Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000082707
Ethics application status
Approved
Date submitted
30/11/2021
Date registered
21/01/2022
Date last updated
28/11/2022
Date data sharing statement initially provided
21/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
ReCITE (Remote Constraint Induced Therapy of the upper Extremity): An implementation study of remotely delivered constraint induced movement therapy for stroke survivors
Scientific title
ReCITE (Remote Constraint Induced Therapy of the upper Extremity): An implementation study to evaluate the feasibility, acceptability and safety for stroke survivors of constraint-induced movement therapy (CIMT) delivered by telehealth (TeleCIMT).
Secondary ID [1] 303117 0
Nil known
Universal Trial Number (UTN)
U1111-1271-9400
Trial acronym
ReCITE (Remote Constraint Induced Therapy of the upper Extremity)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 322153 0
Condition category
Condition code
Physical Medicine / Rehabilitation 319847 319847 0 0
Occupational therapy
Physical Medicine / Rehabilitation 319848 319848 0 0
Physiotherapy
Stroke 322250 322250 0 0
Haemorrhagic
Stroke 322251 322251 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Implementation: Outpatient therapy teams, including occupational therapists and allied health assistants, at four sites will be provided with an interactive implementation package to support delivery of constraint induced movement therapy program (CIMT) program via telehealth (TeleCIMT) in practice. Participating therapists will individually complete the two hour online TIDE (TeleCIMT International DEvelopment) TeleCIMT implementation package which includes education modules targeted at known barriers to CIMT implementation and "how to implement" the TeleCIMT program. This is readily available online via https://www.telecimt.com/. Therapists will be provided with a step by step CIMT participant workbook and access to online videos to assist with program preparation, via the TeleCIMT website. Following completion of online training, therapists will participate in a 3 hour practical workshop delivered in a hybrid format (therapists in-person in groups of 2-8 with 2 instructors from the study team delivering training online). The mode of instruction will include powerpoint presentation and pre-recorded videos of how to conduct the study screening assessments, group discussion of any areas requiring further explanation from the online training and presentation of a case study and group work to practice delivery of TeleCIMT. Adherence to therapist online training will be monitored by accessing website analytics. Following completion of modules and workshop, therapists will be involved in monthly virtual community of practice meetings, run for 12-18 months (until the final stroke participant has completed their CIMT program) to support therapists with implementing TeleCIMT into their setting.

Intervention: Within 3 months of delivery of the implementation package to therapists, adults post-stroke with upper limb activity limitations who have some active movement in the hand will complete a three week constraint induced movement therapy program (CIMT) program via telehealth (TeleCIMT). Participants will be asked to complete a minimum of two hours active practice, five days per week for three weeks. Direct therapist intervention with participants will occur via video call three days per week for one hour. Outside of these sessions, participants will complete independent structured practice with their affected arm five days per week (2 hours twice a week and 1 hour on direct therapist intervention days), for 3 weeks (15 days) using a list of pre-defined activities. These activities will be set by the therapist in consultation with the stroke survivor to align with the participant's interests and roles and will be completed with or without the support of a carer/friend/family member. Participants will also be asked to wear a mitt restraint on the unaffected hand for 6 hours per day. Participants will also have a short (10-20 minutes) daily telephone call with their treating therapist (Monday-Friday) to receive support to problem solve strategies to increase use of their affected arm (CIMT transfer package).
Adherence to the mitt wear and structured practice will be recorded in the participant's workbook with or without help from the support person and also recorded by the therapists during the daily phone calls.
Intervention code [1] 320729 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329672 0
Within group difference pre-post TeleCIMT program in self reported amount of arm and hand use (AoU) and quality of arm movement (QoM) as measured by the Motor Activity Log (MAL). The Motor Activity Log is a composite measure.
Timepoint [1] 329672 0
Baseline, at the end of TeleCIMT (week 3) (primary timepoint) and one month post program (week 7).
Primary outcome [2] 329674 0
Within group difference pre-post TeleCIMT program in fine dexterity as measured by the Nine Hole Peg Test (NHPT)
Timepoint [2] 329674 0
Baseline, at the end of TeleCIMT (week 3) (primary timepoint) and one month post program (week 7).
Primary outcome [3] 329675 0
Feasibility of therapist behaviour change and implementation of TeleCIMT into routine practice assessed by evaluation the number of stroke survivors recruited for TeleCIMT at each site as a proportion of those who are deemed eligible for CIMT - determined by an audit of study screening logs.
Timepoint [3] 329675 0
Following the delivery of the implementation package to therapists (baseline) and following recruitment of 30 stroke survivor participants (primary endpoint)
Secondary outcome [1] 403412 0
Within group difference pre-post TeleCIMT program in arm function as measured by the Action Research Arm Test (ARAT).
Timepoint [1] 403412 0
Baseline, at the end of TeleCIMT (week 3) (primary timepoint) and one month post program (week 7).
Secondary outcome [2] 403413 0
Within group difference pre-post TeleCIMT program in physical function as measured by the Stroke Impact Scale.
Timepoint [2] 403413 0
Baseline, at the end of TeleCIMT (week 3) (primary timepoint) and one month post program (week 7).
Secondary outcome [3] 403414 0
Within group difference pre-post TeleCIMT program in self-reported quality of life as measured by the EQ-5D-5L.
Timepoint [3] 403414 0
Baseline, at the end of TeleCIMT (week 3) (primary timepoint) and one month post program (week 7).
Secondary outcome [4] 403415 0
Adherence to the TeleCIMT online implementation package through examination of completion rates of each TeleCIMT implementation module using website analytics
Timepoint [4] 403415 0
Two weeks after the start of the implementation component of the project and following completion of the 30 CIMT participants
Secondary outcome [5] 403416 0
Acceptability of the TeleCIMT implementation package and intervention via review of transcripts from post implementation interviews with therapists
Timepoint [5] 403416 0
Following the recruitment of the 30 stroke survivor participants
Secondary outcome [6] 403417 0
Within group difference pre-post TeleCIMT program in gross motor function as measured by the box and blocks test.
Timepoint [6] 403417 0
Baseline, at the end of TeleCIMT (week 3) (primary timepoint) and one month post program (week 7).
Secondary outcome [7] 404610 0
Acceptability of the TeleCIMT implementation package and intervention via review of transcripts from post implementation interviews with stroke participants
Timepoint [7] 404610 0
At the end of a participant's TeleCIMT program (between weesk 4-7)
Secondary outcome [8] 416226 0
Acceptability of being a supporter for a TeleCIMT program assessed using the Theoretical Framework of Acceptability questionnaire for supporters of a stroke survivor completing TeleCIMT
Timepoint [8] 416226 0
Within 4 weeks of completion of TeleCIMT
Secondary outcome [9] 416227 0
Change in therapists’ knowledge, skills and confidence in delivering TeleCIMT will be measured using the self-evaluation Capabilities, Opportunities, Motivation-Behaviour questionnaire.
Timepoint [9] 416227 0
Prior to commencing online training modules, after completing online training modules and after completing practical workshop.

Eligibility
Key inclusion criteria
Stroke participants:
Adults who have sustained a stroke resulting in mild to moderate upper limb impairments with retention of some active thumb extension and finger extension in at least two fingers.
Medically stable and able to participate in intensive rehabilitation as assessed by the treating rehabilitation clinician.
Read and understand English to provide written or oral consent and able to understand TeleCIMT supporting video and written resources.
Able to adequately communicate to participate in self rating measures of performance and reporting of home practice.
Have access to the internet and a suitabe electronic device to access online TeleCIMT supporting videos.
Have adequate cognitive ability to participate in a CIMT program with the assistance of a supporter (Montreal Cognitive Assessment score of 26 or above).
Therapist participants:
Be an occupational therapist, physiotherapist or allied health assistant involved in the delivery of the TeleCIMT program
Provide written or oral consent to be interviewed
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Stroke Participants:
Do not live in the catchment area of the therapy teams involved; have upper limb comorbidities (e.g. extreme pain and/or unstable lymphoedema); have had a previous neurological event (e.g. previous stroke).

