Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000079943
Ethics application status
Approved
Date submitted
10/01/2020
Date registered
30/01/2020
Date last updated
17/10/2022
Date data sharing statement initially provided
30/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of a complex therapy within Rehabilitation in the Home for patients receiving upper limb therapy after stroke.
Scientific title
Modified constraint induced movement therapy after stroke: a process evaluation of implementation within an early-supported discharge rehabilitation service.
Secondary ID [1] 300223 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 315785 0
Stroke Rehabilitation 315787 0
Condition category
Condition code
Stroke 314072 314072 0 0
Haemorrhagic
Stroke 314073 314073 0 0
Ischaemic
Physical Medicine / Rehabilitation 314074 314074 0 0
Physiotherapy
Physical Medicine / Rehabilitation 314075 314075 0 0
Occupational therapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study seeks to evaluate the implementation of modified constraint-induced movement therapy (mCIMT) within RITH. Modified constraint-induced movement therapy is a rehabilitation therapy for upper limb impairment after stroke. Rehabilitation in the Home (RITH) has developed it's own program, fit for purpose within an early-supported discharge setting.

Patients will receive RITH and mCIMT regardless of whether they are involved in this study. The decision to receive mCIMT will be based on therapist and patient collaboration during goal setting and treatment planning. This study seeks to determine whether the RITH mCIMT implementation program has led to more eligible patients receiving mCIMT as part of their rehabilitation with RITH.

This program consists of the described components of constraint-induced movement therapy (CIMT):
- Transfer package which is a set of behavioural strategies to facilitate patient use of their stroke-affected arm outside of scheduled therapy time (Behavioural Contract, regular administration of the Motor Activity Log, training diary and home skills assignment).
- Intensive practice (shaping tasks and repetitive task practice)
- Constraint of the less-affected upper limb (such as a mitt, oven mitt, glove or sling)

Definitions:
Functional task practice- repetitive practice of tasks that are encountered on a day to day basis. These tasks are completed repetitively over a period of time (ie: 10min). Examples include using the more-affected arm to button shirts, using a spoon to feed self, drink from a cup, using a key to lock/unlock doors, and write with a pen.

Shaping- a series of graduated upper limb tasks which target particular movement deficits that the therapist feels has the greatest potential to improve and fit with patient preferences for exercise. Shaping looks to improve motor skills at an impairment level, whereas functional task practice looks to improve function at the activity/participation level. Shaping tasks are generally timed or measured, to provide immediate feedback on performance to the patient which can be motivating but also highlight deficiencies. An example of a shaping task is measuring how many playing cards a patient can turn over in a 30 second period. This task targets pincer/lateral prehension grip, wrist and finger movement, forearm supination and pronation and elbow extension. As a patient improves, their speed and quality of movement increases to allow for more cards to be flipped. Shaping tasks are identified from observation of functional task performance and determination of what movement deficits may be contributing to impaired performance. Shaping tasks can also include components of a full functional task (part-practice).

Adherence to program- mCIMT requires engagement and accountability from the patient. During the program, the patient (or carer if required) completes a training diary daily which documents the time spent wearing a constraint and a log of the functional task practice completed. This is reviewed on each RITH therapist visit (3 times per week) and the patient is questioned if there are deviations from the program agreed upon.

The Behavioural Contract and Motor Activity Log (MAL) are completed prior to commencing the program. The RITH program is 2 weeks in duration, with 3 therapist visits per week during this period.
Each RITH visit is 1 hour in duration and comprises completion of the MAL, provision and review of a training diary/home skills assignment, and completion of shaping tasks- generally 4-5 separate shaping tasks targeted at particular movement deficits.

Participants are expected to complete at least 2 hours of independent functional task practice daily during this period, and encouraged to wear a constraint on their less-affected upper limb for up to 6 hours a day. The amount of practice a participant performs each day is reviewed by the visiting therapist on each visit.

Carers are encouraged to support patients in completing this program.

Outcome measures are completed at the completion of the 2 week program.
Intervention code [1] 316496 0
Not applicable
Comparator / control treatment
No
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322465 0
Uptake of mCIMT
- Percentage of patients admitted to RITH eligible to receive mCIMT
- Proportion of eligible patients offered mCIMT
- Proportion of eligible patients received mCIMT
This is a composite outcome. This information will be obtained through audit of patient RITH notes (patient records) after their discharge from RITH.
Timepoint [1] 322465 0
6 month data collection period over 2 timepoints - Patients admitted to RITH between July 1st- December 31st 2021, and July 1st- December 31st 2022. Patient data will not be collected until after discharge from RITH,
Primary outcome [2] 322467 0
Patient and carer perceptions and experiences.
This is a composite outcome.

Patients eligible to receive mCIMT who did/did not receive mCIMT during their RITH admission will be invited to participate in a one-on-one semi-structured interview. This interview will be audio-recorded and transcribed verbatim. Thematic analysis will conducted by the research team.
Carers of patients who received mCIMT during their RITH admission will be invited to participate in a one-on-one semi-structured interveiw. This interview will be audio-recorded and transcribed verbatim. Thematic analysis will be conducted by the research team.

