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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.

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).

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001147370
Acronym
ACTIveARM (Australian Constraint Therapy Implementation study of the ARM)
Enrollment
145
Registered
2017-08-07
Start date
2016-12-01
Completion date
2019-10-01
Last updated
2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Rationale: Constraint Induced Movement Therapy (CIMT) is an effective intervention for upper limb recovery following stroke and traumatic brain injury (TBI) that produces significant improvements in upper limb function compared to usual therapy, after only 2 weeks (Stevenson, Thalman, Christie, & Poluha, 2012). Despite the robust body of evidence for CIMT, there is a knowledge translation gap between research and use in clinical practice (Fleet et al., 2014; Viana & Teasell, 2012). Lack of therapist knowledge of the CIMT protocol has been identified as one key barrier (Fleet et al., 2014) – one that is amenable to change with training. Aim: To establish if a 2-week publicly funded CIMT program can be translated into practice and sustained over 2 years across multiple health services in SWSLHD. Design: 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 in SWSLHD. Sample: The sample will include occupational therapists and physiotherapists at 5 sites across SWSLHD and their patient participants in CIMT programs (n=100). Data collection methods: Baseline data of CIMT delivery will be gathered via file audit. A barrier analysis will be conducted at baseline prior to delivery of the CIMT Implementation package and post 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 15 months post intervention. 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 6 weeks later. Intervention: 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. Outcome measures: Primary outcome: The proportion of eligible people with stroke and traumatic brain injury who are offered CIMT as a component of their rehabilitation program. Secondary outcome: CIMT participant outcomes will be obtained at baseline, 2 weeks and 6 weeks following CIMT intervention including: a) Action Research Arm Test b) Motor Activity Log c) 9 hole Peg test d) Canadian Occupational Performance Measure The RE-AIM framework will also be used to evaluate program transferability. Discussion: Occupational therapists, physiotherapists, allied health assistants and managers within NSW Health will overcome an evidence-practice gap through routine delivery of a recommended, highly effective intervention.

Interventions

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 projec

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.

Sponsors

South Western Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 18, 2026