Therapist participants will be excluded if they have received/seen less than 10 referrals for upper limb rehabilitation post-stroke in the previous year.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
10/05/2022
Date of last participant enrolment
Anticipated
1/04/2023
Actual
Date of last data collection
Anticipated
1/06/2023
Actual
Sample size
Target
30
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 21198 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 21199 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [3] 21200 0
St Joseph's Hospital - Auburn
Recruitment hospital [4] 23644 0
Golf Links Road Rehabilitation Centre - Frankston
Recruitment postcode(s) [1] 36066 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 36067 0
2144 - Auburn
Recruitment postcode(s) [3] 36065 0
2170 - Liverpool
Recruitment postcode(s) [4] 39065 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 307524 0
Charities/Societies/Foundations
Name [1] 307524 0
Stroke Foundation (Early Career Seeding Grant Scheme)
Country [1] 307524 0
Australia
Funding source category [2] 310235 0
Charities/Societies/Foundations
Name [2] 310235 0
St Vincent's Clinic Foundation
Country [2] 310235 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Health Network Sydney Limited
Address
St Vincent's Hospital Sydney
390 Victoria Street
Darlinghurst
NSW 2010
Country
Australia
Secondary sponsor category [1] 311330 0
None
Name [1] 311330 0
Address [1] 311330 0
Country [1] 311330 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307591 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 307591 0
St Vincent's Hospital Translational Research Centre
97-105 Boundary St
Darlinghurst NSW 2010
Ethics committee country [1] 307591 0
Australia
Date submitted for ethics approval [1] 307591 0
31/05/2021
Approval date [1] 307591 0
01/07/2021
Ethics approval number [1] 307591 0
2021/ETH01131

Summary
Brief summary
Constraint-induced movement therapy (CIMT) is an effective intervention for arm recovery after stroke. CIMT is recommended in national guidelines, yet only 11% of eligible stroke survivors receive CIMT. Telehealth provides opportunities to deliver CIMT to stroke survivors who live regionally or without transport. Early studies have achieved similar outcomes delivering CIMT via telehealth or online compared to face-to-face. However, implementation support was not provided in any study to embed TeleCIMT into practice.
The TeleCIMT International DEvelopment group of occupational therapists, physiotherapists and researchers from Australia, United Kingdom and New Zealand have developed resources to support CIMT implementation and delivery by telehealth (TeleCIMT) in response to the COVID-19 pandemic.
This prospective, single-group implementation study will evaluate the feasibility of TeleCIMT using TIDE resources, and explore therapists’ experiences and use of online implementation resources to support TeleCIMT delivery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107786 0
Dr Lauren Christie
Address 107786 0
Nursing Research Institute,
Level 5 deLacy building,
St Vincent's Hospital,
390 Victoria Street
Darlinghurst NSW 2010
Country 107786 0
Australia
Phone 107786 0
+61 0283824023
Fax 107786 0
Email 107786 0
lauren.christie@svha.org.au
Contact person for public queries
Name 107787 0
Dr Lauren Christie
Address 107787 0
Nursing Research Institute,
Level 5 deLacy building,
St Vincent's Hospital,
390 Victoria Street
Darlinghurst NSW 2010
Country 107787 0
Australia
Phone 107787 0
+61 0283824023
Fax 107787 0
Email 107787 0
lauren.christie@svha.org.au
Contact person for scientific queries
Name 107788 0
Dr Lauren Christie
Address 107788 0
Nursing Research Institute,
Level 5 deLacy building,
St Vincent's Hospital,
390 Victoria Street
Darlinghurst NSW 2010
Country 107788 0
Australia
Phone 107788 0
+61 0283824023
Fax 107788 0
Email 107788 0
lauren.christie@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is not yet known if there will be a plan to make IPD available.


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
EmbaseRemote constraint induced therapy of the upper extremity (ReCITE): A feasibility study protocol.2022https://dx.doi.org/10.3389/fneur.2022.1010449
N.B. These documents automatically identified may not have been verified by the study sponsor.