All interviews will be no longer than 60 minutes and conducted in a location of most convenience to the participant, most likely their home. Note: it is standard practice for RITH therapists to visit a patient in their home and safety screening occurs for all patients.
Timepoint [2] 322467 0
Feb 1st 2020- December 31st 2021
Primary outcome [3] 322690 0
RITH Physiotherapist, Occupational Therapist, Therapy Assistant and Manager perceptions and experiences.
This is a composite outcome.

RITH therapists, therapy assistants and managers will be invited to participate in focus groups using a semi-structured interview guide. Focus groups will contain between 4-8 staff members, will be audio-recorded and transcribed verbatim. Thematic analysis will be conducted by the research team.
Timepoint [3] 322690 0
Feb 1st 2020- December 31st 2021
Secondary outcome [1] 378625 0
Cost description
- Description of costs to RITH service in delivering mCIMT to patients
- Includes patient service utilisation (number of occasions of service)
- Discharging service (outpatient therapy, private therapy)
- Data collected with be combined with existing quality improvement data on developing the RITH mCIMT implementation package

Costs to the health service will be collated using hospital records to determine number of occasions of service. These data will only be collected for consenting participants. RITH is a Tier 2 Outpatient service as per Activity Based Funding, so each occasion of service provides a set cost depending on the clinic code.

Costs for developing the RITH mCIMT implementation package will be based on:
- Therapist time for attending to training sessions (maintained through training register) and combined with labour costs (known from Health Services Union Award)
- Time for RITH service to develop resources (time spent developing resources logged)
- Costs for venue hire at each training session (in-kind funding, however time and cost to external trainers will be used)
- Time spent for clinical support provided by expert peers to therapists (all support provided in terms of time, travel and vehicle costs have been logged).
Timepoint [1] 378625 0
6 months - Patients admitted to RITH between July 1st 2020- December 31st 2020. Patient data will not be collected until after discharge from RITH.

Eligibility
Key inclusion criteria
Quantitative
Admitted to RITH with diagnosis of stroke
Referred for physiotherapy and/or occupational therapy
Upper limb impairment as a result of stroke

Qualitative
Patient who was eligible to receive mCIMT within RITH or,
Carer of patient who received mCIMT, or
RITH physiotherapist, occupational therapist, therapy assistant, coordinator or manager
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Quantitative
- Cognitive or communication impairment limiting ability to provide informed consent using modified consent forms

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2020
Actual
1/07/2020
Date of last participant enrolment
Anticipated
21/10/2022
Actual
Date of last data collection
Anticipated
30/12/2022
Actual
Sample size
Target
550
Accrual to date
286
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 304654 0
Government body
Name [1] 304654 0
Rehabilitation in the Home- South Metropolitan Health Service, Western Australia Health
Country [1] 304654 0
Australia
Funding source category [2] 310097 0
Government body
Name [2] 310097 0
Department of Health- Western Australia
Country [2] 310097 0
Australia
Funding source category [3] 312459 0
Charities/Societies/Foundations
Name [3] 312459 0
Spinnaker Health Research Foundation
Country [3] 312459 0
Australia
Primary sponsor type
Individual
Name
Ashan Weerakkody
Address
Rehabilitation in the Home
L5, Fremantle Hospital
Alma St
Fremantle, WA 6160
Country
Australia
Secondary sponsor category [1] 304958 0
None
Name [1] 304958 0
Address [1] 304958 0
Country [1] 304958 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305074 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 305074 0
Ethics committee country [1] 305074 0
Australia
Date submitted for ethics approval [1] 305074 0
16/10/2019
Approval date [1] 305074 0
14/11/2019
Ethics approval number [1] 305074 0
RGS0000003058
Ethics committee name [2] 305075 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [2] 305075 0
Ethics committee country [2] 305075 0
Australia
Date submitted for ethics approval [2] 305075 0
10/12/2019
Approval date [2] 305075 0
23/12/2019
Ethics approval number [2] 305075 0
2019-00989-WEERAKKODY

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

Contacts
Principal investigator
Name 99178 0
Mr Ashan Weerakkody
Address 99178 0
Rehabilitation in the Home
L5, Fremantle Hospital
Alma St
Fremantle, WA 6160
Country 99178 0
Australia
Phone 99178 0
+61 451305593
Fax 99178 0
Email 99178 0
[email protected]
Contact person for public queries
Name 99179 0
Ashan Weerakkody
Address 99179 0
Rehabilitation in the Home
L5, Fremantle Hospital
Alma St
Fremantle, WA 6160
Country 99179 0
Australia
Phone 99179 0
+61 451305593
Fax 99179 0
Email 99179 0
[email protected]
Contact person for scientific queries
Name 99180 0
Ashan Weerakkody
Address 99180 0
Rehabilitation in the Home
L5, Fremantle Hospital
Alma St
Fremantle, WA 6160
Country 99180 0
Australia
Phone 99180 0
+61 451305593
Fax 99180 0
Email 99180 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data collected, after de-identification
When will data be available (start and end dates)?
Start: after completion of data collection period, no determined end date.
Available to whom?
Only researchers who provide a methodologically sound proposal
Study participants on request
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Subject to approvals by Principal Investigator
Contact can be made via email:
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6377Ethical approval    379030-(Uploaded-10-01-2020-13-16-11)-Study-related document.pdf



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.