Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000312640p
Ethics application status
Submitted, not yet approved
Date submitted
1/03/2023
Date registered
22/03/2023
Date last updated
22/03/2023
Date data sharing statement initially provided
22/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the use of knowledge of results feedback increase stroke survivors’ motivation to practise and intensity of practice?
Scientific title
In stroke rehabilitation, does the provision of knowledge of results feedback, in addition to usual care, increase motivation to practise and intensity to practice?
Secondary ID [1] 309080 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 329143 0
Condition category
Condition code
Stroke 326121 326121 0 0
Ischaemic
Stroke 326122 326122 0 0
Ischaemic
Physical Medicine / Rehabilitation 326123 326123 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group - At a private rehabilitation clinic in Sydney, the participants in the intervention group will receive five face to face physiotherapy rehabilitation sessions, these will be at the frequency that is used for that participant (ie once a week or 3 times a week). During the physiotherapy sessions the participant will be provided knowledge of results feedback at the end of each set of exercise, in addition to their usual therapy. This will be done by the treating physiotherapist, who will record the results of each set of exercise on a practice sheet that is visible to the participant, and then discuss their results after each set of exercise (for example, last session you were able to put 20kg through your leg for 15 out of 20 repetitions. This session you were able to put 20kg through your leg for 18 out of 20 repetitions. Well done, you have improved.) This information will be given to the participants immediately after each set of exercise repetitions within the treatment session and will be recorded on a recording sheet. The same type of knowledge of results feedback will be used for each exercise across sessions so that participants can see changes in their performance. In order to assess fidelity of the intervention a researcher will observe one of the five therapy sessions for each participant in the intervention group, the session will be chosen at random.
Intervention code [1] 325525 0
Treatment: Other
Intervention code [2] 325526 0
Rehabilitation
Comparator / control treatment
Control group - The participants in the control group will receive five face to face physiotherapy rehabilitation sessions where they receive therapy as usual, which does not include receiving knowledge of results feedback. Therapy as usual consists of exercises to address impairments such as specific strengthening exercises and exercises that are task specific to the task the participant is targeting, for example balance exercises for the affected leg in order to improve balance during standing and walking. The usual therapy is aligned with the living guidelines of the Stroke Foundation located at https://app.magicapp.org/#/guideline/Kj2R8j
Control group
Active

Outcomes
Primary outcome [1] 333988 0
Motivation to practise measured using the intrinsic motivation inventory, which is a questionnaire used to measure intrinsic motivation with 45 items divided into seven subscales.
Timepoint [1] 333988 0
Baseline measurement session and session five.
Secondary outcome [1] 418957 0
Intensity of practise measured as exercise repetitions per minute. A blinded assessor will watch a video recording of the baseline and fifth physiotherapy session to count the number of exercise repetitions. The number of repetitions of each exercise will be divided by the time spent exercising to determine the rate of exercise repetitions. The change in intensity of practice will be expressed as a percentage increase in rate of repetitions from baseline to session five.

The definition of an exercise repetition will be based on the definitions by Scrivener et. al., (2012) (https://pubmed.ncbi.nlm.nih.gov/22878434/), "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] 418957 0
Baseline measurement session and session five.

Eligibility
Key inclusion criteria
- Adults aged 18 years and above with a clinical diagnosis of stroke
- Attending the Advanced Rehab Centre (ARC) Clinic in Artarmon, Sydney Australia
- Able to attend six outpatient sessions of physiotherapy (one for baseline measurement followed by five sessions)
- Participating in weight-bearing exercises to improve lower-limb tasks, such as standing and walking, for at least half of their physiotherapy session and capable of completing active exercise without physical assistance
- Sufficient cognition to follow instructions and provide informed consent
- Adequate English to follow simple instructions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Adults with diagnosed mental health disorders limiting their motivation and capacity to engage in exercise
- Co-morbidities that can reduce exercise capacity such as COPD, symptomatic osteoarthritis, chronic pain, life-limiting disease and long COVID-19

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 who is recruiting participants will contact the holder of the allocation schedule who is "off-site" in order to determine group allocation. The off-site researcher 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 the random number sequence generator in Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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 change in motivation, the change in scores on the intrinsic motivation inventory from baseline measurement to session five will be calculated for each group. Independent samples T-test will determine if there is an overall difference between the control group and intervention group in motivation scores on the intrinsic motivation inventory.

To determine the change in intensity of practice, the percentage increase of repetitions between baseline measurement and the fifth session will be evaluated. The overall percentage increase of repetitions from baseline measurement to session five will be compared. Then independent samples T-test will determine if there is a between-group difference in the increase in rate of repetitions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/05/2023
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
30/07/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 39641 0
2064 - Artarmon

Funding & Sponsors
Funding source category [1] 313284 0
University
Name [1] 313284 0
Australian Catholic University
Country [1] 313284 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
PO Box 968
NSW 2059
33 Berry St, North Sydney
NSW 2060
Country
Australia
Secondary sponsor category [1] 315024 0
None
Name [1] 315024 0
Address [1] 315024 0
Country [1] 315024 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312514 0
Australian Catholic University Research Ethics
Ethics committee address [1] 312514 0
Ethics committee country [1] 312514 0
Australia
Date submitted for ethics approval [1] 312514 0
28/11/2022
Approval date [1] 312514 0
Ethics approval number [1] 312514 0

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

Contacts
Principal investigator
Name 124930 0
Dr Simone Dorsch
Address 124930 0
Australian Catholic University
PO Box 968
North Sydney
NSW 2059
or 33 Berry St
North Sydney 2060
Country 124930 0
Australia
Phone 124930 0
+61 414811168
Fax 124930 0
Email 124930 0
[email protected]
Contact person for public queries
Name 124931 0
Simone Dorsch
Address 124931 0
Australian Catholic University
PO Box 968
North Sydney
NSW 2059
or 33 Berry St
North Sydney 2060
Country 124931 0
Australia
Phone 124931 0
+61 414811168
Fax 124931 0
Email 124931 0
[email protected]
Contact person for scientific queries
Name 124932 0
Simone Dorsch
Address 124932 0
Australian Catholic University
PO Box 968
North Sydney
NSW 2059
or 33 Berry St
North Sydney 2060
Country 124932 0
Australia
Phone 124932 0
+61 414811168
Fax 124932 0
Email 124932 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)?
Data will be available from 4th December 2023. 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.