 1 hour/day of self-practice. Compliance is encouraged by joint goal-setting, providing a booklet about recovery from stroke emphasising potential for ‘rewiring’ the brain through practice (Smith, Forster et al. 2008), and using digital counters to record . The role of the carer will be to encourage the participant to practice and assist with equipment to enable practice and with recording practice.
Intervention code [1] 299629 0
Rehabilitation
Comparator / control treatment
Control intervention:

The control group for this trial will receive ‘usual care’. usual care will be provided according to the usual provision in the Local health District(s), by the usual staff (not staff employed on the trial). In usual care the frequency and content of physiotherapy is variable according to the individual’s pathway and the range of community services available but on the whole it is not intense. Community rehabilitation services may be delivered via early supported discharge, day hospital, community-based rehabilitation provided in the home or outpatient rehabilitation (http://strokefoundation.com.au/site/media/NSF_Audit-Report_2012_web2.pdf 2012). Participants typically receive two physiotherapist visits per week in early weeks after discharge from hospital with ~ 30 minutes of the visit focused on the arm. There may be supplementary visits from a support worker. usual care variously consists of facilitation of muscle activity, strengthening exercises, soft tissue and joint mobilisation, positioning, training of sensation, and education. Participants allocated to the current practice group will be provided with a booklet about recovery after stroke, with information about details of the frequency of assessment visits rather than about task-specific training.
Control group
Active

Outcomes
Primary outcome [1] 303968 0
Action Research Arm Test
Timepoint [1] 303968 0
immediately after the 6 weeks of intervention (primary time point)
at 6 months after intervention commencement
Secondary outcome [1] 340553 0
Motor Activity Log
Timepoint [1] 340553 0
immediately after the 6 weeks of intervention
at 6 months after intervention commencement
Secondary outcome [2] 340554 0
EQ5D
Timepoint [2] 340554 0
immediately after the 6 weeks of intervention
at 6 months after intervention commencement
Secondary outcome [3] 340555 0
Wolf Motor Function test
Timepoint [3] 340555 0
immediately after the 6 weeks of intervention and at 6 months after intervention
Secondary outcome [4] 340556 0
Fugl-Meyer Assessment - upper limb
Timepoint [4] 340556 0
immediately after the 6 weeks of intervention
at 6 months after intervention commencement
Secondary outcome [5] 340557 0
Caregiver Strain Index
Timepoint [5] 340557 0
immediately after the 6 weeks of intervention
at 6 months after intervention commencement
Secondary outcome [6] 340558 0
Modified Rankin Scale
Timepoint [6] 340558 0
immediately after the 6 weeks of intervention
at 6 months after intervention commencement
Secondary outcome [7] 340559 0
Kinematic measures (sub-study, 30 participants each group):
Composite secondary outcome: movement duration, peak hand velocity (PV), time of PV, peak hand deceleration (PD), time of PD, peak grasp aperture (GA), time of GA. Intra limb coordination will also be assessed by principal component analysis.
A Qualisys motion capture system will be used to collect data using a previously defined experimental paradigm (vanVliet and Sheridan 2007). In brief, participants perform 20 RtG movements to grasp, lift and replace a jar placed 90% arm’s length in front of them. Data will be filtered using a dual pass Butterworth filter with a 8-Hz cut-off, then kinematic variables will be extracted via custom Matlab programmes
Timepoint [7] 340559 0
immediately after the 6 weeks of intervention
at 6 months after intervention commencement

Eligibility
Key inclusion criteria
1. Diagnosis of primary or recurrent stroke , including stroke caused by focal cerebral infarction (ischemic stroke), intracerebral haemorrhage, subarachnoid haemorrhage and cerebral venous thrombosis (Sacco, Kasner et al. 2013)
2. Participant discharged home (i.e. permanent address, may include care home/sheltered accommodation)
3. Participant at approximately 3 months post stroke (between 2.5 and 3.5 months post stroke)
4. Has remaining upper limb movement deficit defined as being unable to pick up a 6mm ball bearing from the table top, between index finger and thumb, and place it on a shelf 37 cm above table (item from Action Research Arm Test)
5. Informed written consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Upper limb movement deficits attributable to non-stroke pathology
2. Unable to lift hand off lap when asked to place hand behind head
3. Severe fixed contractures of elbow or wrist (i.e. grade 4 on the modified Ashworth scale)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by internet-based service
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation sequence in a 1:1 ratio. Randomisation will be stratified by baseline severity of upper limb impairment (as defined below) using randomised blocks. Baseline severity will be categorized using scores on the ARAT (subgroups defined by Morris et al (Morris, Wijck et al. 2008) (Group 1: score 0-3; Group 2 score 4-28; Group 3 score 29-57)).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Proposed sample size = 300 participants

We aim to detect a minimal clinically important difference of 5 points on the ARAT, which derives from van der Lee (Vanderlee, Beckerman et al. 2001), who reported a difference of 5.7 for a mildly impaired population. The clinically important mean change for the ARAT for different severity groups are not yet published. We have adjusted to 5 to reflect the inclusion of moderate to severe impairment in our expected population, (feasibility study population included 37% participants with severe (ARAT 0-3) impairment). Based on observed values from our feasibility study, i.e. a pooled standard deviation on the ARAT of 18 and a correlation between baseline and follow-up of 0.72, 300 participants (150 per group) will provide the study with 80% power to detect the 5 point change on the ARAT at the 5% significance level (two-tailed test), allowing for a 20% loss to follow-up. Using similar assumptions, the study would have 80% power to detect differences between groups of 0.3SDs on the WMFI, MAL, SIS and the caregiver Strain Index. For kinematic measures, 30 per group will give 80% power to detect a difference of 0.74 SDs between groups. For peak velocity (SD = 80mm/s) this means 80% power to detect a difference between groups of 64mm/s.

Intention-to-treat (ITT) and per protocol (PP) analyses will be conducted. The ITT population will include all subjects who are randomised whereas the PP population will include those subjects who received 90% allocated treatment. The primary outcome measure (ARAT at the end of treatment (7 weeks)) will be analysed using analysis of covariance fitted within a Generalised Linear Mixed Model (GLMM) framework to adjust for the repeated measurements on individuals nested within therapists.. The outcome in the model will be the individuals ARAT at the end of treatment (7 weeks) ; the main predictors of interest in the model will be time (7 weeks/6 months), group (current practice/intervention) and the interaction of time by group. The model will also include the covariates of baseline ARAT score and site. Secondary outcome measures of MAL, WMFT, Kinematics, EQ5D, CSI, and MRS will be analysed using the same approach as used to test the primary outcome, with appropriate distributional families depending on the type of outcome.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2018
Actual
12/12/2018
Date of last participant enrolment
Anticipated
28/02/2022
Actual
Date of last data collection
Anticipated
28/08/2022
Actual
Sample size
Target
300
Accrual to date
31
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 15364 0
Hunter Medical Research Institute - New Lambton Heights
Recruitment hospital [2] 15365 0
The Maitland Hospital - Maitland
Recruitment hospital [3] 15366 0
Cessnock District Hospital - Cessnock
Recruitment hospital [4] 15367 0
Kurri Kurri District Hospital - Kurri Kurri
Recruitment hospital [5] 21047 0
Woy Woy Public Hospital - Woy Woy
Recruitment hospital [6] 21048 0
Gosford Hospital - Gosford
Recruitment hospital [7] 21049 0
Wyong Public Hospital - Hamlyn Terrace
Recruitment hospital [8] 21050 0
Long Jetty Health Care Facility - Killarney Vale
Recruitment hospital [9] 21051 0
Mt Wilga Private Hospital - Hornsby
Recruitment hospital [10] 21052 0
Berkeley Vale Private Hospital - Berkeley Vale
Recruitment hospital [11] 21053 0
Manning Rural Referral Hospital (Taree) - Taree
Recruitment postcode(s) [1] 28681 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 28682 0
2320 - Maitland
Recruitment postcode(s) [3] 28683 0
2325 - Cessnock
Recruitment postcode(s) [4] 28684 0
2327 - Kurri Kurri
Recruitment postcode(s) [5] 35889 0
2256 - Woy Woy
Recruitment postcode(s) [6] 35890 0
2250 - Gosford
Recruitment postcode(s) [7] 35891 0
2259 - Hamlyn Terrace
Recruitment postcode(s) [8] 35892 0
2261 - Killarney Vale
Recruitment postcode(s) [9] 35893 0
2077 - Hornsby
Recruitment postcode(s) [10] 35894 0
2430 - Taree

Funding & Sponsors
Funding source category [1] 297995 0
Government body
Name [1] 297995 0
National Health and Medical Research Council
Country [1] 297995 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan
NSW 2308
Country
Australia
Secondary sponsor category [1] 297061 0
None
Name [1] 297061 0
Address [1] 297061 0
Country [1] 297061 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299034 0
Hunter New England Health Research Ethics Committee
Ethics committee address [1] 299034 0
Hunter New England Local Health District, Locked Bag 1, New Lambton NSW 2305,
Ethics committee country [1] 299034 0
Australia
Date submitted for ethics approval [1] 299034 0
15/12/2017
Approval date [1] 299034 0
30/08/2018
Ethics approval number [1] 299034 0

Summary
Brief summary
For the 15 million new people each year globally suffering stroke, 85% have difficulty moving their arm and hand, and 60% still have non-functional arms 6 months after stroke. Evidence for more effective treatments is needed. This project is a multicentre randomised controlled study, with 300 participants, to test the hypothesis that task-specific training is more effective in improving upper limb function compared to usual care. Participants will be recruited from the community, at 3 months after stroke. They will receive 6 weeks treatment, at home, of either task-specific training or usual care. Task-specific training will be delivered according to a detailed exercise manual. Participants receive 14 x 1 hour visits from a therapist and will perform in addition 1 hour/day of self-practice. The primary outcome measure is the Action Research Arm Test performed immediately after the 6 weeks of treatment, and repeated at 6 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79062 0
Prof Paulette van Vliet
Address 79062 0
School of Humanities and Social Sciences, University of Newcastle, University Road, Callaghan, NSW, 2308
Country 79062 0
Australia
Phone 79062 0
+61 2 49217340
Fax 79062 0
Email 79062 0
[email protected]
Contact person for public queries
Name 79063 0
Dr Meredith Tavener
Address 79063 0
School of Humanities and Social Sciences, University of Newcastle, University Road, Callaghan, NSW, 2308
Country 79063 0
Australia
Phone 79063 0
+61 2 49215223
Fax 79063 0
Email 79063 0
[email protected]
Contact person for scientific queries
Name 79064 0
Prof Paulette van Vliet
Address 79064 0
School of Humanities and Social Sciences, University of Newcastle, University Road, Callaghan, NSW, 2308
Country 79064 0
Australia
Phone 79064 0
+61 2 49217340
Fax 79064 0
Email 79064 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study results for the group will be available, but not individual participants


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
EmbaseTask-specific training versus usual care to improve upper limb function after stroke: the "Task-AT Home" randomised controlled trial protocol.2023https://dx.doi.org/10.3389/fneur.2023.1140017
N.B. These documents automatically identified may not have been verified by the study sponsor.