ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil known

Universal Trial Number (UTN)

U1111-1267-6733

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Condition category

Condition code

Stroke

Ischaemic

Stroke

Haemorrhagic

Physical Medicine / Rehabilitation

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]

Treatment: Other

Intervention code [2]

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]

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]

Session one and session 5

Secondary outcome [1]

There is no secondary outcome

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2064 - Artarmon

Funding & Sponsors

Funding source category [1]

University

Name [1]

Australian Catholic University

Address [1]

PO Box 968
NSW 2059
33 Berry St North Sydney
NSW 2060

Country [1]

Australia

Primary sponsor type

University

Name

Australian Catholic University

Address

PO Box 968, North Sydney NSW 2059

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Catholic University Research Ethics

Ethics committee address [1]

PO Box 968, North Sydney NSW 2059

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/04/2021

Approval date [1]

08/07/2021

Ethics approval number [1]

Summary

Brief summary

Background
Stroke is a cardiovascular disease that is estimated to affect 1.7% of all Australians. Due to stroke-related disabilities, 40% of patients experience limitations with walking, upper limb function and other activities, causing reduced participation in society. High intensity rehabilitation is required to optimise recovery however, this is not being achieved using current approaches to therapy. There are limited strategies for maximising intensity of stroke rehabilitation that have proven benefit and do not involve additional resources. Counting and recording repetitions is a possible solution, however, this strategy is yet to be evaluated. This study will quantify the effect of counting and recording repetitions and discussing target numbers of repetitions on the intensity of practice achieved in stroke rehabilitation. During therapy sessions for the intervention group exercise repetitions will be counted and recorded and participants will be encouraged to reach target numbers based on their previous performance. The control group will continue with usual therapy.
Significance of Research
 If this study demonstrates that counting and recording repetitions increases the intensity of practice done in rehabilitation, it could lead to changes within stroke rehabilitation that will make therapy more efficient and effective. It will provide a strategy that incrases the intensity of stroke rehabilitation with no additional resources, time or cost for the therapist or the patient. 
Aim 
Therefore, the aim of this study is to determine the impact of counting and recording repetitions on the intensity of rehabilitation (rate of repetitions) completed. It is hypothesised that this intervention will lead to a statistically and clinically relevant increase in the intensity of stroke rehabilitation. 
Objectives
•	To determine the percentage difference in the rate of repetitions between the start and end of study for both the intervention and control group.
•	To compare the percentage difference between the intervention and control group
•	To determine if counting and recording repetitions has any statistical or clinical significance in increasing the intensity of stroke rehabilitation

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Simone Dorsch

Address

Australian Catholic University
PO Box 968
North Sydney
NSW 2059
or 33 Berry St
North Sydney 2060

Country

Australia

Phone

+61 414811168

Fax

simone.dorsch@acu.edu.au

Contact person for public queries

Name

Simone Dorsch

Address

Australian Catholic University
PO Box 968
North Sydney
NSW 2059
or 33 Berry St
North Sydney 2060

Country

Australia

Phone

+61 414811168

Fax

simone.dorsch@acu.edu.au

Contact person for scientific queries

Name

Simone Dorsch

Address

Australian Catholic University
PO Box 968
North Sydney
NSW 2059
or 33 Berry St
North Sydney 2060

Country

Australia

Phone

+61 414811168

Fax

simone.dorsch@acu.edu.au

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, Simone.dorsch@acu.edu.au

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically