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.

Not Applicable

Completed

• Conditions: stroke; traumatic brain injury; Physical Medicine / Rehabilitation - Occupational therapy; Physical Medicine / Rehabilitation - Physiotherapy; Neurological - Other neurological disorders; Stroke - Haemorrhagic; Stroke - Ischaemic

• Registration Number: ACTRN12617001147370
• Lead Sponsor: South Western Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-07
• Study Completion: 2019-10-01
• Last Update Posted: 4 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 145

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of eligible people with stroke and traumatic brain injury who are offered CIMT as a component of their rehabilitation program.[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 Measures

Name	Time	Method
9 hole Peg test (Lin, Chuang, Wu, Hsieh, & Chang, 2010) [Baseline<br>Post CIMT program<br>4 weeks follow up post CIMT program];Action Research Arm Test (Platz et al., 2005) [Baseline<br>Post CIMT program<br>4 week follow up post CIMT program];Motor Activity Log (Uswatte, Taub, Morris, Light, & Thompson, 2006)[Baseline<br>Post CIMT program<br>4 week follow up post CIMT program];Canadian Occupational Performance Measure (Cup, Scholte op Reimer, Thijssen, & van Kuyk-Minis, 2003).[Baseline<br>Post CIMT program<br>4 week follow up post CIMT program];RE-AIM framework[Pre implementation package <br>15 months post delivery of CIMT implementation package]