Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001068853
Ethics application status
Approved
Date submitted
6/07/2021
Date registered
13/08/2021
Date last updated
2/02/2022
Date data sharing statement initially provided
13/08/2021
Date results provided
2/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
In stroke survivors, does counting and recording practice repetitions result in increased practice?
Scientific title
The effect of counting and recording repetitions on the intensity of stroke rehabilitation: A Randomised Control Trial
Secondary ID [1] 304710 0
Nil known
Universal Trial Number (UTN)
U1111-1267-6733
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 322725 0
Condition category
Condition code
Stroke 320313 320313 0 0
Ischaemic
Stroke 320314 320314 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 320465 320465 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in Group A (intervention group) - At a private rehabilitation clinic in Sydney, during five face to face physiotherapy rehabilitation sessions, the participants in the intervention group will have all repetitions done in five minutes of a target exercise counted and recorded on a practice sheet that is visible to the participant. This will be done by the treating physiotherapist who will be an experienced rehabilitation physiotherapist. The therapist will count out loud the repetitions that are being done and keep an ongoing tally. Before each new session, the therapist will show the number of repetitions completed in the previous session and set a goal that is 25% higher (for example, last session: 20 repetitions, goal for this session: at least 25 repetitions). Adherence will be monitored by examining the practice records and watching the video recording of the session.
Intervention code [1] 321089 0
Treatment: Other
Intervention code [2] 321187 0
Rehabilitation
Comparator / control treatment
Participants in Group B (control group) - At a private rehabilitation clinic in Sydney, during five face to face physiotherapy rehabilitation sessions, the participants will have therapy as usual which does not include counting and recording of repetitions of practice.
Control group
Active

Outcomes
Primary outcome [1] 328162 0
Intensity of practice measured as exercise repetitions per minute. This will be counted across a 5 minute period and the average repetitions per minute will be calculated. The counting will be done while watching a video recording of the target exercise being performed. A pre-determined definition of what constitutes one repetition will be used. This will be based on the definitions compiled by Scrivener et al (https://pubmed.ncbi.nlm.nih.gov/22878434/) "For example one stand up was recorded
as one exercise repetition, one step was recorded as a repetition and one
active ankle dorsiflexion in strength training. When the participant was
attempting to maintain a position (e.g. remain sitting/standing upright)
each effortful attempt was recorded as a repetition."
Timepoint [1] 328162 0
Session one and session 5
Secondary outcome [1] 397899 0
There is no secondary outcome
Timepoint [1] 397899 0
N/A

Eligibility
Key inclusion criteria
• Above 18 years of age
• Clinical diagnosis of stroke (ischaemic or haemorrhagic)
• Attending Advance Rehab Centre (ARC) in Sydney, Australia
• Planned to attend at least another 8 sessions of rehabilitation
• Patient can complete a minimum of 5 minutes of a rehabilitation exercise without assistance from people or devices
• Patient has appropriate cognition and English language ability to give consent and understand instructions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Co-morbidities that can reduce exercise capacity such as COPD and symptomatic osteoarthritis

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 will be concealed as the researcher will contact the holder of the allocation schedule who is "off-site". They off-site investigate will be contacted by phone and will inform the researcher of the group allocation.


Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation order will be created by using Excel software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To determine the rate of repetitions per minute, we will use the median or mean from the 5 minutes of exercise. If this data is skewed, we will use the median value, if the data is evenly distributed, we will use the mean value. For each group, data from session 1 will be compared to session 5 and the percentage increase between them will be presented using descriptive statistics. An independent t-test will be used to determine whether there are any significant differences (p <0.05) between the intervention and the control groups for changes in the rate of repetitions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/09/2021
Actual
6/09/2021
Date of last participant enrolment
Anticipated
18/10/2021
Actual
22/10/2021
Date of last data collection
Anticipated
29/10/2021
Actual
5/11/2021
Sample size
Target
30
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 34630 0
2064 - Artarmon

Funding & Sponsors
Funding source category [1] 309080 0
University
Name [1] 309080 0
Australian Catholic University
Country [1] 309080 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
PO Box 968, North Sydney NSW 2059
Country
Australia
Secondary sponsor category [1] 310026 0
None
Name [1] 310026 0
Address [1] 310026 0
Country [1] 310026 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308954 0
Australian Catholic University Research Ethics
Ethics committee address [1] 308954 0
Ethics committee country [1] 308954 0
Australia
Date submitted for ethics approval [1] 308954 0
29/04/2021
Approval date [1] 308954 0
08/07/2021
Ethics approval number [1] 308954 0

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

Contacts
Principal investigator
Name 112458 0
Dr Simone Dorsch
Address 112458 0
Australian Catholic University
PO Box 968
North Sydney
NSW 2059
or 33 Berry St
North Sydney 2060
Country 112458 0
Australia
Phone 112458 0
+61 414811168
Fax 112458 0
Email 112458 0
[email protected]
Contact person for public queries
Name 112459 0
Simone Dorsch
Address 112459 0
Australian Catholic University
PO Box 968
North Sydney
NSW 2059
or 33 Berry St
North Sydney 2060
Country 112459 0
Australia
Phone 112459 0
+61 414811168
Fax 112459 0
Email 112459 0
[email protected]
Contact person for scientific queries
Name 112460 0
Simone Dorsch
Address 112460 0
Australian Catholic University
PO Box 968
North Sydney
NSW 2059
or 33 Berry St
North Sydney 2060
Country 112460 0
Australia
Phone 112460 0
+61 414811168
Fax 112460 0
Email 112460 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 during the trial, after de-identification
When will data be available (start and end dates)?
Start date 25/02/2022
No end date determined
Available to whom?
Anyone who wishes to access it for a valid reason
Available for what types of analyses?
For any type of analysis
How or where can data be obtained?
Access subject to approvals by Simone Dorsch, [email protected]


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
No additional documents have been identified.