Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001147370
Ethics application status
Approved
Date submitted
27/07/2017
Date registered
7/08/2017
Date last updated
24/09/2021
Date data sharing statement initially provided
20/08/2019
Date results provided
24/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Australian Constraint Therapy Implementation study of the ARM: Use of a multimodal implementation package to change clinician behaviour and increase the delivery of constraint induced movement therapy (CIMT) programs to stroke survivors and people with traumatic brain injury.
Scientific title
Implementation of a sustainable publicly funded constraint induced movement therapy (CIMT) program to improve upper limb outcomes across multiple neurorehabilitation teams in South Western Sydney Local Health District (SWSLHD).
Secondary ID [1] 292548 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ACTIveARM (Australian Constraint Therapy Implementation study of the ARM)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 304202 0
traumatic brain injury 304203 0
Condition category
Condition code
Physical Medicine / Rehabilitation 303540 303540 0 0
Occupational therapy
Physical Medicine / Rehabilitation 303541 303541 0 0
Physiotherapy
Neurological 303550 303550 0 0
Other neurological disorders
Stroke 303551 303551 0 0
Haemorrhagic
Stroke 303552 303552 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed research will use a before and after study design. Mixed methods will be used to evaluate the impact of a CIMT implementation package on changes to clinician/team behaviour and practice in rehabilitation services at 5 sites across SWSLHD.

Data collection methods: Baseline data of CIMT delivery will be gathered via file audit at three baseline file audit time points. A barrier analysis will be conducted at baseline prior to delivery of the CIMT Implementation package and mid project to investigate CIMT knowledge, attitudes and organisational challenges using in-depth staff interviews. Team outcomes at all sites will be measured at baseline, and at 3-month intervals following delivery of a CIMT implementation package by an assessor up to 18 months post intervention using a file audit and feedback cycle.
An additional file audit time point (T7, n=20 files per team) will be conducted 24 months post-intervention, between January and March 2019, to evaluate sustainability of CIMT delivery. For people with stroke and brain injury participating in CIMT programs at the sites, upper limb outcomes will be measured at baseline, at the completion of CIMT intervention (i.e. 2 weeks) and 4 weeks post program intervention in line with routine delivery of a CIMT program.

Following collection of baseline data, therapy teams will receive a CIMT Implementation package. The package will include a) identification of local CIMT champions, b) 2 day training workshop to increase skills and knowledge, c) a community of practice via telephone d) onsite support during CIMT program implementation e) file audit feedback cycles at baseline and every 3 months post delivery of the implementation package up to 15 months post intervention. Below is a detailed outline of each component of the implementation package:

a) identification of local CIMT champions: Each team will nominate at least two local champions (one from physiotherapy and one from occupational therapy) with an interest in CIMT to act as the primary point of contact for the research team. The local champions will be responsible for driving CIMT implementation in their workplace and for participating in the Community of Practice.

b) 2 day training workshop: At a 2-day workshop, evidence for CIMT will be presented, as well as details of how previous teams have implemented CIMT into practice, with the support of AI McCluskey. At least two therapists per team will attend the workshop as designated CIMT champions. The workshop will address known local barriers identified during focus group interviews as well as previously identified barriers (Fleet et al., 2014) such as skills and knowledge. Volunteer stroke survivors and people with brain injury will be invited to participate to enable therapists to a) administer the Motor Activity Log (Uswatte et al., 2006) b) conduct timed trials and intensive practice c) deliver feedback on performance and record exercise repetitions in a simulated workshop environment. Training materials to be developed include written, video and photo resources, and reminder posters. The 2 day workshop will be held on two separate occasions (both run in March 2017) to maximise opportunities for therapist attendance whilst minimising disruption to clinical service delivery.

c) Onsite support: Teams will be provided with drop in onsite visits during each CIMT program to provide feedback on fidelity of CIMT delivery and assist with problem solving.

d) Telephone mentoring through a Community of Practice (CoP): CIMT champions from each team will participate in a monthly community of practice meeting via telephone, designed to provide support to staff setting up CIMT programs. The community of practice will be moderated by the Project Coordinator and include clinicians with previous experience implementing CIMT at pilot sites with AI McCluskey (McCluskey et al., 2015). Additional phone support will be provided between meetings.

e) Feedback about practice, recruitment to CIMT and patient outcomes via file audit feedback cycles: Feedback will be provided to each team at 3 month intervals about their practice, and patient outcomes following a CIMT program. These data will be collected via file audit (n=20 files per team per audit), and include the number of eligible participants offered and provided CIMT, the number of participants completing a two week CIMT program, the number of repetitions completed per day /week during CIMT.

CIMT Program delivery; People with either stroke or traumatic brain injury referred to these teams will be identified by their treating physiotherapist or occupational therapist on the team as eligible for CIMT. Participants who participate in a CIMT program as a part of their usual care will then be recruited by their treating therapist to:
a) Share their upper limb data and records of their practice (including video and photographs of assessment and practice; practice recording sheets and attendance logs) when completing a CIMT program;
b) Participate in an interview with a member of the research team following their CIMT program about their experiences of the program.

CIMT programs will be delivered via a range of models, dependent on the needs and resources of the team providing the program. This may be as either an individual or group based model of delivery. CIMT programs are generally delivered in a 2 to 3 week model with intervention varying from 3 to 5 days per week. Both occupational therapists and physiotherapists can be involved in the delivery of CIMT programs and may do so with the support of therapy assistants and/or therapy students. Programs may be delivered in a range of settings including inpatient hospital environments, outpatient therapy, community settings or the person's home.
Core components of a CIMT program include:
1. Intensive graded practice using the affected upper limb for 3-4 hours daily over 2 weeks, with 1:1 therapist coaching. This intensive graded practice combines both:
a) Functional task practice using the affected arm (e.g. activities such as preparing a sandwich, opening and closing drawers and dressing) and
b) Shaping tasks- activities targetting specific motor impairments usually completed in a series of 10 discrete timed trials of approximately 1 minute each. Examples of timed trial activities include flipping dominoes, reaching and grasping a cup and placing it on a target and attaching clothes pegs to a target. Shaping activities are made progressively more challenging over the course of the CIMT program with improvements in the person's upper limb function.
2. Constraint of the non-affected upper limb using a mitt for up to 90% of waking hours to encourage use of the affected hand in daily activities.
3. A home transfer package to promote carry over and sustained behaviour change. Components of the transfer package include daily completion of the Motor Activity Log, a home assignment of practice, a behavioural contract signed at the commencement of the CIMT program and a home diary (Kwakkel, Veerbeek, van Wegen, & Wolf, 2015).



People with either stroke or traumatic brain injury referred to these teams will be identified by a physiotherapist or occupational therapist on the team as eligible for CIMT. If they agree to participate in a 2 week CIMT program, organised and supervised by the local therapist (i.e. part of their usual care), these patients will be invited to participate in this research project. Inclusion criteria for participants to be identified as eligible for CIMT and this research project include: over 18 years old; sustained either a stroke or traumatic brain injury that resulted in mild to moderate upper limb dysfunction and reduced functional use of their upper limb; medically stable and able to participate in an intensive rehabilitation program (4 hours per day, 5 days per week for 2 weeks) as confirmed by a medical practitioner; able to read and understand spoken English to a level where they can comprehend the participant information sheet, complete the consent form and carry out self report outcome measures (including the Motor Activity Log (MAL)) with or without an interpreter or next of kin; residing at home, in supported accommodation, in a hostel or nursing home. Participants must meet upper limb criteria as outlined by Wolf et al. (2006) and Taub et al (1998). Higher functioning participants must demonstrate at least 20° of wrist extension and at least 10° of active extension of each metacarpophalangeal and interphalangeal joint of all fingers of the affected upper limb. Lower functioning participants must have at least 10° of active wrist extension, at least 10° of thumb abduction/extension, and at least 10° of extension in at least 2 additional fingers. These movements must be repeated 3 times in 1 minute.
Intervention code [1] 298744 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302909 0
The proportion of eligible people with stroke and traumatic brain injury who are offered CIMT as a component of their rehabilitation program.
Timepoint [1] 302909 0
Collected via file audit at baseline and three monthly intervals post delivery of CIMT implementation package (intervention) up to 18 months post intervention. An additional follow up audit timepoint will also be completed at 24 months to evaluate the sustainability of practice change once the implementation package has been withdrawn for 6 months.
Secondary outcome [1] 337416 0
9 hole Peg test (Lin, Chuang, Wu, Hsieh, & Chang, 2010)
Timepoint [1] 337416 0
Baseline
Post CIMT program
4 weeks follow up post CIMT program
Secondary outcome [2] 337429 0
Action Research Arm Test (Platz et al., 2005)
Timepoint [2] 337429 0
Baseline
Post CIMT program
4 week follow up post CIMT program
Secondary outcome [3] 337430 0
Motor Activity Log (Uswatte, Taub, Morris, Light, & Thompson, 2006)
Timepoint [3] 337430 0
Baseline
Post CIMT program
4 week follow up post CIMT program
Secondary outcome [4] 337431 0
Canadian Occupational Performance Measure (Cup, Scholte op Reimer, Thijssen, & van Kuyk-Minis, 2003).
Timepoint [4] 337431 0
Baseline
Post CIMT program
4 week follow up post CIMT program
Secondary outcome [5] 337432 0
RE-AIM framework
Timepoint [5] 337432 0
Pre implementation package
15 months post delivery of CIMT implementation package

Eligibility
Key inclusion criteria
Therapy teams: Therapy teams must employ at least one occupational therapist and one physiotherapist
Therapy team must receive referrals for at least 10 people with stroke or traumatic brain injury per year;
A minimum of two therapists per team and their therapy discipline manager will be involved.

CIMT participants: People with either stroke or traumatic brain injury referred to these teams will be identified by a physiotherapist or occupational therapist on the team as eligible for CIMT. If they agree to participate in a 2 week CIMT program, organised and supervised by the local therapist (i.e. part of their usual care), these patients will be invited to participate in this research project. Inclusion criteria for participants to be identified as eligible for CIMT and this research project include: over 18 years old; sustained either a stroke or traumatic brain injury that resulted in mild to moderate upper limb dysfunction and reduced functional use of their upper limb; medically stable and able to participate in an intensive rehabilitation program (4 hours per day, 5 days per week for 2 weeks) as confirmed by a medical practitioner; able to read and understand spoken English to a level where they can comprehend the participant information sheet, complete the consent form and carry out self report outcome measures (including the Motor Activity Log (MAL)) with or without an interpreter or next of kin; residing at home, in supported accommodation,
in a hostel or nursing home. Participants must meet upper limb criteria as outlined by Wolf et al. and Taub et al. Higher functioning participants must demonstrate at least 20° of wrist extension and at least 10° of active extension of each metacarpophalangeal and interphalangeal joint of all fingers of the affected upper limb. Lower functioning participants must have at least 10° of active wrist extension, at least 10° of thumb abduction/extension and at least 10° of extension in at least 2 additional fingers. These movements must be repeated 3 times in 1 minute.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Therapy teams employing only occupational therapy or physiotherapy, not both disciplines
Therapy team that receive less than at 10 referrals for people with stroke or traumatic brain injury per year;
Therapy teams containing only a single therapist

CIMT Participants: Participants will be excluded if they do not have: adequate communication and cognitive skills to consent and/or complete self rating scales; medical clearance; or if they do not live in the catchment area of the teams involved.
Participants with upper limb comorbidities (e.g. extreme pain and/or unstable lymphoedema) will also be excluded, as will those with a previous neurological event (such as previous stroke); or a Montreal Cognitive Assessment score of less than 18 (Nasreddine, 2016; Nasreddine et al., 2005) .
If an adverse event were to occur during the course of this study, the intervention would be ceased and the appropriate treatment sought. All adverse events will be reported.

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)
Allocation is not concealed
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
Efficacy
Statistical methods / analysis
Team and patient participant outcomes will be analysed and compared between baseline and follow-up time periods using descriptive statistics including proportions, means/standard deviations, or median/interquartile range. Differences in categorical data/dichotomous measures including proportions will be analysed using McNemar’s test. Differences in continuous outcomes will be analysed using either paired t-tests (pre-post) and 95% confidence intervals, or Friedman’s test (using multiple time points).

Qualitative data from interviews will be tape recorded, transcribed and coded into categories using the 14 conceptual domains of the TDF, described by Cane and colleagues, and used as the guiding theory (Cane et al., 2012). Statements will be categorised into domains that best reflect the content topic.

Recordings of the interviews will be transcribed verbatim by the interviewer after each interview with each team or participant. NVivo software will be used to assist with data management and analysis. Copies of the transcribed interviews will be provided to participants for review if requested, to check the accuracy of the transcript as one form of member checking (Bryman, 2004).Tables will be generated to summarise team experiences of barriers and enablers to CIMT implementation. A number of strategies will be used to enhance the rigour of the analysis. Triangulation of investigators will be used for the checking of codes to ensure consistency of coding and categorisation (Krefting, 1991). Peer examination will be used to ensure the trustworthiness of the data collection and analysis (Krefting, 1991).

Power/sample size calculation: Pilot data from AI McCluskey et al (2015) (McCluskey et al., 2015) indicate that about 30% of stroke survivors attending outpatient rehabilitation are typically eligible for CIMT and about half (15%) agree to participate in the intensive CIMT intervention for 4 hours per day for 2 weeks. In the pilot study, no file audits were completed to confirm this assumption. The proposed study will record the number/proportion of eligible patients who are a) offered CIMT b) provided with a CIMT program and c) complete 80% or more of a 2 week CIMT program. We estimate that currently no participants with stroke and traumatic brain injury are being offered or provided CIMT in any form across the 9 teams. We anticipate that a 10% change may occur through involvement in the study, but if 50% of eligible patient participants are offered CIMT, after implementation training, that change will be considered clinically important. The proposed study will enable a sample size and power calculation for a future randomised controlled trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/12/2016
Date of last participant enrolment
Anticipated
30/09/2019
Actual
1/10/2019
Date of last data collection
Anticipated
30/09/2019
Actual
1/10/2019
Sample size
Target
125
Accrual to date
Final
145
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8652 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 8653 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [3] 8654 0
Camden Hospital - Camden
Recruitment hospital [4] 8655 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [5] 8656 0
Braeside Hospital - Prairiewood
Recruitment postcode(s) [1] 16760 0
2170 - Liverpool
Recruitment postcode(s) [2] 16761 0
2200 - Bankstown
Recruitment postcode(s) [3] 16762 0
2570 - Camden
Recruitment postcode(s) [4] 16763 0
2560 - Campbelltown
Recruitment postcode(s) [5] 16764 0
2176 - Prairiewood

Funding & Sponsors
Funding source category [1] 297120 0
Government body
Name [1] 297120 0
NSW Ministry of Health Translational Research Grant Scheme
Country [1] 297120 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
Locked bag 7279
Liverpool BC
NSW 1871
Country
Australia
Secondary sponsor category [1] 296134 0
University
Name [1] 296134 0
The University of Sydney
Address [1] 296134 0
Faculty of Health Sciences
75 East Street
Lidcombe
NSW 2141
Country [1] 296134 0
Australia
Secondary sponsor category [2] 296135 0
Other
Name [2] 296135 0
The Ingham Institute for Applied Medical Research
Address [2] 296135 0
1 Campbell St, Liverpool
Locked bag 7279
Liverpool BC NSW 1871
Country [2] 296135 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298298 0
South Western Sydney Local Health District Research and Ethics Committee
Ethics committee address [1] 298298 0
Ethics committee country [1] 298298 0
Australia
Date submitted for ethics approval [1] 298298 0
25/07/2016
Approval date [1] 298298 0
16/11/2016
Ethics approval number [1] 298298 0
HREC/16/LPOOL/419

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

Contacts
Principal investigator
Name 76630 0
Ms Lauren Christie
Address 76630 0
St Vincent's Health Network, Sydney
Nursing Research Institute
Level 5 deLacy building
St Vincent's Public Hospital
390 Victoria St
Darlinghurst
NSW 2010
Country 76630 0
Australia
Phone 76630 0
+61 2 83824023
Fax 76630 0
+61287385497
Email 76630 0
[email protected]
Contact person for public queries
Name 76631 0
Lauren Christie
Address 76631 0
St Vincent's Health Network, Sydney
Nursing Research Institute
Level 5 deLacy building
St Vincent's Public Hospital
390 Victoria St
Darlinghurst
NSW 2010
Country 76631 0
Australia
Phone 76631 0
+61 2 83824023
Fax 76631 0
+61287385497
Email 76631 0
[email protected]
Contact person for scientific queries
Name 76632 0
Lauren Christie
Address 76632 0
St Vincent's Health Network, Sydney
Nursing Research Institute
Level 5 deLacy building
St Vincent's Public Hospital
390 Victoria St
Darlinghurst
NSW 2010
Country 76632 0
Australia
Phone 76632 0
+61 2 83824023
Fax 76632 0
+61287385497
Email 76632 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
Ethics documents indicated that only de-identified information would be used in any publications or presentations related to the trial


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.