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Trial registered on ANZCTR


Registration number
ACTRN12615001124527
Ethics application status
Approved
Date submitted
29/08/2015
Date registered
26/10/2015
Date last updated
26/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Early active arm movement to drive recovery following stroke.
Scientific title
What is the effect of an early intensive arm movement program in patients who have suffered a stroke within the past four weeks.
Secondary ID [1] 287256 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 295872 0
Condition category
Condition code
Stroke 296123 296123 0 0
Haemorrhagic
Stroke 296805 296805 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prescription of an early active movement arm program to patients with arm weakness in the acute stage post-stroke by a Physiotherapist. This will be provided in addition to usual care and routine therapy.
An evidence-based algorithm in the form of an smartphone application developed by an international working party including the applicant will be used to guide the intervention for the intervention group. This algorithm directs the therapist towards the most appropriate evidence-based therapy interventions based on the amount of residual movement in their affected arm (www.viatherapy.org/about). This will allow for the most appropriate therapy to be provided to the patient.
The research physiotherapist will prescribe a set of exercises, based on this approach, and teach them to the patient with the assistance of either their carer (where available) or the research assistant. Participants will be asked to complete their exercises for one hour each day, every day for 4 weeks. They will complete an exercise diary, and their exercises will be reviewed, progressed and updated weekly.
Intervention code [1] 292552 0
Rehabilitation
Comparator / control treatment
Usual care and routine therapy provided by a Physiotherapist. This currently involves daily physiotherapy in the acute hospital, and daily sessions of up to hour each for physiotherapy and occupational therapy on transfer to the rehab setting.
Control group
Active

Outcomes
Primary outcome [1] 295797 0
We will determine feasibility with a composite outcome including number of sessions completed and total exercise time, time spent in supervised therapy with the research assistant or caregiver, and adherence to the program.
Participants will be required to keep a diary of exercises completed, and duration of each exercise session, with the aim of achieving 60 mins of exercise each day. This diary will be reviewed by the research physiotherapist each week, as the exercise program is updated.
Timepoint [1] 295797 0
Baseline assessment on admission, post-intervention at four weeks, final follow-up at 6 months.
Secondary outcome [1] 316542 0
Amount of affected arm movement as determined by the accelerometry data.
Timepoint [1] 316542 0
Baseline assessment on admission, post-intervention at four weeks, final follow-up at 6 months.
These will be analyses within and between groups, over time.
Secondary outcome [2] 316543 0
Change in upper limb function (ARAT).
Timepoint [2] 316543 0
Baseline assessment on admission, post-intervention at four weeks, final follow-up at 6 months.
These will be analyses within and between groups, over time.
Secondary outcome [3] 317080 0
Change in amount of arm use (MAL).
Timepoint [3] 317080 0
Baseline assessment on admission, post-intervention at four weeks, final follow-up at 6 months.
These will be analyses within and between groups, over time.

Eligibility
Key inclusion criteria
Patients admitted to the Royal Adelaide Hospital (RAH) stroke unit with a confirmed diagnosis of stroke.

An ability to provide informed consent to participate in the study or a guardian/family members approval to participate.

Patients within the acute stage post-stroke (first 4 weeks post­stroke, first or recurrent stroke), with an upper-limb impairment.

All ranges of stroke severity, ages, genders and past medical history.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients deemed for palliative care.

Patient and/or therapist refusal to provide consent.

Patients unable to provide consent (dysphasia or language barrier), unable to seek guardian consent or inability to communicate in English).

Patients <18 years of age.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed via a web based randomisation system. Once a participant consents to involvement in the study, the partipant will be assessed and randomly allocated by a third party to one of these two groups using a computer generated randomisation schedule. All databases will be secured by the use of passwords.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using secure web based computer generated randomisation schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The assessor who conducts the ARAT and MAL will be blinded to group allocation.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The proposed analysis of this study will involve using descriptive statistics. These will describe the amount of use and quality of use with the arm. A between-group analysis using mixed models to examine time effects, group effects and group by time effects will be conducted. As there has been no research published in this area, using family members to assist with early arm rehab, we will be conducting a pilot study with 10 participants in each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 4173 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 10082 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 291818 0
Charities/Societies/Foundations
Name [1] 291818 0
Ian Potter Foundation
Address [1] 291818 0
Level 3, 111 Collins Street
Melbourne VIC 3000
Country [1] 291818 0
Australia
Primary sponsor type
Individual
Name
Michelle McDonnell
Address
University of South Australia
School of Health Sciences
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 290481 0
None
Name [1] 290481 0
Address [1] 290481 0
Country [1] 290481 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293338 0
Royal Adelaide Hospital Research Ethics Committee (EC00192)
Ethics committee address [1] 293338 0
North Terrace
Adelaide SA 5000
Australia
Ethics committee country [1] 293338 0
Australia
Date submitted for ethics approval [1] 293338 0
28/07/2015
Approval date [1] 293338 0
31/08/2015
Ethics approval number [1] 293338 0
HREC/15/RAH/328
Ethics committee name [2] 293339 0
University of South Australia Human Research Ethics Committee (EC00196)
Ethics committee address [2] 293339 0
Research and Innovation Services
University of South Australia
General Purpose Building
Mawson Lakes Campus
Mawson Lakes Boulevard
Mawson Lakes, SA, 5095
Australia
Ethics committee country [2] 293339 0
Australia
Date submitted for ethics approval [2] 293339 0
Approval date [2] 293339 0
Ethics approval number [2] 293339 0

Summary
Brief summary
Purpose of study is to explore the effect of an early intensive arm movement program in patients who have suffered a stroke within the past four weeks, in order to see if greater neuroplastic changes are driven resulting in improved functional recovery.

It is hypothesised that an increase in the amount of arm movement by patients in the intervention (early intensive arm movement) group will have greater arm functional recovery compared to patients in the control (usual care and routine therapy) group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59438 0
Dr Michelle McDonnell
Address 59438 0
School of Health Sciences, University of South Australia
GPO Box 2417
Adelaide SA 5001
Country 59438 0
Australia
Phone 59438 0
+61 8 8302 1684
Fax 59438 0
Email 59438 0
michelle.mcdonnell@unisa.edu.au
Contact person for public queries
Name 59439 0
Dr Michelle McDonnell
Address 59439 0
School of Health Sciences, University of South Australia
GPO Box 2417
Adelaide SA 5001
Country 59439 0
Australia
Phone 59439 0
+61 8 8302 1684
Fax 59439 0
Email 59439 0
michelle.mcdonnell@unisa.edu.au
Contact person for scientific queries
Name 59440 0
Dr Michelle McDonnell
Address 59440 0
School of Health Sciences, University of South Australia
GPO Box 2417
Adelaide SA 5001
Country 59440 0
Australia
Phone 59440 0
+61 8 8302 1684
Fax 59440 0
Email 59440 0
michelle.mcdonnell@unisa.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary